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Bulgarian Health Act, part 2
Last update: 2008-08-22 01:26:09

Bulgarian Health Act, part 2

Section III
Assisted Reproduction


Article 129
Assisted reproduction shall be applied, where the condition of the man or the woman prevents the natural performance of their reproductive functions.
Article 130
(1) Assisted reproduction shall be carried out upon the informed consent given in writing by the persons willing to have progeny.
(2) Assisted reproduction shall be carried out after the conduct of medical tests to guarantee the health of the progeny.
(3) (Amended, SG No. 71/2006) Assisted reproduction shall be carried out in accordance with the medical standards approved by an ordinance of the Minister of Health.
(4) (New, SG No. 71/2006) Assisted reproduction shall include the activities related to:
1. the application of medical methods for fertilization of an ovum located inside or outside the body of the woman;
2. the extraction, expert testing, processing, labelling and storage of ova, spermatozoids or zygotes;
2. the extraction of an ovum from one woman and the implantation thereof into the body of the same woman;
4. the extraction of an ovum from one woman and the implantation thereof into the body of another woman.
(5) (New, SG No. 71/2006) Extraction of ova from a donor in the cases referred to in Item 4 of Paragraph (4) may be effected providing the following conditions have been met:
1. the donor is of full age and has not been placed under interdiction;
2. a written agreement from the donor has been received, notarized by a notary in whose judicial district the medical establishment which will implement the extraction is located;
3. the donor has been informed in understandable language as regards the risks that person is undertaking.
4. the physical and mental health of the donor has been established with a memorandum signed by the members of a commission appointed by the director of the medical establishment implementing the extraction, which shall consist of at least three doctors who do not participate in the team on the extraction.
(6) (New, SG No. 71/2006) Medical establishments shall be obligated to prepare an annual report on the activities implemented pursuant to Paragraph (4) in a from established by the ordinance referred to in Article 131 (3) and shall submit it to the Executive Agency on Transplantation.
(7) (New, SG No. 71/2006) Offering pecuniary benefit to a donor of ova or spermatozoids, as well as acceptance of pecuniary benefit by the donor shall be prohibited.
Article 131
(Amended, SG No. 71/2006)
(1) Assisted reproduction, as well as the provision, use and storage of human ova, spermatozoids and zygotes shall be implemented by medical establishments that have received a permit from the Minister of Health under conditions and by a procedure set down by an Ordinance of the Minister of Health.
(2) Medical establishments shall carry out all medical activities related to the testing, preparation and continuous monitoring of the persons subjected to assisted reproduction, and shall control the condition of their health until childbirth.
(3) The terms and conditions for the extraction, placement, medical expert opinion, processing, labelling and storage of ova, spermatozoids and or zygotes for the needs of assisted reproduction, as well as of the materials and products coming in contact therewith and their tracking from the donor to the recipient, shall be determined by an ordinance issued by the Minister of Health and shall be controlled by the Executive Agency on Transplantation.
Article 132
(1) (Amended, SG No. 71/2006) The medical establishments referred to in Article 131 (1) shall create and maintain a register that shall contain:
1. data about each case of extraction, medical expert opinion, processing, labelling and storage of ova, spermatozoids and or zygotes;
2. the forename, patronymic and family name, personal identity number, permanent address and unique identification number of the persons who have donated ova or spermatozoids;
3. the unique identification number of extracted ova, spermatozoids or zygotes, related to the number pursuant to Item 2.
4. the forename, patronymic and family name, the personal identity number, permanent address and unique identification number of the woman to whom ova, spermatozoids or zygotes have been implanted, related to the number pursuant to Item 3.
(2) Any disclosure of data which may lead to identification of donors or recipients of ova or spermatozoids, where the donor is a person other than the man or woman willing to have progeny, shall be prohibited, unless ruled otherwise by law.
(3) The data in the register under Paragraph (1) shall be deemed to be official information and shall be kept for 30 years.
(4) (Amended, SG No. 71/2006) The terms and conditions for the registration, processing, storage and provision of the information in the register under Paragraph (1) shall be set out in the ordinance under Article 131 (3).
Article 132a
(New, SG No. 71/2006)
(1) The medical establishments referred to in Article 131 (1) shall be obligated to notify the Executive Agency on Transplantation within seven days of establishment of all grave unwanted reactions or serious incidents where these are the result of extraction, medical expert opinion, processing, labelling and storage of ova, spermatozoids and or zygotes and are related to the quality and safety thereof.
(2) The medical establishments pursuant to Article 131 (1) shall be obligated to create and apply a system for immediate blocking, withdrawal or destruction of all ova, spermatozoids or zygotes which may lead to a grave unwanted reaction or a serious accident.
(3) The conditions and procedure for notification, registration, reporting and relay of information about the grave unwanted reactions and the serious accidents, as well as for blocking, withdrawal and destruction of ova, spermatozoids or zygotes shall be determined by an ordinance of the Minister of Health.
Article 132b
(New, SG No. 71/2006)
(1) Medical establishments shall be obligated to label the extracted ova, spermatozoids and zygotes.
(2) The medical establishments referred to in Article 131 (1) shall be obligated to create conditions for tracking the ova, spermatozoids and zygotes, as well as the products and materials that come into contact therewith and are related to their quality and safety, under conditions and by a procedure established by the ordinance referred to in Article 131 (3).
Article 133
No artificial fertilization of an ovum with spermatozoids of a donor who in blood kin of direct or collateral lineage up to four times removed to the woman to whom the ovum belongs shall be allowed. These circumstances shall be certified with a statement in writing by the persons willing to have progeny.
Article 134
(1) (New, SG No. 71/2006) Export and import of ova, spermatozoids and zygotes shall be effected under conditions and by the procedure of Articles 36, 37 and 38 of the Organ, Tissue and Cell Transplantation Act .
(2) (Previous Article 134, SG No. 71/2006) Ova, spermatozoids and fertilized ova which have not been used for creating progeny may be provided to research, educational and medical establishments in this country and abroad for medical, research and educational purposes upon receipt of the informed consent in writing of the donor or, in the case of fertilized ova, by the two donors under terms and conditions set out in an ordinance issued by the Minister of Health.
Article 135
(1) Assisted reproduction techniques for selection of the gender of the progeny shall be prohibited, unless gender related hereditary diseases have to be prevented.
(2) Assisted reproduction techniques for transmission of the genetic information of one individual only shall be prohibited.
(3) The reproductive cloning of people shall be prohibited, including that for the purposes of donating organs, tissues and cells.
(4) Any intervention aimed at modifying the human genome may be undertaken only for preventive or therapeutic purposes and not for the purposes of introducing the modification into the genome of the progeny.
Article 136
Any form of genome-based discrimination shall be prohibited.


Section IV
Genetic Health and Genetic Tests
Article 137
The protection of genetic health shall be ensured through health activities aimed at:
1. preventive and diagnostic tests to prove and classify genetic diseases;
2. dispensary registration of persons with higher risk of occurrence and development of genetic diseases;
4. treatment of hereditary diseases, innate anomalies and predispositions;
4. identification of hereditary signs and identification of a parent;
5. preservation of genetic information.
Article 138
Preventive genetic tests shall be conducted for the following purposes;
1. to identify the risk of occurrence of a genetic diseases in the progeny;
2. to identify clinically healthy carriers of genetic deviations;
3. to diagnose hereditary and other diseases before and during pregnancy and after birth.
Article 139
(1) Genetic tests before childbirth shall be conducted in cases of proven risk of transmission of a genetic disease to the progeny.
(2) The tests under Paragraph 1 shall be carried out under medical control and shall include:
1. proving genetic deviations in cases of clinically healthy and ill patients;
2. establishing predisposition to a genetic disease;
3. establishing genetic deviations as a result of the life style or the external environment;
4. proving genetic diseases upon their clinical manifestation.
Article 140
Special studies shall be conducted to establish the type and frequency of genetic deviations and to identify the genetic stock through national health programmes.
Article 141
(1) Genetic tests and the taking of biological material for genetic tests for medical or research purposes shall be carried out only upon receipt of the informed consent of the tested persons given in writing.
(2) Genetic tests of children, persons with mental disorders and persons put under legal incapacity shall be carried out also at the permission of the commission for medical ethics at the respective medical establishment.
(3) The results of genetic tests and screening may not be used for discrimination against the tested persons.
(4) The information about the human genome of persons shall constitute personal data and may not be disclosed to employers, health insurance organisations and insurance companies.
Article 142
(1) Genetic tests for medical or research purposes shall be carried out by accredited:
1. genetic laboratories at medical establishments for hospital aid;
2. genetic laboratories at medical establishments for outpatient aid;
3. independent laboratories.
(2) The Minister of Health shall issue an order on the National Genetic Laboratory.
(3) The laboratory under Paragraph 2 shall provide methodological guidance and supervision of the activities of genetic laboratories.
(4) The National Genetic Laboratory shall establish and maintain a national genetic register.
(5) The terms and conditions for the operation of the National Genetic Laboratory and the register under Paragraph 4 shall be set out in an ordinance issued by the Minister of Health.
Article 143
(1) The medical establishments under Article 142, Paragraph 1 shall inform the National Genetic Laboratory on a monthly basis of the genetic tests performed and the results thereof.
(2) The medical establishments under Paragraph 1 shall establish and maintain an administrative register of the tests they have performed.
(3) The structure of the laboratories under Paragraph 1 shall be set out in an ordinance issued by the Minister of Health, while their activities and the procedures for registration, storage, processing and access to the information in the register shall be set out in the ordinance under Article 142, Paragraph 5.
Article 144
(1) The genetic laboratories at medical establishments may set up DNA banks for taking and keeping genetic material for research and medical purposes.
(2) The medical establishments under Paragraph 1 shall register their DNA banks with the Ministry of Health within seven days under terms and conditions set out in the ordinance under Article 142, Paragraph 5.


Chapter Five
MENTAL HEALTH


Section I
Protection of Mental Health
Article 145
(1) Central and local government authorities and nongovernmental organisations shall organise activities for the protection of mental health related to:
1. the provision of accessible and high-quality medical aid, care and support to persons with mental disorders, which they need for their life in the family and the community;
2. the protection of the mental health in risk groups: children, students, aged people, persons at social welfare establishments, servicemen, arrested persons and prisoners;
3. the active prevention of mental disorders;
4. the support to public initiatives in the field of mental healthcare;
5. the specialised continued training of persons involved in the protection of mental health;
6. the implementation of mental health strengthening and protection training programmes for the persons who train and perform medical activities, social adaptation, organisation and management, and protection of the public order;
7. applied research oriented to the strengthening of mental health;
8. public awareness of mental health issues.
(2) Local governments shall create conditions for psycho social rehabilitation and financial and material support, including housing, to persons with mental disorders.
Article 146
(1) Persons with mental disorders in need of special healthcare are as follows:
1. mental patients with established serious mental dysfunction (psychosis or severe disorder of the personality) or pronounced long-term mental damage as a result of a mental disease;
2. persons with moderate, severe or deep mental handicap or vascular and senile dementia;
3. persons with other mental dysfunctions, learning handicaps and adaptation difficulties, which require medical aid, care and support to live fully in the family and the community.
(2) Any person with mental disorders shall receive treatment and care under conditions equal to those offered to other patients.
Article 147
(1) No person may be subject to medical activities for the establishment or treatment of a mental disorder, unless prescribed by law.
(2) The assessment of an existing mental disorder may not be based on family, professional or other conflicts or information of a mental disorder in the past.
Article 148
The following fundamental principles shall apply to the treatment of persons with mental disorders:
1. minimization of the restriction of personal freedom and respect for the patient's rights;
2. reduction of the institutional dependence of persons with mental disorders on long-term hospital treatment provided that this does not contravene the established medical standards;
3. development of a broad network of specialised establishments for outpatient psychiatric aid and priority of the care in the family and the community;
4. integration and equality of psychiatric care among the other branches of medicine;
5. observance of humanitarian principles and norms in the therapeutic process and social adaptation;
6. encouragement of self-assistance and mutual assistance and active public and professional support to persons with mental disorders;
7. specialised training, vocational training and re-training of persons with mental disorders with a view to their social adaptation;
8. participation of humanitarian non-governmental organisations in the process of treatment and social adaptation.
Article 149
(1) The treatment of persons with mental disorders shall be carried out by medical establishments for primary or specialised outpatient aid, medical establishments for mental hospital care, dispensaries, specialised wards in multi profile hospitals and medical and social care homes.
(2) The medical activities related to the treatment of persons with mental disorders shall include diagnostic tests, pharmaceutical and instrumental methods of treatment and psychotherapy. The terms and conditions for their performance shall be set out in an ordinance issued by the Minister of Health.
(3) The use of surgical methods for change of the morphology of the central nerve system with a view to attaining specific psychic characteristics shall be prohibited.
Article 150
(1) Measures for temporary physical constraint may be applied to patients with established mental dysfunction in a condition that represents a direct and immediate threat to their own life and health or the life and health of other people.
(2) The measures under Paragraph 1 shall be applied only as a precondition for the treatment and shall not replace the active treatment.
(3) The undertaking of temporary physical constraint measures shall be performed at the instructions of a medical doctor, specifying the type of measure and its duration. This duration may not be longer than six hours.
(4) The measures under Paragraph 1 shall be carried out by staff specially trained for this purpose.
(5) The type of the physical constraint measures undertaken, the reasons for their undertaking, their duration and the name of the medical doctor who has given the instructions shall be entered into a special journal of the medical establishment and in the history of the case.
(6) The person under physical constraint measures shall be continuously monitored by a medical doctor or a nurse.
(7) The type and manner of applying physical constraint measures shall be set out in the established medical standards.
(8) The terms and conditions for the application of physical constraint measures shall be set out in an ordinance issued by the Minister of Health together with the Minister of Justice.
Article 151
(1) The labour therapy of persons with mental disorders shall be incorporated in psycho-social rehabilitation programmes.
(2) All forms of exploitation and coercion shall be ruled out in the implementation of labour therapy.
(3) The activities related to the organisation, working conditions and remuneration of work shall be set out in an ordinance issued by the Minister of Health in consultation with the Minister of Labour and Social Policy and the Minister of Finance.
Article 152
(1) Specialised institutions for social services to persons with mental disorders shall establish health offices with a medical doctor, a paramedic or a nurse.
(2) Health offices shall perform activities involving:
1. continuous medical monitoring;
2. the provision of first medical aid;
3. control of the hygiene of persons;
4. operational control over the observance of sanitary requirements;
5. the preparation and keeping of medical documentation of each person.
Article 153
(1) Urgent psychiatric aid is a set of medical rules and activities applied to persons with apparent signs of mental disorders, where their behaviour of condition represents a direct and immediate threat to their own life and health or the life and health of other people.
(2) Urgent psychiatric aid shall be provided by psychiatric dispensaries, medical establishments for mental hospital aid, psychiatric wards or clinics at multi-profile hospitals and urgent medical aid centres.
(3) Urgent psychiatric aid shall be provided in accordance with the established medical standards.
Article 154
(1) Where the condition of a person under Article 146, Paragraph 1, Items 1 and 2 warrants continuation of the treatment after the urgent condition is put under control, the head of the medical establishment shall make a decision to have the person temporarily accommodated for treatment for not more than 24 hours, informing the patient's relatives thereof forthwith.
(2) By way of exception, the term under Paragraph 1 may be renewed by up to 48 hours with the permission of the district judge.
(3) If a decision to conduct mandatory treatment is needed, the head of the medical establishment shall immediately petition the court and serve also an opinion on the mental condition of the person drawn up by a psychiatrist.


Section II
Mandatory Accommodation and Treatment
Article 155
Subject to mandatory accommodation and treatment shall be the persons under Article 146, Paragraph 1, Items 1 and 2 who, due to their disease, may commit an offence threatening their relatives, the people around them or the community or seriously threatening their health.
Article 156
(1) The mandatory accommodation and treatment of the persons under Article 155 shall be implemented upon a decision of the district court at the current address of the person or, in the cases under Article 154, of the district court at the location of the medical establishment.
(2) The mandatory treatment aid shall be provided by medical establishments for mental hospital aid and psychiatric dispensaries, psychiatric wards or clinics at multi-profile hospitals and medical establishments for specialised psychiatric outpatient aid.
Article 157
The mandatory accommodation and treatment may be demanded by the public prosecutor and, in the cases under Article 154, Paragraph 3, also by the head of the medical establishment.
Article 158
(1) The court shall send copies of the request for mandatory accommodation and treatment of the person whose case will be heard. The person may raise objections and produce evidence within seven days.
(2) The court shall hear the case in a public session with the participation of the person within 14 days of the date of the request.
(3) Where the district judge has given the permission under Article 154, Paragraph 2, and the court shall hear the case immediately and the provisions of Paragraph 1 shall not apply. The copies shall be delivered during the court session and the head of the medical establishment shall make arrangements for the person to appear.
(4) The participation of a psychiatrist, legal defence and a public prosecutor shall be mandatory.
(5) The person whose case is heard shall be questioned in person and, if necessary, brought to the court room. Where the health condition of the person prevents him/her from appearing in the court session, the court shall acquire immediate impressions of the person's condition.
Article 159
(1) The court shall issue instructions on the preparation of a forensic expert medical opinion and report, having established the existence of any of the circumstances under Article 155 and having heard a psychiatrist as to the likelihood of a mental disorder of the person. The court shall rule on the form of the forensic expert medical activities - outpatient or hospital.
(2) The court shall designate the medical establishment and the expert to perform the forensic expert medical activities and the time limits for their performance, which may not be longer than 14 days, and schedule the next court session on the case within 48 hours of the completion of the forensic expert medical opinion and report.
(3) Where the time limits for the forensic expert medical opinion and report prove insufficient, by way of exception, the court may rule in a public session to renew it once by up to ten days. In such cases, the court shall reschedule the court session scheduled under Paragraph 2.
(4) Where the court establishes that the circumstances under Article 155 do not exist or it is not established that the person has a mental disorder after the hearing of the psychiatrist, the proceedings shall be dropped.
Article 160
(1) The forensic expert medical opinion and report shall be performed under terms and conditions set out in an ordinance issued by the Minister of Health and the Minister of Justice.
(2) During the conduct of the forensic expert medical activities, no treatment shall be applied, except for urgent conditions and upon the informed consent of the person.
(3) The expert shall give the forensic expert medical opinion and report, as well as an opinion on the capability of the person of giving an informed consent with the treatment, a proposal for the treatment of the respective disease, and a recommendation on the medical establishments to perform the treatment.
Article 161
(1) The court ruling on the dropping of proceedings or the appointment of forensic expert medical activities shall be subject to private appeal or protest within three days. The appeal shall stay the forensic expert medical activities, unless the court rules otherwise.
(2) The regional court shall rule in a public session. The failure of the person to appear without any cogent reasons shall be no obstacle to the hearing of the case.
Article 162
(1) Having heard the person with regard to the forensic expert medical opinion and report, the court shall rule on the case on the basis of the evidence collected.
(2) In its judgement, the court shall rule on the need for mandatory accommodation and specify the medical establishment, as well as the existence or non-existence of capability of the person to give informed consent. The court shall establish the duration of the accommodation and treatment, as well as the form of treatment - outpatient or hospital.
(3) Where non-existence of capability of the person is assumed, the court shall rule on mandatory treatment and appoint a person from among the relatives of the patient to give the informed consent with the treatment. In the case of conflict of interests or lack of relatives, the court shall appoint a representative of the municipal healthcare service or a person designated by the mayor of the municipality to give the informed consent with the treatment of the person.
Article 163
(1) The court judgement shall be subject to appeal by the parties concerned within seven days of its ruling. The regional court shall rule within seven days and its judgement shall not be subject to appeal.
(2) The appeal against a judgement on mandatory accommodation and treatment shall stay its enforcement, unless the first instance or appellate court rules otherwise.
Article 164
(1) The mandatory treatment shall be terminated upon the expiration of the time limit for which it was adjudicated or at a decision of the district court at the location of the medical establishment.
(2) The district court at the location of the medical establishment shall rule ex officio on a quarterly basis and in accordance with the forensic expert medical opinion and report whether to terminate the mandatory accommodation and treatment or to continue the mandatory accommodation and treatment pursuant to Arts. 158, 159, 160 and 161.
(3) Where the prerequisites for mandatory accommodation and treatment are eliminated prior to the expiration of the time limits, the court may terminate the mandatory accommodation and treatment at the request of the person, the public prosecutor or the head of the medical establishment.
Article 165
(1) The provisions of the Criminal Procedure Code shall apply, unless this Section provides for some special rules.
(2) The enforceable judgement on mandatory accommodation and treatment and the court ruling on a forensic expert medical activities shall be implemented by the respective medical establishments with the assistance of the authorities of the Ministry of Interior, if needed.


Chapter Six
NON-CONVENTIONAL METHODS FOR FAVOURABLE IMPACT ON INDIVIDUAL
HEALTH


Article 166
(1) The Minister of Health shall control the application of non-conventional methods for favourable impact on individual health, including:
1. the use of non-pharmaceutical products of organic origin;
2. the use of non-pharmaceutical products of mineral origin;
3. the use of non-conventional physical methods;
4. homeopathy;
5. acupuncture and acupressure;
6. iris, pulse and auricular methods of testing;
7. dietetics and curative hunger.
(2) The use of non-conventional methods for favourable impact on individual health other than those under Paragraph 1 shall be prohibited.
(3) The Minister of Health shall issue an ordinance to set out the requirements to persons applying non-conventional methods for favourable impact on individual health.
Article 167
(1) (Supplemented, SG No. 59/2006) Eligible to practice non-convention methods under Article 166 (1), except for homeopathy, shall be Bulgarian citizens and citizens of a European Union member-state, the other states from the European economic space and Switzerland, who are mentally healthy, who have not been convicted for felony and who meet any of the following conditions:
1. they are holders of a master's degree in the professional areas of medicine, dental medicine or pharmacology;
2. (amended, SG No. 85/2005) they are holders of a specialist's or bachelor's degree in the professional area of health care;
3. they are holders of secondary education diploma and a certificate of completed training of at least four semesters at a higher medical school under terms and conditions set out in an ordinance issued by the Minister of Health and the Minister of Education and Science.
(2) (Supplemented, SG No. 59/2006) Eligible to practice homeopathy shall be Bulgarian citizens and citizens of a European Union member-state, the other states from the European economic space and Switzerland, who are holders of a masters degree in the professional areas of medicine or dental medicine.
Article 168
Persons practising non-conventional methods shall:
1. act in good faith;
2. prevent any harm to the health of the persons seeking their assistance;
3. explain to the persons seeking their assistance in detail and in a comprehensible language what non-conventional method they will apply and what results they expect;
4. obtain the explicit consent of the persons seeking their assistance on the application of the respective method given in writing;
5. not mislead the persons seeking their assistance, including the opportunities for achieving an impact on their health condition through the non-conventional method practised.
Article 169
All forms of advertising non-conventional methods, including their association with preventive, diagnostic, therapeutic and rehabilitation activities shall be prohibited.
Article 170
(1) Persons practising non-conventional methods shall register at the RHC in the region where they operate by serving an application with documents certifying the meeting of the requirements under Article 167 attached thereto.
(2) The application shall give an exhaustive description of the non-conventional methods and means that the person will apply.
(3) Where the documentation is incomplete or the registration requirements are not met, the RHC director shall advise the person thereof within 15 days and give a ten-day time limit for removal of inconsistencies.
(4) Within 15 days of the date of the application or the removal of inconsistencies, the RHC director shall issue a registration certificate, specifying the types of non convention methods to be applied by the person or refuse to issue such a certificate with the reasons thereof.
(5) The RHC director may refuse to register the applicant, where the non-conventional method described in the application contravenes the statutory requirements.
(6) The refusal to register an applicant shall be subject to appeal pursuant to the Administrative Procedure Code.
(7) A registration fee shall be paid in amounts set by the Council of Ministers.
Article 171
(1) The regional healthcare centre shall establish and maintain a register of persons practising non-conventional methods. The register shall be public and include:
1. the number of the entry;
2. the date of the non-conventional practice registration certificate;
3. details of the person practising non-conventional methods - name, personal identification number and permanent address;
4. a description of the non-conventional method practised by the person;
5. the registration number of the visitors' journal under Article 173;
6. the date of deletion of the registration and the reasons thereof;
7. any changes of the circumstances set out in items 1 to 6;
6. any comments on the registered circumstances.
(2) Registered persons shall advise the respective RHC of any change in the non-conventional practice registration within seven days of its occurrence.
Article 172
(1) The registration shall be deleted in any of the following cases:
1. at the request of the person who has registered the non conventional practice;
2. upon the death of the registered person or putting him/her under legal incapacity;
3. in the case of presenting untrue statements in the documents under Article 170, Paragraph 1;
4. in the case of activities in violation of the registration;
5. upon the establishment of unfavourable effects on human health as a result of the non-convention methods applied by the registered person.
(2) The registration shall be deleted at an order of the RHC director.
(3) The orders under Paragraph 1, Items 3, 4 and 5 shall be subject to appeal pursuant to the Administrative Procedure Code.
(4) The appeal against an order shall not stay its enforcement.
Article 173
(1) Persons practising non-conventional methods shall enter the details of each person seeking their assistance in the visitors' journal as follows:
1. the date of each visit;
2. the number of each visit;
3. the full name, personal identification number and permanent address;
4. all complaints reported during the visit;
5. the non-conventional activities performed.
(2) The visitors' journal shall be bound, sealed and registered by the RHC which has made the registration.
(3) Persons practising non-conventional methods shall keep the visitors' journal for ten years after its finalization and submit it to controlling authorities upon request.


Chapter Seven
MEDICAL EDUCATION. MEDICAL PROFESSION. MEDICAL RESEARCH
ON PEOPLE. MEDICAL SCIENCE


Section I
Medical Education
Article 174
(1) Medical education shall provide and guarantee the volume and quality of training of the medical and non-medical specialists working in the national healthcare system.
(2) The fundamental principles of medical education shall be as follows:
1. continuous and high-quality teaching and mastering of a guaranteed volume of theoretical knowledge and practical skills;
2. stage-by-stage conduct and continuous nature of the training;
3. freedom of choice of a specialty.
Article 175
(1) The training for and acquisition of a master's degree in specialties from the professional areas of medicine, dental medicine, pharmacology and public health shall be organised and conducted at departments of higher schools accredited under the Higher Education Act.
(2) (Amended, SG No. 85/2005, effective 1.09.2006) The training for and acquisition of a bachelor–Ęs degree in specialties from the professional area of public health and as nurse and midwife from the professional area of health care shall be organised and conducted at departments and/or branches of higher schools accredited under the Higher Education Act.
(3) (Amended and supplemented, SG No. 85/2005, effective 1.09.2006, amended, SG No. 41/2007) The training for and acquisition of a bachelor's under Article 42, Paragraph 1, item 1, letter "a" of the Higher Education Act degree in specialties from the professional areas of health care dental medicine, pharmacology and public health shall be organised and conducted at colleges accredited under the Higher Education Act.
(4) The training for the acquisition of a doctor's degree in scientific specialties in the field of healthcare shall be conducted at higher schools, the Bulgarian Academy of Sciences, national centres for public health affairs and other research organisations accredited under the Higher Education Act.
Article 176
(1) Upon receiving their diplomas, all medical doctors and doctors of dental medicine shall take the Hippocratic oath. The text of the oath shall be adopted by the Supreme Medical Council.
(2) (Supplemented, SG No. 85/2005) Nationals of EU Member States, other states from the European economic community and Switzerland, shall be provided an oath suitable in content and form.
Article 177
(Amended, SG No. 85/2005)
The Council of Ministers shall adopt uniform state requirements to the acquisition of higher education in specialties of regulated profession from the professional areas of medicine, dental medicine, pharmacology and health care at the proposal of the Minister of Health.
Article 178
(1) (Amended, SG No. 41/2007) Post-graduate training shall be the right of all holders of a doctor's, masters and bachelor's degree working in the national healthcare system.
(2) Post-graduate training shall include:
1. the training for acquisition of a specialty in healthcare;
2. (amended, SG No. 85/2005) continuing medical training.
(3) The Minister of Health shall specify the number of places for post-graduate training in specialties subsidized by the government in conformity with the objectives and priorities of the national health strategy on an annual basis.
Article 179
The Minister of Health shall plan and coordinate the activities related to the post-graduate training for the acquisition of a specialty by medical and non-medical specialists working in the national healthcare system.
Article 180
(1) The theoretical training under Article 178, Paragraph 2, and Item 1 shall be conducted by:
1. higher schools accredited with positive assessment under the Higher Education Act and the Military Medical Academy;
2. national centres for public health affairs accredited for the respective specialty under the Higher Education Act.
(2) The practical training under Article 178, Paragraph 2, and Item 1 shall be conducted by:
1. the establishments under Paragraph 1;
2. medical establishments accredited with positive assessment for training of students and post-graduates.
(3) Specialty shall be acquired upon the completion of training programmes and successful sitting for a practical and theoretical examination before a state examination panel appointed at an order of the Minister of health.
Article 181
(1) The list of basic and profiled specialties in the healthcare system and the terms and conditions for conducting training and acquiring a specialty in healthcare, as well as financial matters, shall be set out in an ordinance issued by the Minister of Health in consultation with the Minister of Education and Science and the Minister of Finance.
(2) The funding of the training for acquiring a specialty in healthcare shall be determined in conformity with the objectives and priorities of the national health strategy.
Article 182
(1) (Amended, SG No. 85/2005, SG No. 75/2006) Doctors', dentists', master pharmacists', nurses, midwives and associated medical specialists professional organisations shall organise, coordinate, conduct and register the continuing medical education of medical doctors, dentists, master pharmacists, nurses, midwives and associated medical specialists under terms and by a procedure set out in agreements with the higher schools, the Bulgarian Red Cross and the Military Medical Academy.
(2) (Amended, SG No. 85/2005) Higher schools, the Military Medical Academy, medical colleges, the Bulgarian Red Cross Society and other associations of people working in healthcare shall conduct the continued medical training of specialists in the healthcare system other than those under Paragraph 1 under terms and conditions set out in agreements with the post-graduate training facilities.
(3) (Amended, SG No. 85/2005, SG No. 75/2006) The Union of Scientific Medical Societies in Bulgaria, the Union of Scientists in Bulgaria and medical associations by specialties may engage in the conduct of continuing medical training of medical doctors, doctors of dental medicine and master pharmacists under terms and conditions set out in agreements with the Bulgarian Doctors' Union, the Union of Dentists in Bulgaria and Union of Pharmacists in Bulgaria.
(4) The activities under Paragraphs (1) to (3) shall be subject to control under terms and conditions set out by the Minister of Health.

Section II
Medical Profession
Article 183
(1) (Amended, SG No. 85/2005) The medical profession shall be practiced by persons who hold a diploma for completed higher education in specialities from the occupational sections of medicine, dentistry, pharmacology and health care.
(2) (New, SG No. 85/2005) The diploma referred to in Paragraph 1 shall attest to the higher education acquired in the respective specialty and educational qualification degree, as well as to the professional qualification as set down in the state requirements pursuant to Article 177.
(3) (Renumbered from Paragraph (2), SG No. 85/2005) Medical doctors and doctors of dental medicine shall practice the medical profession under the conditions of Paragraph 1 and Article 3 (1) of the Doctors' and Doctors of Dental Medicine Professional Organisations Act.
(4) (New, SG No. 85/2005) Professional Organisation of Medical Nurses, Midwives and Associated Medical Specialists Guild Act.
(5) (New, SG No. 75/2006) Master pharmacists shall practice the medical profession under the conditions of Paragraph (1) and Article 3 (1) of the Professional Organisation of Masters of Pharmacy Act.
Article 184
(Repealed, SG No. 85/2005)
Article 185
(1) (Amended, SG No. 85/2005) The Ministry of Health shall officially establish and maintain a list of persons who have acquired higher education in specialties from the professional field of medicine, dentistry, pharmacology, public health and health care.
(2) (Repealed, renumbered from Paragraph (4), amended, SG No. 85/2005) The data in the list shall be accessible for use to all persons under the Access to Public Information Act.
(3) (Repealed, SG No. 85/2005)
Article 186
(Amended, SG No. 85/2005)
(1) (+mended, SG No. 13/2008) Citizens of a European Union member state, the other states from the European economic community and Switzerland shall practice the medical profession in the Republic of Bulgaria after recognition of the professional qualifications thereof according to the procedure established by the Recognition of Professional Qualifications Act.
(2) The Ministry of Health and the higher educational establishments shall provide the persons referred to in Paragraph (1) conditions for the acquisition of the necessary linguistic knowledge and professional terminology in Bulgarian for practicing their profession in the Republic of Bulgaria when the need arises and when this is in their interest and in the interest of their patients.
(3) (Amended, SG No. 59/2006, SG No. 13/2008) Foreigners other than those referred to in Paragraph (1) shall practice the medical profession in the Republic of Bulgaria after recognition of the professional qualifications thereof according to the procedure established by the Recognition of Professional Qualifications Act, and if they have a command of the Bulgarian language and professional terminology in Bulgarian, determined in pursuance to Regulations of the Minister of Education and Science and the Minister of Health.
(4) In the cases other than those under Paragraphs (1) - (3), the right to practice the medical profession shall be granted also to foreigners invited for scientific exchange between medical establishments under terms and conditions set out in an ordinance issued by the Minister of Health.
(5) (Repealed, SG No. 13/2008).
Article 187
(Repealed, SG No. 85/2005)
Article 188
(Amended, SG No. 85/2005)
The Minister of Health shall issue an ordinance to specify the professional competence of persons working in the national healthcare system who are holders of a higher education diploma in the specialties of psychology, kinesitherapy, biology, biochemistry, microbiology and molecular biology.
Article 189
Medical establishments shall insure the persons exercising the medical profession at the medical establishment for potential damages resulting from culpable non-performance of their professional duties.
Article 190
(1) Persons exercising the medical profession shall be free to act and make decisions in accordance with their professional qualifications, medical standards and medical ethics.
(2) Medical specialists and medical establishments may not use commercial advertising for their activities.
Article 191
(1) (Amended, SG No. 85/2005, 59/2006) A medical specialist - A medical specialist - Bulgarian citizen, foreigner or a citizen of a European Union member-state, the other states from the European economic space or Switzerland, permanently residing in the Republic of Bulgaria who has not occupied a position or performed an activity requiring professional qualification in a medical profession for more than five years shall lose the right to practice that medical profession.
(2) (New, SG No. 85/2005, amended, SG No. 59/2006) The persons with professional qualification in a medical profession who hold positions or operate in the field of public health care shall not lose their right to practice the medical profession in case of continuous training and practicing the profession.
(3) (Renumbered from Paragraph (2), amended, SG No. 85/2005) The persons under Paragraph (1) shall restore their rights following an examination under conditions and by a procedure established by an ordinance issued by the Minister of Health.
Article 192
(1) Medical specialists may not exercise their profession if they suffer of diseases threatening the health and life of patients.
(2) The list of diseases under Paragraph 1 shall be determined by the Minister of Health.
(3) In the cases under Paragraph 1, the Minister of Health shall issue an order to delete the medical specialist from the register under Article 185.
(4) The order of the Minister of Health shall be subject to appeal under the Administrative Procedure Code.
Article 193
(1) The Minister of Health may issue an order to withdraw the right of a person to exercise the medical profession in the Republic of Bulgaria for a term ranging from six months to two years in any of the following cases:
1. repeated violation of the established medical standards;
2. repeated violation of the principles and procedure for conducting medical expert activities to establish the ability to work.
(2) The order under Paragraph 1 shall be subject to appeal under the Administrative Procedure Code.

Section III
(Repealed, SG No. 13/2008)
Recognition of Professional Qualification in Medical Profession
(Title amended, SG No. 59/2006)
Article 194
(Amended and supplemented, SG No. 85/2005, No. 59/2006,
repealed, No. 13/2008)
Article 195
(Supplemented, SG No. 85/2005, amended and supplemented,
No. 59/2006, repealed, No. 13/2008)
Article 196
(Repealed, SG No. 59/2006)

Section IV
Medical Research on People. Medical Science
Article 197
(1) The Ministry of Health shall organise and control the conduct of medical research on people.
(2) Medical research, within the meaning of this Act, is any experiment on people conducted with a view to increasing medical knowledge.
(3) Tested persons shall have all the rights of a patient.
(4) Medical research shall be conducted, while ensuring maximum safety for the health of the tested person and non disclosing his/her personal data.
(5) The interests of the tested person shall prevail over the scientific and financial interests of the researcher at any stage of the medical research.
Article 198
(1) Medical research on people shall not be conducted in any of the following cases:
1. it contravenes the law or medical ethics;
2. no evidence has been produced on their safety;
3. no evidence has been produced on the expected scientific benefits;
4. it does not correspond to the scientific objective and the medical research plan;
5. there is an increased risk for the health and life of the tested person.
(2) No medical research on people shall be conducted with chemical substances and physical sources of radiation which may lead to changes of the human genome.
(3) No medical research on people shall be conducted with products of genetic engineering which may lead to the transmission of new properties of the progeny.
Article 199
(1) Medical research shall be conducted only on persons who have given their informed consent in writing upon their notification in writing by the leader of the research on the essence, importance, scope and possible risks of the research.
(2) Consent with the participation in medical research shall be given only by a legally capable person understanding the essence, importance, scope and possible risks of the clinical tests.
(3) The consent shall be given in person and in writing. It may be withdrawn at any point of time.
Article 200
(1) No medical research shall be conducted on people put under legal incapacity.
(2) Where no significant health benefits are expected, medical research shall not be conducted on:
1. pregnant women and breast-feeding mothers;
2. prisoners;
3. (repealed, SG No. 46/2007, effective 1.01.2008).
Article 201
(1) All persons subjected to medical research shall be insured against damage to their health or death.
(2) The general terms and conditions, the minimum insurance amount, the minimum insurance premium and the insurance procedure under Paragraph 1 shall be set out in an ordinance issued by the Council of Ministers.
Article 202
(1) The leader of the medical research shall be a medical doctor or a doctor of dental medicine with recognised medical specialty and shall be responsible for the planning and conduct of the research.
(2) Medical research on people shall be conducted only by qualified specialists with higher education in the field of medicine, dental medicine, pharmacology, biology and biochemistry.
(3) Medical research may be conducted by foreign persons only on the basis of an agreement consulted with the Minister of Health.
Article 203
(1) Medical research shall be conducted upon obtaining a positive opinion from the local commission for ethics set up at the medical establishment or research organisation conducting the medical research.
(2) The membership of the commission under Paragraph 1 shall be determined by the head of the establishment or organisation.
(3) Specialists involved in the preparation, organisation and conduct of the research may not sit on the commission under Paragraph 1.
(4) The local commission for ethics shall give its opinion within 30 days of receipt of the request by the leader of the research.
(5) The local commission for ethics shall supervise the conduct of medical research on people, on which it has given a positive opinion.
Article 204
Upon the completion of the medical research on people, the leader of the research shall inform the local commission for ethics within 30 days.
Article 205
(1) The medical research may be terminated at any point of time in any of the following cases:
1. withdrawal of the consent of the tested person;
2. at the proposal of the leader of the research;
3. at the proposal of the chairperson of the local commission for ethics at the medical or healthcare establishment in the event of proven violations in the course of its conduct.
(2) Upon the termination of the medical research under Paragraph 1, Items 1 and 2, the leader of the research shall inform the local commission for ethics within 15 days.
Article 206
The terms and conditions for the conduct of medical research shall be set out in an ordinance issued by the Minister of Health in consultation with the Minister of Education and Science.
Article 207
The Minister of Health shall determine, on an annual basis, research projects in the government research priorities in the field of medicine at the proposal of the rectors of higher schools, the directors of the national centres for public health affairs, heads of research organisations and other legal entities and upon obtaining the opinion of the Supreme Medical Council.
Article 208
(1) The Minister of Health shall announce a competition to select contractors of research projects in the government research priorities.
(2) The terms and conditions for the conduct of competitions and the requirements to the applicants shall be set out in an ordinance issued by the Minister of Health in consultation with the Minister of Education and Science.
(3) Research projects shall be financed through government subsidies and other sources.


Chapter Eight
ADMINISTRATIVE PENALTY PROVISIONS
Article 209
(1) Persons failing to appear for a compulsory preventive medical examination, test or immunization shall be punished with a fine ranging from BGN 50 to BGN 100 or from BGN 100 to BGN 200 in the case of repeated failure to appear.
(2) The penalties under Paragraph 1 shall be imposed also on officials who have prevented persons to appear for a compulsory preventive medical examination, test or immunization.
Parents or trustees failing to ensure the compulsory immunization of their children shall be punished with a fine ranging from BGN 50 to BGN 100. The fine shall range from BGN 100 to BGN 200 in the case of repeated violation.
Article 210
(1) Persons engaging in activities in violation of the health requirements under this Act and the related secondary legislation shall be punished with a fine ranging from BGN 200 to BGN 5,000 or from BGN 3,000 to BGN 10,000 in the case of repeated violation.
(2) Where the violation under Paragraph 1 has been committed by a sole proprietor, a pecuniary sanction shall be imposed, ranging from BGN 100 to BGN 1,500 or from BGN 3,000 to BGN 9,000 in the case of repeated violation.
(2) Where the violation under Paragraph 1 has been committed by a legal entity, a pecuniary sanction shall be imposed, ranging from BGN 2,000 to BGN 5,000 or from BGN 6,000 to BGN 12,000 in the case of repeated violation.
Article 211
(1) Persons engaging in activities in a facility for public use without fulfilling the obligation to advise RIPHPC thereof shall be punished with a fine ranging from BGN 1,000 to BGN 3,000 or from BGN 3,000 to BGN 10,000 in the case of repeated violation.
(2) Where the violation under Paragraph 1 has been committed by a sole proprietor, a pecuniary sanction shall be imposed, ranging from BGN 3,000 to BGN 9,000 or from BGN 9,000 to BGN 15,000 in the case of repeated violation.
(3) Where the violation under Paragraph 1 has been committed by a legal entity, a pecuniary sanction shall be imposed, ranging from BGN 5,000 to BGN 15,000 or from BGN 10,000 to BGN 20,000 in the case of repeated violation.
Article 212
(1) Persons refusing or obstructing the exercise of state health control or the taking of samples by the state health control authorities shall be punished with a fine ranging from BGN 500 to BGN 1,000 or from BGN 1,000 to BGN 1,500 in the case of repeated violation, unless a more severe punishment is due.
(2) Persons failing to fulfil the instructions of the state health control authorities shall be punished with a fine ranging from BGN 500 to BGN 1,000 or from BGN 1,000 to BGN 1,500 in the case of repeated violation, unless a more severe punishment is due.
(3) Where the violation under Paragraphs (1) and (2) has been committed by a sole proprietor or a legal entity, a pecuniary sanction shall be imposed, ranging from BGN 500 to BGN 1,000 or from BGN 1,000 to BGN 1,500 in the case of repeated violation.
Article 213
(2) Persons failing to fulfil the instructions to discontinue the operation of facilities or violating a prohibition to sell products and goods as instructed by the state health control authorities shall be punished with a fine ranging from BGN 3,000 to BGN 9,000 or from BGN 10,000 to BGN 30,000 in the case of repeated violation, unless a more severe punishment is due.
(2) Where the violation under Paragraph 1 has been committed by a sole proprietor, a pecuniary sanction shall be imposed, ranging from BGN 2,000 to BGN 6,000 or from BGN 6,000 to BGN 12,000 in the case of repeated violation.
(3) Where the violation under Paragraph 1 has been committed by a legal entity, a pecuniary sanction shall be imposed, ranging from BGN 5,000 to BGN 15,000 or from BGN 15,000 to BGN 30,000 in the case of repeated violation.
Article 214
(1) (Amended, SG No. 59/2006, effective 21.07.2006) Persons engaging in unauthorised activities for the demolishing or removal of asbestos and/or asbestos-containing materials of buildings, structures, enterprises, installations or vessels without having received the permit referred to in Article 73 herein shall be punished with a fine of up to BGN 1,500 or ranging from BGN 1,500 to BGN 3,000 in the case of repeated violation.
(2) Where the violation under Paragraph 1 has been committed by a sole proprietor, a pecuniary sanction shall be imposed, ranging from BGN 500 to BGN 1,500 or from BGN 1,500 to BGN 5,000 in the case of repeated violation.
(3) Where the violation under Paragraph 1 has been committed by a legal entity, a pecuniary sanction shall be imposed, ranging from BGN 1,000 to BGN 3,000 or from BGN 3,000 to BGN 6,000 in the case of repeated violation.
Article 215
Persons with infectious diseases under Art, 61 refusing mandatory isolation and treatment shall be punished with a fine ranging from BGN 50 to BGN 500. Persons refusing to come voluntarily for isolation and treatment shall be brought forcibly with the assistance of the authorities of the Ministry of Interior at the request of the head of the medical establishment for hospital aid.
Article 216
Medical specialists violating the terms and conditions for registration, notification and reporting, as well as the terms and conditions for isolation, testing and dispensary registration of patients, former patients, infection carriers and persons in contact with them shall be punished with a fine ranging from BGN 300 to BGN 1,000 and with withdrawal of the right to exercise the medical profession for a term ranging from six months to a year in the case of repeated violation.
Article 217
(1) Persons engaging in activities for disinfection, disinfection and deratization in violation of the requirements under this Act and the related secondary legislation shall be punished with a fine ranging from BGN 500 to BGN 1,500 or from BGN 1,500 to BGN 3,000 in the case of repeated violation.
(2) Where the violation under Paragraph 1 has been committed by a sole proprietor, a pecuniary sanction shall be imposed, ranging from BGN 300 to BGN 1,000 or from BGN 1,000 to BGN 3,000 in the case of repeated violation.
(3) Where the violation under Paragraph 1 has been committed by a legal entity, a pecuniary sanction shall be imposed, ranging from BGN 500 to BGN 1,500 or from BGN 1,500 to BGN 5,000 in the case of repeated violation.
Article 218
(1) Persons violating the provisions of Arts. 54 or 56 shall be punished with a fine ranging from BGN 50 to BGN 100 or from BGN 100 to BGN 300 in the case of repeated violation.
(2) (Supplemented, SG No. 59/2006) The pecuniary sanction for violations under Articles 54 and 56 committed by legal entities shall range from BGN 500 to BGN 1,500 and from BGN 3,000 to BGN 10,000 in the case of repeated violation.
(3) Persons advertising alcoholic beverages in violation of Article 55, pares 1 and 2 shall be punished with a fine ranging from BGN 500 to BGN 1,500 or from BGN 1,500 to BGN 5,000 in the case of repeated violation.
(4) Where the violation under Paragraph 3 has been committed by a sole proprietor, a pecuniary sanction shall be imposed, ranging from BGN 300 to BGN 1,000 or from BGN 1,000 to BGN 3,000 in the case of repeated violation.
(5) Where the violation under Paragraph 3 has been committed by a legal entity, a pecuniary sanction shall be imposed, ranging from BGN 500 to BGN 1,500 or from BGN 1,500 to BGN 5,000 in the case of repeated violation.
(6) Radio and television operators broadcasting advertisement of alcoholic beverages in violation of Article 55, Paragraphs 1 and 3 shall be punished with a pecuniary sanction of BGN 5,000 or BGN 10,000 in the case of repeated violation as imposed by the Council for Electronic Media under the Radio and Television Act.
(6) Radio and television operators broadcasting advertisement of spirits in violation of Article 55, Paragraph 2 shall be punished pursuant to the Radio and Television Act.
Article 219
(1) Persons engaging in activities with sources of ionizing radiation in violation of the requirements under this Act and the related secondary legislation shall be punished with a fine ranging from BGN 2,000 to BGN 5,000 or from BGN 5,000 to BGN 15,000 in the case of repeated violation.
(2) Where the violation under Paragraph 1 has been committed by a sole proprietor, a pecuniary sanction shall be imposed, ranging from BGN 1,000 to BGN 3,000 or from BGN 3,000 to BGN 10,000 in the case of repeated violation.
(3) Where the violation under Paragraph 1 has been committed by a legal entity, a pecuniary sanction shall be imposed, ranging from BGN 1,500 to BGN 5,000 or from BGN 5,000 to BGN 15,000 in the case of repeated violation.
Article 220
(1) Officials failing to inform the patient of the circumstances under Article 88, Paragraph 1 shall be punished with a fine ranging from BGN 300 to BGN 1,000 and with withdrawal of the right to exercise the medical profession for a term ranging from six months to a year in the case of repeated violation.
(2) Persons providing medical aid without the informed consent of the patient or in violation of the requirements for obtaining the informed consent of the patient shall be punished with a fine ranging from BGN 500 to BGN 1,500 and with withdrawal of the right to exercise the medical profession for a term ranging from six months to a year in the case of repeated violation.
(3) Officials disclosing health information beyond the provisions of this Act and the related secondary legislation shall be punished with a fine ranging from BGN 500 to BGN 1,500 or from BGN 2,000 to BGN 6,000 in the case of repeated violation, unless a more severe punishment is due.
Article 221
Persons violating of rights of a patient under this Act and the related secondary legislation shall be punished with a fine ranging from BGN 300 to BGN 1,000 or from BGN 500 to BGN 1,500 in the case of repeated violation.
Article 222
(1) (Amended, SG No. 85/2005, No. 59/2006) Persons providing medical aid or engaging in healthcare activities without having the necessary professional qualification in a medical profession required shall be punished with a fine ranging from BGN 5,000 to BGN 10,000 or from BGN 10,000 to BGN 20,000 in the case of repeated violation, unless a more severe punishment is due.
(2) Medical specialists committing recurrent violations in the course of exercising the medical profession due to negligence or ignorance, committing gross mistakes in the job or engaging in immoral actions abusing with their official position shall be punished with withdrawal of the right to exercise the medical profession for a term ranging from three months to two years, unless a more severe punishment is due.
(3) Medical doctors, doctors of dental medicine, nurses, midwives or paramedics refusing to provide urgent medical aid to a person in critical condition shall be punished with a fine ranging from BGN 1,000 to BGN 5,000 and with withdrawal of the right to exercise the medical profession for a term ranging from three months to a year in the case of repeated violation.
Article 223
(Amended, SG No. 71/2006)
(1) Persons engaging in assisted reproduction in violation of Articles 130, 131, 132a, 132b, 133, 135 and 136 shall be punished with a fine of BGN 15,000 or exceeding this sum but not exceeding BGN 50,000 and with withdrawal of the right to exercise the medical profession for a term ranging from three months to a year in the case of repeated violation, unless a more severe punishment is due.
(2) Persons who violate the provision of Article 132 shall be punished with a fine of BGN 5,000 or exceeding this sum but not exceeding BGN 10,000 and a pecuniary sanction of BGN 20,000 or exceeding this sum but not exceeding BGN 50,000 shall be imposed in cases where the violation is perpetrated by a legal person.
(3) Persons who violate the provision of Article 134 shall be punished with a fine of BGN 25,000 or exceeding this sum but not exceeding BGN 50,000 and a pecuniary sanction of BGN 50,000 or exceeding this sum but not exceeding BGN 100,000 shall be imposed in cases where the violation is perpetrated by a legal person.
Article 224
Officials imposing physical constraint measures to a patient with established mental disorders in violation of the requirements of this Act and the related secondary legislation shall be punished with a fine ranging from BGN 500 to BGN 1,500 and with withdrawal of the right to exercise the medical profession for a term ranging from three months to a year in the case of repeated violation, unless a more severe punishment is due.
Article 225
(1) Medical specialists issuing sickness certificates in violation of the existing statutory requirements shall be punished with a fine ranging from BGN 1,000 to BGN 3,000 or from BGN 4,000 to BGN 10,000 in the case of repeated violation.
(2) Officials failing to fulfil the order of the director of the regional healthcare centre to set up a physician consultative commission shall be punished with a fine ranging from BGN 500 to BGN 1,500 or from BGN 1,500 to BGN 4,500 in the case of repeated violation.
Article 226
Persons engaging in medical research in violation of this Act shall be punished with a fine ranging from BGN 2,000 to BGN 6,000 and with withdrawal of the right to exercise the medical profession for a term ranging from three months to a year in the case of repeated violation, unless a more severe punishment is due.
Article 227
Persons practising non-conventional methods of impact on individual health in violation of the requirements of this Act and the related secondary legislation shall be punished with a fine ranging from BGN 500 to BGN 1,500 or from BGN 1,500 to BGN 5,000 in the case of repeated violation.
Article 228
Medical specialists violating the requirements under this Act and the related secondary legislation to the form, content, terms and conditions for the use, processing, analysis, storage and disclosure of medical documentation shall be punished with a fine ranging from BGN 500 to BGN 1,500 or from BGN 1,500 to BGN 3,000 in the case of repeated violation.
Article 229
(1) Persons violating the requirements under this Act and the related secondary legislation in the cases other than those under Arts. 209 to 228 shall be punished with a fine ranging from BGN 200 to BGN 600 or from BGN 1,000 to BGN 3,000 in the case of repeated violation.
(2) Where the violation under Paragraph 1 has been committed by a sole proprietor, a pecuniary sanction shall be imposed, ranging from BGN 200 to BGN 600 or from BGN 600 to BGN 2,000 in the case of repeated violation.
(3) Where the violation under Paragraph 1 has been committed by a legal entity, a pecuniary sanction shall be imposed, ranging from BGN 500 to BGN 2,000 or from BGN 2,000 to BGN 5,000 in the case of repeated violation.
Article 229a
(New, SG No. 71/2006)
The violations referred to in Articles 130, 131, 132, 132a, 132b, 133, 135 and 136 shall be established by memoranda compiled by officials from the Executive Agency of Transplantation appointed by the director thereof, and the penalty orders shall be issued by the Minister of Health or by an official authorized thereby.
Article 229b
(New, SG No. 71/2006)
The violations referred to in Article 134 shall be established by memoranda compiled by the customs authorities or by officials from the Executive Agency of Transplantation appointed by the director thereof, and the penalty orders shall be issued by the Director of the Customs Agency or persons appointed thereby, respectively by the Minister of Health or by an official authorised thereby.
Article 230
(1) The violations under Arts. 225 and 227 shall be established with statements of findings by officials designated by the RHC director and penalty orders shall be issued by the RHC director.
(2) A copy of the penalty order issued for violations under Paragraph 1 shall be send to the higher-standing medical expert body for assessment of the ability to work, to the regional council for control of the acts issued by the medical expert bodies for assessment of the temporary loss of the ability to work, to the parties concerned (assessed persons, insurers and the National Insurance Institute) and RHIF.
Article 231
The violations under Arts. 210 to 217 and 218, pares 1, 2, 3, 4 and 5 shall be established with statements of findings by state health inspectors and penalty orders shall be issued by the RIPHPC director.
Article 232
The violations under Arts. 209, 215 and 217 shall be established with statements of findings by officials designated by the RHC director or by state health inspectors and penalty orders shall be issued by the RHC or RIPHPC director respectively.
Article 233
The violations under Article 219 shall be established with statements of findings by state health inspectors or by officials designated by the NCRRP director and penalty orders shall be issued by the RIPHPC or NCRRP director respectively.
Article 234
The violations under Arts. 220 to 228 shall be established with statements of findings by officials designated by the Minister of Health or RHC director and penalty orders shall be issued by Minister of Health or a person designated by the Minister or by the RHC director.
Article 235
The violations under Article 229 shall be established with statements of findings by officials designated by the Minister of Health or RHC director or by state health inspectors and penalty orders shall be issued by Minister of Health, the RHC director or the RIPHPC director, depending on their competence.
Article 236
The drawing up of statements of findings and the issuance, appeal and enforcement of penalty orders shall be performed pursuant to the provisions of the Administrative Violations and Sanctions Act.


ADDITIONAL PROVISION
§ 1. Within the meaning of this Act:
1. "Health documentation" is all forms of registration and storage of health information;
2. "Dispensary registration" is a method of active search for and diagnostics, treatment and regular monitoring of patients with specific diseases.
3. "Invasive methods" and diagnostic and therapeutic instrumental methods of penetration into the human body by means of severing of the skin and mucous membranes or through natural openings.
4. "Medical legal procedures" are procedures applied with a view to protecting the security of the country, the internal order or the health of citizens without any medical indications.
5. "Repeated violation" is a violation committed within a year of the effective date of the penalty order imposing a penalty for a violation of the same type.
6. "Screening" is a targeted preventive test within the framework of a specific programme to detect the spread of a certain sign, symptom or disease among a group of individuals.
7. "Physical constraint" is the application of mechanical means for immobilization, forced isolation in special closed premises and use of pharmaceuticals to reduce the physical activity of a patient, where the latter is a threat to himself/herself or the people around him/her.
8. "Health promotion" is a process, in which social, economic, environmental and other conditions are created and adequate health education is provided in order to enable individuals to improve their own health through enhanced individual and group responsibility.
9. "Facilities for public use" are:
(a) water sources and mineral water sources, water supply facilities, installations and networks for supply of drinking water to households;
(b) swimming pools, beaches, baths;
(c) (amended, SG No. 94/2005) sheltering facilities - hotels, motels, villa sites and tourist holiday villages, accommodation facilities boarding houses, holiday houses, family hotels, separate rooms, villas, houses, bungalows, camping sites, as well as tourist mountain lodges, tourist training centres and tourist dormitories;
(d) sports facilities - stadiums, sports halls, playgrounds, fitness centres and halls;
(e) theatre halls, cinema halls, concerts halls, computer and Internet halls, game halls;
(f) barbers' shops, hairdressers' and beauty salons, public baths, launderettes, saunas, public WC;
(g) cemetery parks;
(h) (supplemented, SG No. 81/2006, amended, SG No. 46/2007, effective 12.06.2007) enterprises for the production of and wholesale trade in medicinal products and medical devices, pharmacies, drugstores and opticians shops;
(i) enterprises for the production and storage of and trade in cosmetic products;
(j) railway stations, airports, ports, bus stations, underground stations;
(k) petrol and gas stations;
(l) public transport vehicles - trains, aircraft, ships, buses, trams, trolleybuses, underground trams, special vehicles - sanitary vehicles for patients, medicines and consumables, food transporting vehicles, hearses;
(m) (supplemented, SG No. 94/2005) enterprises for production, storage of and trade in foods, public catering and entertainment outlets, as well as catering facilities, belonging to tourist lodges - tourist canteens, tourist buffets and tourist canteens with waiter services);
(n) crèches and kindergartens and social establishments for children and students, schools and higher schools, student hostels, schools in music, foreign languages and sports, and centres for work with children;
(o) (amended, SG No. 59/2006) medical and healthcare establishments, health offices;
(p) (repealed, SG No. 59/2006) ;
(q) sites with sources of ionizing radiation;
(r) (repealed, SG No. 82/2007) ;
(s) agricultural pharmacies.
10. "Products and goods of importance for human health" are:
(a) foods, food additives, materials and objects designed for contact with food;
(b) pharmaceuticals;
(c) cosmetic products;
(d) chemical substances, preparations and products;
(e) second-hand clothes.
11. "Activities of importance for human health" are:
(a) urban planning and development;
(b) the design, construction, reconstruction, extension and commissioning of housing units and facilities for public use;
(c) cleaning of settlements in municipalities;
(d) the implementation of the immunization calendar of the Republic of Bulgaria;
(e) the prevention and restriction of internal hospital infections at medical establishments;
(f) the implementation of disinfection, pest control of insects and rodents;
(g) the preparation and observance of weekly school programmes;
(h) the observance of physiological standards for the organised nutrition of groups of the population.
(i) (new, SG No. 59/2006) the activity of the services on labour medicine;
(j) (new, SG No. 59/2006) activity with hazardous waste.
12. "Environmental factors" are:
(a) drinking water and water for household purposes;
(b) water for bathing;
(c) mineral water for drinking or use for preventive, therapeutic or sanitary purposes;
(d) noise and vibrations in housing and public buildings and urban areas;
(e) ionizing radiation in housing, industrial and public buildings;
(f) non-ionizing radiation in housing, industrial and public buildings;
(g) chemical factors and biological agents in facilities for public use;
(h) resort resources;
(i) air.
13. "Urban areas" are settlements and communities within building boundaries set out in a specific development plan.
14. "Cosmetic product" is any substance or preparation for contact with the various external parts of the human body - skin (epidermis), hair, nails, lips and external genitals - or with the teeth and mucous membrane of the stoma exclusively or primarily for the purposes of their cleaning, perfuming, change of appearance and/or correction of odours and/or protection and maintenance in good shape.
15. "Informed consent" is the consent given voluntarily after becoming aware of specific information.
16. "reproductive health" is the health of people in connection with their ability to have progeny.
17. "Alcoholic beverages" are spirits, wine and beer.
18. "Spirits" are liquids for consumption with at least 15 volumetric percent of ethyl alcohol.
19. "Direct advertising" is any form of a commercial message, communication or recommendation aimed at promoting alcoholic beverages and/or their consumption through the use of the beverages themselves or actions related to their consumption, production and distribution.
20. "Indirect advertising" is any form of a commercial message, communication, recommendation or action using a brand or trademark of an alcoholic beverage, as well as the name of brand of a producer of alcoholic beverages on products and goods which are not alcoholic beverages.
21. "Assisted reproduction" is the set of diagnostic and therapeutic methods intended to overcome sterility, which are applied at specialised centres.
22. "Dietetics" is a curative method by means of which a prescribed nutrition regime, including the one only with fruit, vegetables or other products of organic origin, leads to favourable impact on individual health.
23. "Curative hunger" is a curative method by means of which a prescribed regime of water, juices or other liquids intake leads to favourable impact on individual health.
24. (New, SG No. 71/2006) "Ovum" is a female reproductive cell.
25. (New, SG No. 71/2006) "Spermatozoids" are the male reproductive cells.
26. (New, SG No. 71/2006) "Zygote" is a fertilized ovum in the stage of division.
27. (New, SG No. 71/2006) "Extraction" is the extraction of ova by medical methods or the collection of spermatozoids from a donor, which is done with the objective of assisted reproduction or for other scientific and educational needs of medicine.
28. (New, SG No. 71/2006) "Insertion" is the placement by medical methods of spermatozoids, an ovum or a zygote in the body of a woman.
29. (New, SG No. 71/2006) "Expert opinion: is an activity related to tests for assessing the condition of an ovum, spermatozoids or a zygote, as well as for establishing the existence of pathogenic organisms, chemical or biological substances through which an illness, infection or intoxication may be transmitted.
30. (New, SG No. 71/2006) "Processing" is an activity for preparation of an ovum, spermatozoids or a zygote for placement by the application of physical, chemical or biological methods, in the course of extraction or directly after that, including the packaging thereof, at which no change to their integrity takes place.
31. (New, SG No. 71/2006) "Storage" is an activity related to the application of physical or chemical processes, or change to the environment, for the prevention or delay of the biological or physical damage of the extracted ova, spermatozoids or zygotes, including the packaging thereof.
32. (New, SG No. 71/2006) "Donor" is every source of cells of human origin.
33. (New, SG No. 71/2006) "Labelling" is an activity on designation of the packaging of organs, tissues and cells with the objective of identification thereof.


TRANSITIONAL AND FINAL PROVISIONS
§ 2. (1) The persons authorised to practise the medical profession under the repealed Public Health Act are legally competent medical specialists within the meaning of Article 184.
(2) The Minister of Health shall issue an ordinance on the entry of the persons under Paragraph 2 in the register under Article 185.
§ 2a. (New, SG No. 76/2005) (1) The persons who have acquired the educational qualification degree "Master" for the profession "Dentistry" have the rights of the persons who have acquired the educational qualification degree "Master" in "Dental Medicine".
(2) The Health Minister issues a document with which it certifies the rights of the persons under Paragraph 1.
§ 2b. (New, SG No. 59/2007) (1) The persons who have rights under –∑ 32, Paragraphs (2) and (3) of the Transitional and Final Provisions of the Act to Amend and Supplement the Higher Education Act (Promulgated SG No. 41/2007) shall enjoy the rights of persons who have acquired a bachelors degree under Article 42, Paragraph (1), Item 1(b) of the Higher Education Act to practice the profession provided that they have practised it for at least three years in succession during the past 5 years in the case of nurses, or for at least two years in succession during the past 5 years in the case of midwives.
(2) The persons who do not meet the experience requirements of Paragraph (1) shall enjoy the rights of persons who have acquired a bachelor's degree under Article 42, Paragraph (1), and Item 1(b) of the Higher Education Act to practice the profession after they gain the required experience.
§ 3. The persons who were given a deadline for the degree of the long- term loss of their ability to work as of 31 December 2004 shall be considered to have an established extent of the long-term loss of their ability to work for life upon becoming 65 years of age.
§ 4. (1) Within a month of the effective date of this Act, the Council of Ministers shall re-organise the existing district healthcare centres into regional healthcare centres and the existing inspectorates for hygiene and epidemiology into regional inspectorates for public health protection and control.
(2) Within a month of the effective date of the ordinance under Paragraph 1, the Minister of Health shall issue Regulations on the Structure and Activities of Regional Healthcare Centres and Regulations on the Structure and Activities of Regional Inspectorates for Public Health Protection and Control.
(3) The persons exercising the state sanitary control at the inspectorates for hygiene and epidemiology as of the effective date of this Act, shall have the rights laid down in § 3 of the Transitional and Final Provisions of the Civil Servants Act.
(4) Regional inspectorates for health protection and control may conclude contracts with the NHIF until 31 December 2005.
§ 5. This Act shall repeal the Public Health Act (Promulgated SG No. 88/1973; Emended SG No. 92/1973; Amended SG Nos. 63/1976, 28/1983, 66/1985, 27/1986, 89/1988, 87 and 99/1989, 15/1991; Emended SG No. 24/1991; Amended SG Nos. 64/1993, 31/1994, 36/1995, 12, 87 and 124/1997, 21, 70, 71 and 93/1998, 30, 62, 67, 90 and 113/1999, 10 and 36/2000, 63/2002, 83 and 102/2003.
§ 6. In Article 52, Paragraph 2 of the Carriage by Road Act (Promulgated SG No. 82/1999; Amended SG Nos. 11 and 45/2002 and 99/2003), the word "sanitary" shall be replaced by the words "state health control authorities".
§ 7. The Safe Use of Nuclear Energy Act (Promulgated SG No. 63/2002; Amended SG No. 120/2002) shall be amended as follows:
1. In Article 15:
(a) Paragraph 3, Item 6 is repealed;
(b) Paragraph 4, Item 8 is repealed;
2. Article 18, Paragraph 1, Item 3 is amended as follows:
"3. under Article 15, Paragraph 3, Items 2 to 5 - within a month";
3. In Art, 29:
(a) the current wording becomes Paragraph 1;
(b) a new Paragraph 2 is inserted as follows:
"(2) No fee shall be payable for the issuance of an authorization to import or export sources of ionizing radiation or parts thereof."
4. In Article 31:
(a) a new Paragraph 2 is inserted as follows:
"(2) The initial licensing fee for the issuance of a license to use radioactive substances and other sources of ionizing radiation for medical purposes and the annual licensing fees shall be equal to 50 percent of the fees set out in Article 28, Paragraph 1."
(b) the current Paragraph 2 becomes Paragraph 3;
5. Article 57, Paragraph 1 is repealed;
6. In Article 58:
(a) Paragraph 1, Item 5 is repealed;
(b) In Paragraph 3, the words "of three" shall be inserted after the words "for a term";
7. Article 59 is amended as follows:
"Article 59'. Authorizations to import radioactive sources of ionizing radiation shall be issued provided that:
1. the person for whom said authorization is intended holds the necessary licence or permit authorizing the right to use and/or store such sources;
2. their carriage by a person licensed or authorized to perform carriage under this Act is ensured."
8. In Article 60:
(a) in Paragraph 2, the words "and/or national consultants for radiotherapy, nuclear medicine and roentgenology" are deleted;
(b) a new Paragraph 3 is inserted as follows:
"(3) The official coordination under Paragraph 2 shall be carried out with the obligation that the sources of ionizing radiation may be used for medical purposes";
9. Article 61 is repealed;
10. In Article 62, the words "or the holder of an authorization" are inserted after the words "the licensee".
§ 8. In Article 47, Paragraph 1 of the Higher Education Act (Promulgated SG No. 112/1995; Amended SG Nos. 28/1996, 56/1997; Emended SG No. 57/1997; Amended SG Nos. 58/1997, 60 and 113/1999, 54/2000, 22/2001, 40 and 53/2002, 48/2004) the words "the national centres for public health affairs" shall be inserted after the words "agrarian sciences".
§ 9. The Water Act (Promulgated SG No. 67/1999; Amended SG Nos. 81/2000, 34, 41 and 108/2001, 47, 74 and 91/2002, 42, 69, 84 and 107/2003, 6/2004) shall be amended as follows:
1. In Article 42, second sentence, the word "sanitary" is replaced by the words "for hygiene and epidemiology";
2. In Article 47, Paragraph 2, the words "public health establishments" are replaced by the words "medical establishments for hospital aid";
3. In Article 48, Paragraph 1, Item 7, the word "sanitary" is replaced by the words "for hygiene and epidemiology";
4. In Article 151, Item 1(f), the words "public health establishments" are replaced by the words "medical establishments for hospital aid";
§ 10. Everywhere in the Civil Registration Act (Promulgated SG No. 67/1999; Amended SG Nos. 28 and 37/2001, 54/2002, 63/2003), the words "healthcare establishment", "The healthcare establishment" and "specialised healthcare establishments" shall be replaced by the words "medical establishment", "the medical establishment" and "medical establishments" respectively.
§ 11. The Civil Aviation Act (Promulgated SG No. 94/1972; Amended SG Nos. 30/1990, 16/1997, 85/1998, 12/2000, 34 and 111/2001, 52/2004) shall be amended as follows:
1. In Article 71, Paragrah 1(a), the words "healthcare establishment" are replaced by the words "medical establishment";
2. In Article 85, Paragraph 2, the word "sanitary" is replaced by the word "healthcare".
§ 12. In Article 40, Paragraph 1 of the Value Added Tax Act (Promulgated SG No. 153/1998; Emended SG No. 1/1999; Amended SG Nos. 44, 62, 64, 103 and 111/1999, 63, 78 and 102/2000, 109/2001, 28, 45 and 117/2002, 37, 42, 86 and 109/2003, 53/2004), the words "healthcare establishments under the Public Health Act" shall be replaced by the words "national centres for public health affairs" and the words "medical specialists under the Public Health Act" shall be replaced by the words "medical specialists under the Health Act".
§ 13. In Article 123, Paragraph 1, Item 2(d) of the Road Traffic Act (Promulgated SG No. 20/1999; Amended SG Nos. 1/2000, 43, 45 and 76/2002, 16 and 22/2003, 6/2004), the words "healthcare establishment" are replaced by the words "medical establishment";
§ 14. In Article 83, Paragraph 4 of the Rail Transport Act (Promulgated SG No. 97/2000; Amended SG Nos. 47 and 96/2002), the word "sanitary" shall be replaced by the words "state health control authorities".
§ 15. In Article 32, Item 8 of the Child Protection Act (Promulgated SG No. 48/2000; Amended SG Nos. 75 and 120/2002, 36 and 63/2003), the words "of diseases under Arts. 36 and 36a of the Public Health Act" shall be replaced by the words "of AIDS and diseases under Article 61, Paragraph 1 and Article 146, Paragraph 1, Items 1 and 2 of the Health Act".
§ 16. In Article 37, Paragraph 2, Item 2 of the Replacement of Military Obligations by an Alternative Service Act (Promulgated SG No. 131/1998; Amended SG Nos. 69/1999, 49/2000, 50/2003), the words "state sanitary control authorities" shall be replaced by the words "state health control authorities".
§ 17. The Health Insurance Act (Promulgated SG No. 70/1998; Amended SG Nos. 93 and 153/1998, 62, 65, 67, 69, 110 and 113/1999, 1, 31 and 64/2000, 41/2001, 1, 54, 74, 107, 112, 119 and 120/2002, 8, 50, 107 and 114/2003, 28, 38 and 49/2004) shall be amended as follows:
1. In Article 49, the words "state sanitary control" are replaced by the words "state health control";
2. In Article 58, the words "and healthcare establishments under the Public Health Act" shall be replaced by the words "national centres for public health affairs under the Health Act".
§ 18. The Health and Safety at Work Act (Promulgated SG No. 124/1997; Amended SG Nos. 86/1999, 64 and 92/2000, 25 and 111/2001, 18 and 114/2003) shall be amended as follows:
1. In Article 25, a new Paragraph 6 is inserted as follows:
"(6) The activities of labour medicine services shall be subject to accreditation under the terms and conditions set out for accreditation of medical establishments under the Medical Treatment Facilities Act.";
2. In Article 37, Paragraph 6, the word "sanitary" is replaced by the word "healthcare".
§ 19. In Article 9 of the Implementation of Penal Sanctions Act (Promulgated SG No. 30/1969; Amended SG Nos. 34/1974, 84/1977, 36/1979, 28/1982, 27 and 89/1986, 26/1988, 21/1990, 109/1993, 50/1995, 12 and 13/1997, 73 and 153/1998, 49/2000, 62 and 120/2002, 61/2004), the words "sanitary requirements" shall be replaced by the words "healthcare requirements".
§ 20. The Blood, Blood Donation and Blood Transfusion Act (Promulgated SG No. 102/2003) shall be amended as follows:
1. A new Article 34a is inserted as follows:
"Article 34a. (1) All medical establishments for hospital aid and dispensaries with beds may take blood for autohaemotransfusion, while observing the requirements under Article 12, Paragraph 2, where there exist no medical counter indications thereof and upon receipt of an informed consent in writing.
(2) Where the person is under age, the informed consent in writing shall be obtained from the legitimate representative or guardian of the person under age."
2. A new § 13 is inserted in the Additional Provision as follows:
"13. "Autohaemotransfusion" is the method, whereby the patient is transfused blood taken from the patient in advance."
§ 21. Everywhere in the Human Medicinal Drugs and Pharmacies Act (Promulgated SG No. 36/1995; SG No. 61/1996 - Judgement No. 10/1996 of the Constitutional Court; Amended SG Nos. 38/1998, 30/1999, 10/2000; SG No. 37/2000 - Judgement No. 3/2000 of the Constitutional Court; Amended SG No. 59/2000; SG No. 78/2000 - Judgement No. 7/2000 of the Constitutional Court; Amended SG Nos. 41/2001, 107 and 120/2002; Emended SG No. 2/2003; Amended Nos. 56, 71 and 112/2003), the words "the Chief State Sanitary Inspector" shall be replaced by the words "the Chief State Health Inspector" and the words "inspectorates for hygiene and epidemiology" shall be replaced by the words "the regional inspectorate for public health protection and control" and "regional inspectorates for public health protection and control" respectively.
§ 22. The Medical Treatment Facilities Act (Promulgated SG No. 62/1999; Amended SG Nos. 88 and 113/1999; Amended SG No. 114/1999; Amended SG Nos. 36, 65 and 108/2000; SG No. 51/2001 - Judgement No. 11/2001 of the Constitutional Court; Amended SG Nos. 28 and 62/2002, 83, 102 and 114/2003) shall be amended as follows:
1. In Article 86:
(a) a new Paragraph 2 is inserted as follows:
"(2) Medical establishments other than those under Paragraph 1 shall be Subject to voluntary accreditation for assessment of their base capacity to train students, postgraduates and medical doctors for the purposes of the continuous medical education";
(b) the current Paragraph 2 becomes Paragraph 3;
2. Article 91 is amended as follows:
"Article 91. Medical establishments for outpatient care may offer practical training of postgraduates in the specialties laid down in the an ordinance under Article 181 of the Health Act and training for the purposes of the continuous medical education."
3. Article 115 is amended as follows:
(a) in Paragraph 1, the words "from BGN 100 to BGN 300" are replaced by the words "from BGN 1,000 to BGN 3,000";
(b) a new Paragraph 2 is inserted as follows:
"(2) Whoever provides outpatient medical care in violation of Article 39 shall be punished with a fine from BGN 2,000 to BGN 5,000 and, in the case of repeated violation, with withdrawal of the right to practice the profession from three months to one year";
(c) the current Paragraph 2 becomes Paragraph 3 and there the words "from BGN 200 to BGN 500" are replaced by the words "from BGN 2,000 to BGN 5,000";
4. In Article 116:
(a) in Paragraph 1, the words "from BGN 100 to BGN 500" are replaced by the words "from BGN 1,000 to BGN 5,000";
(b) in Paragraph 2, the words "from BGN 750 to BGN 2,000" are replaced by the words "from BGN 8,000 to BGN 20,000";
5. Everywhere in the Act, the words "district healthcare centre", "the district healthcare centre" and "district healthcare centres" are replaced by the words "regional healthcare centre", "the regional healthcare centre" and "regional healthcare centres" respectively, while the words "inspectorate for hygiene and epidemiology" shall be replaced by the words "the regional inspectorate for public health protection and control".
§ 23. In Article 6, Paragraph 1 of the Local Taxes and Fees Act (Promulgated SG No. 117/1997; Amended SG Nos. 71, 83, 105 and 153/1998, 103/1999, 34 and 102/2000, 109/2001, 28, 45, 56 and 119/2002, 84 and 112/2003, 6, 18 and 36/2004), the words "kitchens for children" shall be inserted after the word "crèches".
§ 24. In Article 82 of the Ministry of Interior Act (Promulgated SG No. 122/1997; SG No. 29/1998 - Judgement No. 3/1998 of the Constitutional Court; Amended SG Nos. 70, 73 and 153/1998, 30 and 110/1999, 1 and 29/2000, 28/2001, 45 and 119/2002, 17, 26, 95, 103, 112 and 114/2003, 15/2004) shall be amended as follows:
"(3) Sobering facilities shall be established by the Ministry of Interior in coordination with local governments."
§ 25. The Maritime Space, Inland Waterways and Ports of the Republic of Bulgaria Act (Promulgated SG No. 12/2000; Amended SG Nos. 111/2001, 24/2004) shall be amended as follows:
1. In Article 23, Paragraph 1, the word "sanitary" is replaced by the word "healthcare".
2. In Article 38 and Article 66, Item 2, the words "sanitary provisions" are replaced by the words "healthcare requirements".
§ 26. In Article 19, Paragraph 2, Item 1 of the Personal Income Tax Act (Promulgated SG No. 118/1997; SG No. 35/1998 - Judgement No. 6/1998 of the Constitutional Court; Amended SG Nos. 71 and 153/1998, 50, 103 and 111/1999, 105/2000, 110/2001, 40, 45, 61 and 118/2002, 42, 67, 95 and 112/2003, 36, 37 and 53/2004), the words "and health" shall be deleted.
§ 27. In Article 95 of the Waste Management Act (Promulgated SG No. 86/2003), the words "the director of the inspectorate for hygiene and epidemiology" is replaced by the words "the director of the regional inspectorate for public health care and control" and the word "sanitary" is replaced by the word "healthcare".
§ 28. In the Environmental Protection Act (Promulgated SG No. 91/2002; Emended SG No. 98/2002; Amended SG No. 86/2003), in Chapter Three after Article 59 a new Section VIII shall be inserted under the title Protection of the Environment Against Asbestos Pollution with Article 59a as follows:
"Section VIII. Protection of the Environment Against Asbestos Pollution
Article 59a. (1) The Minister of the Environment and Water, in consultation with the Minister of Health, shall issue an ordinance to establish:
1. the requirements and measures to prevent and reduce the asbestos pollution of air and water;
2. the methods and procedures for defining asbestos in dust emissions;
3. the methods and procedures for defining the concentration of undisclosed substances in asbestos-containing waste waters;
4. the cases, where exceptions to the requirements and measures under Item 1 may be allowed.
(2) The Minister of the Environment and Water may authorise the use of methods and procedures other than those under Paragraph 1 provided that they yield equivalent data and results."
§ 29. In Article 200k of the Judicial System Act (Promulgated SG No. 59/1994; SG No. 78/1994 - Judgement No. 8/1994 of the Constitutional Court; SG No. 87/1994 - Judgement No. 9/1994 of the Constitutional Court; SG No. 93/1995 - Judgement No. 17/1995 of the Constitutional Court; Amended SG Nos. 104 and 110/1996, 58, 122 and 124/1997, 11 and 133/1998; SG No. 6/1999 - Judgement No. 1/1999 of the Constitutional Court; Amended SG Nos. 34, 38 and 84/2000, 25/2001, 74/2002; SG No. 110/2002 - Judgement No. 11/2002 of the Constitutional Court; No. 118/2002 - Judgement No. 13/2002 of the Constitutional Court; Amended SG Nos. 61 and 112/2003, 29 and 36/2004), a new Paragraph 3 shall be inserted as follows:
"(3) The ordinance under Paragraph 2 shall establish also the terms and conditions for calculating and paying the costs of medical establishments in the preparation of forensic medical expert reports."
§ 30. The Doctors and Dentists Professional Organisations Act (Promulgated SG No. 83/1998) shall be amended as follows:
1. In Article 4, the words "Articles. 88 and 93 of the Public Health Act" are replaced by the words "Chapter Seven, Section II of the Health Act";
2. In Article 5, Item 4, the words "together with the National Health Insurance Fund" are deleted;
3. Article 9, Item 9 is repealed;
4. In Article 32, Paragraph 3:
(a) Item 2 is amended as follows:
"2. a certificate of legal competence under the Health Act;";
(b) Item 6 is amended as follows:
"6. for foreign nationals - a long-term stay and work permit and a certificate of legal competence under the Health Act.";
5. In Article 33, Paragraph 1, the words "Articles. 88 and 93 of the Public Health Act" are replaced by the words "Chapter Seven, Section II of the Health Act";
6. A new § 6a is inserted in the Transitional and Final Provisions:
"§ 6a. The Bulgarian Doctors' Union and the Union of Dentists in Bulgaria shall draft and adopt Rules for Good Medical Practice and submit them for approval to the Minister of Health before 31 July 2005."
§ 31. In Article 4. Paragraph 4 of the Gambling Act (Promulgated SG No. 51/1999; Amended SG Nos. 103/1999, 53/2000, 1, 102 and 110/2001, 75/2002, 31/2003), a comma and the word "healthcare" shall be inserted after the word "educational".
§ 32. Everywhere in the Foodstuffs Act (Promulgated SG No. 90/1999; Amended SG No. 102/2003), the words "state sanitary control" shall be replaced by the words "state health control", the words "the Public Health Act" shall be replaced by the words "the Health Act" and the words "the Chief State Sanitary Inspector" shall be replaced by the words "the Chief State Health Inspector".
§ 33. In Article 24, Paragraph 1, Item 4 of the Foreigners in the Republic of Bulgaria Act (Promulgated SG No. 153/1998; Amended SG Nos. 70/1999, 42 and 112/2001, 45 and 54/2002, 37 and 103/2003, 37/2004), the words "healthcare establishment" are replaced by the words "medical establishment";
§ 34. Article 30, Paragraph 2 of the Tobacco and Tobacco Products Act (Promulgated SG No. 101/1993; Amended SG Nos. 19/1994, 110/1996, 153/1998, 113/1999, 33 and 102/2000, 110/2001, 20/2003, 57/2004) shall be amended as follows:
1. Item 1 is amended as follows:
"1. within the territory of crèches and kindergartens, schools, school boarding houses, medical and healthcare establishments;";
2. Item 5 is amended as follows:
"5. which do not meet healthcare requirements;";
3. In Item 11, the words "at outlets licensed for duty-free trade" are deleted;
4. A new Item 16 is inserted as follows:
"16. at sports and public events organised for children and pupils."
§ 35. In the Social Insurance Code (Promulgated SG No. 110/1999; SG No. 55/2000 - Judgement No. 5/2000 of the Constitutional Court; Amended SG Nos. 64/2000, 1, 35 and 41/2001, 1, 10, 45, 74, 112, 119 and 120/2002, 8, 42, 67, 95, 112 and 114/2003, 12, 38, 52 and 53/2004), Articles 14, 15, 16 and 17 shall be repealed.
§ 36. The Protection against Discrimination Act (Promulgated SG No. 86/2003) shall be amended as follows:
1. In Article 4, Paragraph 1, the words "human genome" are inserted after the words "ethnic origin";
2. A new Item 14 is inserted in § 1 of the Additional Provision:
"14. "Human genome" is the sum total of all genes in a single (diploid) set of chromosomes of an individual."
§ 37. The Personal Data Protection Act (Promulgated SG No. 1/2002) shall be amended as follows:
1. In Article 2, Paragraph 1, the words "as well as the human genome data" shall be inserted at the end;
2. A new Item 10 is inserted in § 1 of the Additional Provision:
"10. "Human genome" is the sum total of all genes in a single (diploid) set of chromosomes of an individual."
§ 38. The Council of Ministers shall adopt and the Minister of Health shall issue the secondary legislation on the implementation of this Act within a year of its effective date.
§ 39. Pending the entry into force of the secondary legislation under § 38, the existing secondary legislation on the implementation of the repealed Public Health Act shall apply, insofar as they do not contravene this Act.
§ 40. The implementation of this Act is hereby assigned to the Minister of Health.
§ 41. This Act shall enter into force on 1 January 2005, except for Article 53, Paragraph 3 which shall enter into force on 1 January 2006.


TRANSITIONAL AND FINAL RPOVISIONS
to the Act to Amend and Supplement
of the Health Act
(SG, No. 85/2005, effective 25.10.2005, amended, SG No. 59/2007)
§ 17. (1) The higher schools shall provide the training and the acquisition of "bachelor" educational and qualification degree in specialties from the "Health Care" vocational sector under the procedure of the Higher Education Act by the beginning of the 2006/2007 academic year.
(2) The persons who have begun their training in the specialties of "medical nurse" and "midwife" from the "Health Care" vocational sector of the "specialist" educational and qualification degree and by September 1, 2006 have not completed their education, shall continue their education at a department or branch of a higher school in the next academic year in the respective specialty from the "Health Care" vocational sector for the acquisition of a "bachelor" education and qualification degree without previously sitting for admission exams.
(3) (Repealed, SG no. 59/2007).
(4) The persons who have begun their "specialist" educational and qualification training as "remedial gymnast", "medical lab expert", "x-ray lab expert", "sanitary inspector" and "masseur" of the "Public Health" vocational section, as "dental mechanic" of the "Dentistry" vocational section and as "assistant pharmacist" of the "Pharmacology" vocational section, shall continue their training in the same specialties for acquiring the same educational degree in the "Health Care" vocational section.

TRANSITIONAL AND FINAL PROVISIONS
of the Administrative Procedure Code
(SG, No. 30/2006, effective 12.07.2006)
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
§ 61. In the Health Act (Promulgated, SG No. 70/2004, supplemented, SG No. 46/2005, amended and supplemented, SG No. 76/2005, SG No. 85/2005, amended, No. 88/2005, amended and supplemented, SG No. 94/2005, amended, SG No. 103/2005, amended and supplemented, SG No. 18/2006) shall be amended as follows:
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2. Everywhere in the Act the words "the Administrative Procedure Act" and "the Supreme Administrative Court Act" shall be replaced by "the Administrative Procedure Code".
FINAL PROVISIONS
to the Act to Amend and Supplement the Health Act
(SG No. 59/2006, effective 1.01.2007)
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
§ 21. This Act shall become effective on January 1, 2007, with the exception of § 4, 5 and 14 which shall become effective on the day of their promulgation in the State Gazette.
(*) Act to Amend the Commercial Register Act
(SG No. 80/2006, effective 3.10.2006)
§ 1. In § 56 of the Transitional and Final Provisions the words "1 October 2006" shall be replaced by "1 July 2007"
........................................................................
TRANSITIONAL AND FINAL PROVISIONS
to the Act to Amend and Supplement the Health Act
(SG No. 81/2006)
§ 5. (1) Handicraft enterprises providing services in the field of optics and optometry in operation by the date this Act becomes effective may continue to operate if they register under the procedure of Article 26b herein with the respective RHC within six months.
(2) Within six months after this Act becomes effective the owners of handicraft enterprises or the heirs, or the legal successors, providing services in the field of optics and optometry, as well as the apprentices, journeymen and masters, shall submit an application to the respective crafts chamber for the expungement thereof from the respective registers referred to in Articles 21, 48, 54 and 63 of the Skilled Crafts Act.
(3) In the cases referred to in Paragraph (2) the regional crafts chambers shall expunge the registration of the respective persons within 14 days following the filing of the application and shall issue a certificate for expungement of journeymen and masters on the basis of which they may enjoy the rights referred to in Article 26a.
§ 6. (1) The persons with acquired professional qualification in Optometry shall enjoy the rights referred to in Article 26a (2) and (3) and may undertake measures for the correction of sight.
(2) Persons with acquired professional qualification as "assistant pharmacist and dispensing optician" shall enjoy the rights referred to in Article 26a (2) and (3), and the persons with acquired professional qualification in Optics, Optomechanical and Optoelectronic Devices shall enjoy the rights referred to in Article 26a (3).
Medicinal Products in Human Medicine Act
TRANSITIONAL AND FINAL PROVISIONS
(Promulgated, SG No. 31/13.04.2007)
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§ 19. (1) Within a period of three months of the entry of this Act into force:
1. The Council of Ministers shall amend and supplement the Organic Rules of the Bulgarian Drugs Agency, bringing it in line with this Act;
2. The Minister of Health shall issue the Ordinance under Art. 82, para 3.
(2) Within a period of up to 6 months of the entry of this Act into force, the Council of Ministers shall adopt and the Minister of Health shall issue the other legislative instruments for the implementation of this Act.
§ 20. After expiry of the first two years of the term of office of the members of Commissions under Art. 103, 107, 259 and 261, half of the members whose term of office will terminate shall be drawn by lot.
§ 21. Within a period of up to one year of the entry of this Act into force, the Bulgarian Drugs Agency shall take the necessary action to have its laboratory for the control of medicinal products and active substances accredited by the European Directorate for the Quality of Medicines and Healthcare.
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§ 36. Until entry into force of the instruments under § 19, legal instruments issued for the implementation of the repealed Human Medicinal Drugs and Pharmacies Act shall apply, insofar as they do not stand in contradiction hereto.
§ 37. This Act shall become effective on the day of its publication in the State Gazette with the exception of § 22, which shall enter into force one year after the entry of this Act into force.


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