BULGARIA
How does the ethical review process work in Bulgaria and which are the designated ethics committees?
Medical Devices Act
Section II
Authorisation for conducting clinical trials
Article 45.
(1) Clinical trials of medical devices under Article 2, Paragraph 1, item 3, of Class III, of implantable medical devices, and of invasive medical devices for long-term use under Article 2, Paragraph 1, item 3, of Class IIa or IIb, and of the devices under Article 2, Paragraph 1, item 2, which are conducted on the territory of the Republic of Bulgaria, may commence after receipt of positive opinion of the Ethics Committee for Multi-Centre Trials or of the ethics committee to the relevant medical care establishment, created under the Medicinal Products in Human Medicine Act, and after receipt of authorisation by the BDA Executive Director.
(2) Clinical investigations of medical devices other than those in Paragraph 1, which are conducted on the territory of the Republic of Bulgaria, may commence after notification of the BDA Executive Director, if the relevant ethics committee under Paragraph 1 has given a positive opinion.
(3) The provisions of Paragraphs 1 and 2 shall also apply to medical devices with affixed “CE” marking, where the clinical trials are conducted with the purpose of changing their intended purpose.
Article 46.
The sponsor, or the principal or coordinating investigator, may file an application for notification or for authorisation of the conducting of a clinical trial with the relevant ethics committee and with BDA simultaneously or consecutively.
Article 47.
(1) For a multi-centre clinical trial on the territory of the Republic of Bulgaria, the persons under Article 46 shall file an application with the Ethics Committee for Multi-Centre Trials.
(2) For a single-centre clinical trial on the territory of the Republic of Bulgaria, the persons under Article 46 may file an application with the Ethics Committee for Multi-Centre Trials or with the ethics committee created in the relevant therapeutic establishment.
Article 48.
(1) To obtain an opinion of the relevant ethics committee, the principal, respectively, the coordinating investigator or the sponsor, shall submit:
1. administrative documentation;
2. information on the participant;
3. documentation on the investigation plan;
4. documentation on the medical device under investigation;
5. documentation on the technical capacity of the therapeutic establishment and the professional qualification of the investigation team;
6. source of financing and administrative organisation of the trial.
(2) The content of the documentation under Article 1 shall be defined in an ordinance of the Minister of Health.
(3) Where the ethics committee finds that the documentation under Paragraph 1 is incomplete, it shall notify the applicant within 14 days and shall give him a deadline for eliminating the incompleteness.
(4) The ethics committee shall draft an opinion within 30 days of the submission of valid documentation, which shall be given to the applicant and to BDA.
Article 49.
(1) Where the opinion of the ethics committee under Article 48 is negative, the applicant within 14 days of the date of notification may appeal the decision with the Central Ethics Committee created under the Medicinal Products in Human Medicine Act.
(2) The Central Ethics Committee shall pronounce its decision within 14 days of the date of receipt of the sponsor’s written request.
(3) The decision of the Central Ethics Committee shall be final and mandatory for the ethics committee.