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ORDER OF THE GOVERNMENT OF THE REPUBLIC OF MOLDOVA

of January 18, 2016 No. 5

About National committee of ethical examination of clinical trials

Based on article 14 of the Law No. 263-XVI of October 27, 2005 on the rights and responsibility of the patient (The official monitor of the Republic of Moldova, 2005, Art. No. 176-181, 867) with subsequent changes and amendments, article 11 of the Law on drugs No. 1409-XIII for December 17, 1997 (The official monitor of the Republic of Moldova, 1998, Art. No. 52-53, 368), with subsequent changes and amendments, DECIDES: the Government

1. Found National committee of ethical examination of clinical trials as non-commercial public organization with financial autonomy in which the Ministry of Health is founder.

2. Approve:

Regulations on the organization and functioning of National committee of ethical examination of clinical trials according to appendix No. 1;

Rates for examination of documentation and issue of the conclusion for accomplishment of the clinical trials made by National committee of ethical examination of clinical trials according to appendix No. 2;

Changes and additions which are made to some orders of the Government according to appendix No. 3.

3. Establish the number of Committee in number of 15 people. For the purpose of the organization of activities to establish the personnel of committee administration in number of 3 units consisting from: the accountant, the assistant and one inspector on the personnel/legal adviser.

4. To committee to levy payment for examination of documentation and issue of the conclusion on performing clinical trials according to the regulations approved by this resolution.

5. Financing of the device and members of the committee will be performed at the expense of the money received from activities on the basis of self-government.

6. The means received for provision of services on examination of documentation and issue of the conclusion on performing clinical trials will accumulate on the special account of Committee and to be used for covering of current expenses according to the current legislation.

7. To the Ministry of Health within six months from coming into force of this resolution:

provide necessary conditions for implementation of proper activities by members of the committee;

bring the documentation into accord with this resolution.

Acting as Prime Minister

George Brega

Countersign:

Minister of Health

 

Ruksanda Glavan

Minister of Finance

Anatol Arapu

Minister of Labour, Social Protection and Family

Mircha of Bug

 

Appendix No. 1

to the Order of the Government of the Republic of Moldova of January 18, 2016 No. 5

Regulations on the organization and functioning of National committee of ethical examination of clinical trials

The regulations on the organization and functioning of National committee of ethical examination of clinical trials shift partially provisions of the Directive 2001/20/CE of the European Parliament and Council of April 4, 2001 about approximation of laws, rules and administrative resolutions of the member countries concerning realization of the high-quality clinical practice when performing clinical trials of medicines for application for people published in the Official magazine (JO) No. L 121 of May 1, 2001.

Chapter I. General provisions

1. The regulations on the organization and functioning of National committee of ethical examination of clinical trials (further – the Provision) regulate mission, functions, the rights and obligations of National committee of ethical examination of clinical trials (further – Committee).

2. The committee is the non-commercial public organization with financial autonomy which is acting on the basis of the principles of self-government and in which the Ministry of Health is the founder performing examination of documentation and issue of the conclusion on the clinical trials from the ethical point of view conducted in all territory of the Republic of Moldova with participation of patients or healthy people, providing protection of the rights, safety and wellbeing of subjects of clinical testing, and also observance of Rules of proper clinical practice (ICH-GCP).

3. The committee is legal entity, has seal and the treasurer account.

4. The committee performs the activities according to the provisions of the Constitution of the Republic of Moldova, the orders of the Government, other regulations, acts and protocols of the Ministry of Health, international standards recommended by the World Health Organization, conventions of the Council of Europe and also based on this provision. Members of the committee bear disciplinary, administrative or criminal responsibility for violation of requirements of this provision, as necessary.

5. In sense of this provision the following determinations are used:

regulating authorities – the bodies having the right to publish provisions, to check the provided clinical data and to perform inspections;

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