ORDER OF THE MINISTRY OF HEALTH OF THE REPUBLIC OF MOLDOVA

of November 18, 2004 No. 344

About regulation of registration/re-registration of medicines and modification of registration documents during action of the registration certificate

In pursuance of provisions of the laws on pharmaceutical activities of N1456-XII of 25.05.1993, medicines of medical appointment N1409-XIII of 17.12.1997 and the Order of the Government of the Republic of Moldova N1135 of 18.09.2003, and also for the purpose of ensuring efficiency, safety and quality of medicines and coordination of process of forming of range of the medicines allowed to application in medical practice I APPROVE:

1. Regulations on registration of medicines (Appendix 1).

2. Standard rates concerning materials on medicines which move on the state registration / re-registration (Appendix 2).

3. Regulations on the post-registration changes requiring new registration of medicine (Appendix 3).

4. Regulations on conducting examination of post-registration changes, type I, to the registration certificate (Appendix 4).

5. Regulations on conducting examination of post-registration changes, type II, to the registration certificate (Appendix 5).

6. The standard form of the registration certificate of medicine (appendix 6) I ORDER:

1. Appoint National institute of pharmacy responsible for examination, specialized assessment and registration of medicines, other pharmaceutical products and products of medical appointment.

2. To the director of National institute of pharmacy (Mr. Boris Pary):

2.1. Organize process of activities of the divisions responsible for examination, specialized assessment and registration of medicines, other pharmaceutical products according to

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