ORDER OF THE GOVERNMENT OF THE REPUBLIC OF ARMENIA

of March 14, 2019 No. 199-N

About establishment of procedures for observation of compliance of production of drugs and medicinal substances to rules of proper production practice, issue of the certificate on proper production practice, and also examination procedure for the purpose of licensing of production of drugs and the list of necessary documents and recognition of the Orders of the Government of the Republic of Armenia of November 25, 2010 No. 1603-N and the Governments of the Republic of Armenia of September 23, 2013 No. 1089-N invalid

Accepted the Government of the Republic of Armenia on February 28, 2019

Assuming as a basis part 10 of article 18 of the Law of the Republic of Armenia "About drugs", the Government of the Republic of Armenia decides:

1. Establish:

1) procedure for observation of compliance of production of drugs and medicinal substances to rules of proper production practice according to Appendix No. 1;

2) procedure for issue of the certificate on proper production practice according to Appendix No. 2;

3) examination procedure for the purpose of licensing of production of drugs according to Appendix No. 3;

4) the list of the documents necessary for observation of compliance to rules of proper productive activity and implementation of examination for the purpose of licensing of production of drugs according to Appendix No. 4.

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