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.

2. Recognize invalid the Orders of the Government of the Republic of Armenia of November 25, 2010 as No. 1603-N "About approval of rules of proper practice on production of drugs" and the Governments of the Republic of Armenia of September 26, 2013 No. 1089-N "About approval of procedures for observation of compliance of production of drugs and medicinal substances in the Republic of Armenia to rules of proper production practice and issue of the certificate on proper production practice".

3. This Resolution becomes effective for the tenth day after its official publication.

Appendix № 1

to the Order of the Government of the Republic of Armenia of February 28, 2019 No. 199-N

Procedure for observation of compliance of production of drugs and medicinal substances to rules of proper production practice

1. General provisions

1. This Procedure governs the relations connected with observation of compliance of production of drugs and medicinal substances to rules of proper production practice (further - observation of Scientific Production Enterprise). Observation of NPP Eurasian Economic Union (further - EEU) according to the statement of the applicant is performed according to Rules of pharmaceutical observation of EEU and procedure for ensuring joint pharmaceutical observation.

2. The concepts established by the rules of proper production practice (further - Scientific Production Enterprise) approved by the Ministry of Health of the Republic of Armenia (further - the ministry) according to the Law of the Republic of Armenia "About drugs", in the same sense are applicable also in this Procedure.

3. According to part 4 of article 18 of the Law of the Republic of Armenia "About drugs", observation of Scientific Production Enterprise is process of assessment of conformity to rules of Scientific Production Enterprise in the territory of production of drugs (including outsourcing) which covers also assessment of activities of laboratory for quality control, including works on the laboratory control exercised in contractual procedure.

4. Observation of Scientific Production Enterprise, established by part 5 of article 18 of the Law of the Republic of Armenia "About drugs", the expert organization established by the decision of the Government of the Republic of Armenia performs (further - the organization).

5. The expenses connected with observation of Scientific Production Enterprise (including travelers), according to part 4 of article 18 of the Law of the Republic of Armenia "About drugs", are compensated by the applicant based on the agreement signed between the parties according to the procedure, established by the Law.

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