ORDER OF THE GOVERNMENT OF THE REPUBLIC OF ARMENIA

of March 7, 2019 No. 156-N

About establishment of procedure for professional observation for the purpose of certification of the supplier and issue of the certificate on activities for proper distribution, procedure for examination and the list of necessary documents for the purpose of licensing of wholesale of drugs

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

Assuming as a basis part 6 of article 24 of the Law of the Republic of Armenia "About drugs", the Government of the Republic of Armenia decides:

1. Establish:

1) procedure for professional observation for the purpose of certification of the supplier and issue of the certificate on activities for proper distribution according to Appendix No. 1;

2) procedure for examination for the purpose of licensing of wholesale of drugs according to Appendix No. 2;

3) the list of the documents necessary for examination for the purpose of licensing of wholesale of drugs according to Appendix No. 3.

2. 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. 156

Procedure for professional observation for the purpose of certification of the supplier and issue of the certificate on activities for proper distribution

1. General provisions

1. This Procedure governs the relations connected with professional observation of compliance to rules of activities for proper distribution of drugs (further – observation of the DPR) and issue of the certificate on activities for proper distribution.

2. The concepts established by rules of activities for proper distribution (further – the DPR), approved by the Ministry of Health of the Republic of Armenia (further – the Ministry) according to part 1 of article 24 of the Law of the Republic of Armenia "About drugs", are applicable in the same sense and in this Procedure.

3. The observations of the DPR established by part 7 of article 24 of the Law of the Republic of Armenia "About drugs" are performed by the expert organization established by the Government of the Republic of Armenia (further – the Organization).

4. The expenses connected with the DPR according to part 6 of article 24 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. The payment does not return, irrespective of results of observation.

5. The current observations in the territories of the legal entities and individual entrepreneurs having the license for wholesale of drugs within the first 3 years after receipt of the license for wholesale of drugs, it is performed annually, then – time in each two years, being guided when planning by instructions of the international organization "The scheme of cooperation of the pharmaceutical companies" about risk analysis.

6. Observations of the DPR are performed according to the procedures approved in the quality management system installed by articles of organization.

2. Process of observation of the DPR

7. For the purpose of implementation of observations of the DPR the supplier submits the application to the Organization. Observation of the DPR begins in the presence of the document confirming the fact of payment of expenses on observation.

8. For the purpose of the organization of observation of the DPR the Organization at least within 10 working days performs observation preparation, develops the plan of implementation of observation, including framework of observation of the DPR which at least in 2 days prior to observation represents to the supplier.

9. Observation is performed in three main stages within no more than three working days.

10. At the first stage of observation there is preliminary meeting with the head and key personnel (the responsible person, division managers) during which:

1) specialist of the DPR:

and. describes the purpose and framework of observation;

. studies and discusses organizational structure of the supplier;

notes century organizational actions for effective implementation of observation which will be approved with the supplier;

2) head of executive body of the legal entity or individual entrepreneur:

and. represents quality management system, and also corrections of the variations and shortcomings registered during the previous observation after the previous observation;

. appoints the attendant for the expert of the DPR to whom all components of quality assurance of the supplier are known;

provides the room for the expert (experts) of the DPR century (if necessary).

11. At the second stage of observation it is carried out detailed observations. For this purpose:

1) the expert(s) of the DPR performs bypass, watching the organization of process of the wholesale supply. During bypass detailed studying of compliance of engineering solutions of arrangement of the room of deliveries, internal finishing, airsupply of rooms, documentation of actions, knowledge and skills of personnel and other components of the DPR are performed. After bypass detailed studying of the documents connected with delivery processes, working descriptions, protocols of validation, claims and responses, the system of self-inspection installed by rules of the DPR, and other documents connected with the DPR are performed;

2) all variations it is declared and in brief discussed during bypass and studying in the presence of responsible persons, and only after that they are registered as shortcomings;

3) in the course of observation sampling can be performed. Parallel to the sampling performed by the expert, the supplier can also perform similar sampling for the purpose of the organization of own research within the matter of argument.

12. At the third stage of observation there is closing meeting at which surely there are key personnel, all revealed shortcomings, variations, omissions are discussed and preliminary terms of their correction will be coordinated.

13. For the purpose of ensuring efficiency of observation of the DPR the expert of the DPR prior to observation can make preliminary bypass for acquaintance with arrangement and structure of the room.

14. For the purpose of ensuring efficiency the expert of the DPR in the course of observation can make observations of the DPR photo and video filming.

15. Shortcomings and variations from rules of the DPR and the processes established by them are subdivided on levels into 3 groups:

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