How to get a pharmaceutical license

Pharmaceutical activities include the wholesale and retail sale of medicines, as well as their manufacture. To carry out these types of activities, you must obtain a special license.

Instruction manual

1

Contact a notary public. Receive from him certified copies of the certificate of registration of a legal entity or individual entrepreneur, the charter of the organization, the memorandum of association, the order on the appointment of the director of the organization, certificate of TIN assignment, extract from the register, pharmaceutical education diplomas and specialists certificates, Goskomstat codes. Provide a notary with a copy of the rental agreement or a certificate of ownership for certification.

2

Get a sanitary and epidemiological opinion on the compliance of the work and services provided with the relevant rules.

3

Obtain an opinion from the State Fire Service on compliance with safety standards.

4

Make a list of specialists who will work in the organization. Put on it the seal of the organization and the signature of the head.

5

Prepare a description of the licensed item. Indicate the number of rooms, footage, methods of operation when organizing pharmaceutical activities.

6

Pay the license fee. As of the end of September 2011, the amount of the fee is 2, 600 rubles. Attach the original of the payment order to the general package of documents.

7

Write an application for a pharmaceutical license. Submit it with a full package of documents to the Office of the Federal Service for Supervision of Health and Social Development of the subject of the Russian Federation where they intend to carry out pharmaceutical activities. The license for the retail sale of medicines is regional, and the wholesale trade is federal.

8

The term for consideration of documents and decision-making on the issue of a license is up to 45 days from the date of submission of a full package of documents. The license is issued for 5 years.