Pharmaceutical activity includes wholesale and retail trade in pharmaceuticals, as well as their manufacture. To carry out these types of activities, you must obtain a special license.
Instructions
Step 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 constituent agreement, the order on the appointment of the director of the organization, the certificate of assignment of the TIN, extract from the Unified State Register of Legal Entities, diplomas of pharmaceutical education and certificates of specialists, codes of the State Statistics Committee. Provide a copy of the lease agreement for the premises or a certificate of ownership to the notary for certification.
Step 2
Get a sanitary and epidemiological conclusion on the compliance of the work performed and the services provided with the relevant rules.
Step 3
Obtain an opinion from the bodies of the State Fire Service on compliance with safety standards.
Step 4
List the professionals who will work for the organization. Place the seal of the organization and the signature of the manager on it.
Step 5
Prepare a description of the licensed object. Indicate the number of rooms, footage, methods of operation in the organization of pharmaceutical activities.
Step 6
Pay the license fee. At the end of September 2011, the fee is 2,600 rubles. Attach the original payment order to the general package of documents.
Step 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 Healthcare and Social Development of the constituent entity of the Russian Federation where you intend to carry out pharmaceutical activities. The license for retail trade in medicinal products is regional, for wholesale trade - federal.
Step 8
The term for consideration of documents and making a decision on the issue of issuing 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.