Document from CIS Legislation database © 2003-2021 SojuzPravoInform LLC

ORDER OF THE GOVERNMENT OF THE RUSSIAN FEDERATION

of July 6, 2012 No. 686

About approval of the Regulations on licensing of production of medicines

(as amended on 02-12-2020)

According to the Federal Law "About Licensing of Separate Types of Activity" Government of the Russian Federation decides:

1. Approve the enclosed Regulations on licensing of production of medicines.

Russian Prime Minister

D. Medvedev

Approved by the Order of the Government of the Russian Federation of July 6, 2012 No. 686

Regulations on licensing of production of medicines

1. This Provision establishes procedure for licensing of the activities for production of medicines performed by legal entities according to the Federal Law "About Drug Circulation".

2. Licensing of activities for production of medicines for medical application performs the Ministry of Industry and Trade of the Russian Federation, for veterinary application - Federal Service for Veterinary and Phytosanitary Surveillance (further - licensing authorities).

3. Activities for production of medicines include works on the list according to appendix.

4. The licensed requirements imposed to the license applicant on implementation of activities for production of medicines (further - the license), are:

a) availability at the license applicant of the rooms, buildings, constructions and other objects, technical means, the equipment and technical documentation belonging to it on the property right or on other legal cause necessary for accomplishment of the declared works conforming to the established requirements;

b) compliance of production of medicines for veterinary application to rules of proper production practice according to article 45 of the Federal law "About Drug Circulation";

(1)) compliance of production of medicines for medical application to rules of proper production practice of the Eurasian Economic Union;

c) availability according to article 45 of the Federal law "About Drug Circulation" of the industrial regulations approved by the head of the producer of medicines (license applicant) and including the list of the used pharmaceutical substances and excipients with indication of quantity of each of them, this about the used equipment and the description of engineering procedure and control methods at all production phases of medicines;

d) availability according to article 45 of the Federal law "About Drug Circulation" of the authorized person of the producer of medicines for veterinary application which in case of input of medicines for veterinary application in civil circulation performs confirmation of conformity of medicines for veterinary application to the requirements established in case of their state registration and guarantees that medicines are made for veterinary application according to rules of proper production practice, has education and the length of service conforming to requirements, the stipulated in Clause 45 Federal Laws "About Drug Circulation" in case of production of medicines for veterinary application and is certified according to the procedure, established by the Ministry of Agriculture of the Russian Federation;

(1)) availability of the authorized person (authorized persons) of the producer of medicines for medical application, being his worker which in case of input of medicines in civil circulation performs confirmation of conformity of medicines to the requirements established in case of their state registration and guarantees that medicines are made according to requirements of Rules of proper production practice of the Eurasian Economic Union which is certified and included in the register of authorized persons of producers of medicines of the Eurasian Economic Union according to the right of the Eurasian Economic Union;

e) availability of the workers who signed employment contracts, having respectively the higher or secondary professional pharmaceutical, chemical, chemical and technology, biological, biotechnology, medical or veterinary education responsible for production, marking and quality control of medicines.

4(1). In case of intention of the license applicant to perform production of pharmaceutical substance of alcohol of ethyl (ethanol) along with the licensed requirements specified in item 4 of this provision the following licensed requirements are imposed:

Warning!!!

This is not a full text of document! Document shown in Demo mode!

If you have active License, please Login, or get License for Full Access.

With Full access you can get: full text of document, original text of document in Russian, attachments (if exist) and see History and Statistics of your work.

Get License for Full Access Now

Disclaimer! This text was translated by AI translator and is not a valid juridical document. No warranty. No claim. More info

Effectively work with search system

Database include more 50000 documents. You can find needed documents using search system. For effective work you can mix any on documents parameters: country, documents type, date range, teams or tags.
More about search system

Get help

If you cannot find the required document, or you do not know where to begin, go to Help section.

In this section, we’ve tried to describe in detail the features and capabilities of the system, as well as the most effective techniques for working with the database.

You also may open the section Frequently asked questions. This section provides answers to questions set by users.

Search engine created by SojuzPravoInform LLC. UI/UX design by Intelliants.