Latest news on labeling drugs

Since February 1, the amendments to the Federal Law No. 61 “On the circulation of medicinal products” came into effect, according to which, from January 1, 2020 (that is, less than a year later), the production and commissioning of medicinal products in the Russian Federation without a special two-dimensional over coding that allows you to trace the path of the medicine packaging from the manufacturer to the pharmacy counter, will be impossible.

In addition, all manufacturers of drugs, domestic and foreign, if they supply drugs to the Russian market, must connect to an automated system for tracking drugs.

To do this, you must send a letter in the approved form to the director of the Federal Budgetary Institution “State institute of medicines and good practices”.

If no connections by the year 2020 are planned, it is also necessary to send a corresponding information letter to the Deputy Minister of Industry and Trade of the Russian Federation, S. Tsyb, signed by the head of the company and (or) the holder of the registration certificate, with his translation into Russian, certified in the established order, at the address: Kitaygorodsky prospect., 7, Moscow, 109074.

At the same time, a scanned copy of the letter should be sent by e-mail: markirovka@gilsinp.ru; denisova@minprom.gov.ru.

Note:

Manufacturers of API and radiopharmaceuticals do not provide data.

On regulation.gov.ru,  Government Decree “On approving the amount of payment for rendering services on the provision of marking codes needed to generate identification means and ensure monitoring of the movement of goods coming under mandatory identification marks and the charging procedure”have been put for public debate..

As it is known, from the beginning of the next year, manufacturers must put a QR code on each package of drugs in order to make it easier for supervisory authorities and consumers to monitor the package of the drug and thereby “pull the plug” with counterfeit drugs.

Codes will be provided by the operator of the state monitoring information system. For providing the code, the operator will charge a fee of 50 kopecks excluding VAT.

The exception will be drugs from the list of vital drugs, the maximum selling price of the manufacturer does not exceed 20 rubles.

Forms of letters in Russian and English can be obtained by sending us a corresponding request to the mail regmed@regmed.biz