In Russia begins to act, mandatory labeling of medicines

Mandatory labeling of the drugs begins to act in response to the environment – all manufacturers of drugs shall be marked and the persons engaged in the production, storage, import in the Russian Federation, vacation, sale, transfer, use and destruction of drugs, will be required to provide information about drugs in a system of monitoring their movement.

Relevant Federal law was signed by President of Russia at the end of December 2019.

Mandatory labeling of all medications was to begin in Russia on January 1, 2020. However, monitoring of readiness for mandatory labeling showed that most pharmacy organizations to transition to the new system since January, not ready, in this regard, the date of entry into force of compulsory labelling of medicines were transferred.

Thus from October 1, 2019, pharmaceutical companies have put code labeling of drugs for the treatment of rare diseases, and participants in the trafficking of such drugs introduced into the system data on drugs at all stages of their movement. As noted by the Deputy head of Department of organization of state quality control of medical products of Roszdravnadzor Elena Kudryavtseva, the markings still on the stage of the experiment it was revealed offences (re-stuffing and re-sale of drugs bought on the gostorg) in the amount of 500 million rubles.

In mid-June, the press service of the healthcare Ministry reported that working with labeled drugs already prepared most of the pharmacies in the regions of the country.

In late June, the health Ministry said that all Russian manufacturers of drugs, which has no analogues registered in the marking system.

In addition, on June 23, the state Duma at plenary session passed in the second reading of the bill, which establishes the right of the government to defer the introduction of mandatory labelling for a number of drugs for three to six months.

In a press-service of the Ministry of health stated that granting the government of the Russian Federation such powers will neutralize minor difficulty and all patients receive the necessary medication.

In a press-service Roszdravnadzora noted that the labeling of drugs will provide Russians with high quality effective and safe medications, and also protect the market from counterfeit medicines and allows to simultaneously withdraw from circulation products that do not meet the requirements.

Labeling will also allow the Russians to independently verify the legality of the purchased medications via a mobile app on your smartphone and send complaints in case of violations, said the health Ministry.