Due to the establishment of common drug market of EAEU, the Russian government is preparing the amendments to the legislation regarding the release of drugs into civil circulation. The proposed changes may complicate the operation of Russian distributors.
Until now, the drugs need to pass a certification in Russia but, according to EAEU documents, this should be a different procedure. The Ministry of Health elaborated the corresponding amendments to the Federal Law No. 61. For Russian pharmaceutical manufacturers, it will be sufficient to obtain the confirmation of the qualified person. For foreign companies, the procedure will be different. The conformity of the imported drug to the requirements established at its registration must be confirmed by the organization, which is importing the medicinal product to Russia and has been authorized by the foreign manufacturer.
In other words, if the drug is imported by a distributor which, in most cases, possesses a license only for pharmaceutical activities, it will have to perform the functions of manufacturers.
“A distributor importing the medicinal product into the Russian Federation has no legal grounds and competencies to assess the compliance of the foreign manufacturer with the good manufacturing practices, as well as the conformity of imported medicinal product to the requirements set at its state registration, that could be performed exclusively by the qualified person of the manufacturer, according to the law,” stated the letter submitted to Olga Golodets.
The introduction of this rule will require the importing companies to restructure their business procedures in a way that is not yet defined.