Pharma and medical devices

Ukraine: Amended drug registration procedure

As of 24 November 2017, manufacturers and importers of pharmaceuticals (drugs) are required to comply with the revised drug registration requirements.

The amendments to the drug (pharmaceutical/medicine) registration procedure have been introduced by Order No. 1202 of 2 October 2017.

Russia: Medical device technical documentation. Compulsory information to be provided by the manufacturer

Manufacturers and importers of medical devices that submit a registration application for these devices after 24 March 2017, have to ensure that their technical documentation contains all required information, as prescribed by the adopted Order No. 11n dated 19 January 2017. This technical documentation is to be submitted as a part of a registration dossier for any medical devices.

Russia. Issue 5 January 2017

Amended rules for importing pharmaceuticals into Russia

According to the amendment, all pharmaceuticals (both registered and not registered in Russia) may be imported into Russia without a permit (issued by the Ministry of Healthcare), provided that they are intended to be used for private purposes by individuals arriving into Russia.

Russia: proposed legal framework for marking products with identification marks

The Ministry of Finance has proposed draft law that would require certain products (the exact lists of these products are to be adopted at a later stage) with special identification and tracking marks (RFID).

The declared aims of this requirement are to protect the consumer from counterfeit and illegally imported or manufactured products and to unify the procedure of product tracking.