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.
Pharma and medical devices
Adopted Code of Conduct for storage and transportation of pharmaceutical products
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.
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.
Adopted Technical Regulation on the Safety of Pharmaceuticals
Amended Technical Regulation on the Safety of Machinery and Equipment (TR TS 010/2011)
The list of products subject to conformity assessment in a form of certification has been amended to exclude “Technological equipment for trading facilities and public catering facilities”.
The list of products subject to conformity assessment in a form of issuing a Declaration of Conformity has been revised to include:
The Working Group on creation of common approach to regulating market circulation of pharmaceuticals has approved a number of necessary documents. These documents are required for the launch of the common pharmaceuticals market in Eurasian Economic Union member states (Belarus, Kazakhstan, Russia, Armenia and Kyrgyzstan).
On 4 August 2016 the text of the draft Technical Regulation (TR) on the Restriction of Hazardous Substances in Electrical and Electronic Equipment has been published. The text is in line with the European Directive 2011/65/EU (RoHS 2). The provisions of the TR would apply to the whole EEU: Russia, Belarus, Kazakhstan, Armenia and Kyrgyzstan.
Draft Customs Code of the EEU is to be submitted for intra-state approval in August 2016
On 26 July 2016 the High Level Working Group dealing with draft Customs Code of the EEU has managed to find an agreement between the parties on the text of the draft Code.