Amendments to Lists of Products Subject to Mandatory Certification.

03.04.2012

Legal Update No. 341

Goltsblat BLP advises that, by its Resolution No. 213 of 21 March 2012, the Russian Government has amended the lists of products subject to mandatory certification and of those compliance by which is confirmed by a compliance declaration. These amendments come into effect on 26 May 2012.

In particular, in accordance with the amendments, vaccines and anatoxins used in veterinary medicine became subject to mandatory certification (their compliance used to be confirmed by compliance declaration). The list of products subject to mandatory certification has been clarified in relation to sections 9381 (serum, immuno- and gamma-globulin, blood preparations: other and those produced by means of genetic engineering and other biological substrata used in medicine) and 9383 (vaccines, anatoxins and toxins used in medicine).

Certain sections, including section 2537 "Medical, Sanitary and Hygienic Products and Moulded Patient Care Items" (this group includes medical products made of rubber, polymers, latex and glass), are excluded from the unified list of products compliance by which used to be confirmed by compliance declaration. So, effective 26 May 2012, products excluded from the list should not be appraised under the Federal Law "On Technical Regulation". Even so, compliance by certain non-moulded medical products still has to be confirmed by compliance declaration. The list of products compliance by which is to be confirmed by compliance declaration was also amended in relation to sections 9385 - 9387 (nutrient microbiological medium, nutrient bases and biological materials for virological culture media used in medicine, bacteriophages, including bacteriophages for veterinary medicine; allergies, including allergies to veterinary medicine).

Compliance certificates and declarations issued before these amendments come into effect are recognised as valid during the term specified therein or the service or operating life of the products. Products and (or) packaging released for circulation throughout the territory of the Russian Federation in accordance with the specified documents are not subject to compliance mark re-labelling.

For additional information, please contact:

to Nina Belozertseva
Head of Healthcare & Pharmaceuticals,
Goltsblat BLP
T: +7 (495) 287 44 44,
E: info@gblplaw.com

to Alexander Muravin
Junior Assosiate,
Goltsblat BLP
T: +7 (495) 287 44 44,
E: info@gblplaw.com

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