Dear applicants and holders of certificates of compliance!

The certification of the fgbi "VGNKI" informs that in accordance with the decree of the Government of the Russian Federation 24.04.2019 № 489 "On amendments to resolution of the Government of the Russian Federation from 01.12.2009 № 982" with 29.11.2019 registration mandatory certificate of conformity for medicinal products for veterinary use will not be possible. There will also be the abolition of compulsory confirmation of conformity of products in the form of registration of the Declaration of conformity for some types of products used in veterinary medicine. Recommend you become more familiar with the provisions of this resolution of the Government of the Russian Federation and the Federal law of 28.11.2018 No. 449-FZ.

The certification of the fgbi "VGNKI" emphasizes the need to consider this information when submitting applications for certification of products and applications for the registration of declarations of conformity.

For reference:

In accordance with the provisions of the Federal law from 28.11.2018 No. 449-FZ "On amendments to certain legislative acts of the Russian Federation on the issue of putting into civil circulation of medicinal preparations for medical use" with 29.11.2019 amends the Federal law of 27.12.2002 № 184-FZ "On technical regulation" to exclude medicinal means from the sphere of technical regulation.

With 29.11.2019 enters into force the decree of the Government of the Russian Federation "On amendments to resolution of the Government of the Russian Federation from 01.12.2009 № 982" in terms of exclusion from the unified list of products subject to mandatory certification section 9384 "Vaccine and toxoids used in veterinary medicine"as well as the exclusion from the unified list of products, conformity assessment which takes the form of a Declaration of conformity, sections 9300 "Medicines, chemical and pharmaceutical products and products of medical appointment", 9350 "Vitamins, coenzymes, enzymes, amino acids, organ (endocrine preparations)", 9382 "Serum, blood products and obtained by genetic engineering, used in veterinary medicine", 9386 "Bacteriophages (including bacteriophages for veterinary use)", 9387 "Allergens (including allergens for veterinary use)", 9389 "Serum antibodies and other diagnostic products used in medicine".