General information about certification of medicines
Within the framework of the EAEU, there is no single Technical Regulation for the certification of medicines. In Russia, mandatory certification or declaration of medicines is carried out within the framework of federal legislation by the authorized bodies for certification of medicinal products by certification bodies in the system of certification of Rosstandart of Russia - GOST R.
In addition to the procedure for certification of medicines in the GOST R system, they should also undergo a compulsory and rather complicated procedure for state registration.
Medicines that are subjects to obligatory GOST R certification and declaration
GOST R Certification procedure is obligatory for:
Immuno-, gamma globulins, serums, blood preparations and other genetically engineered products and biological substrates used in medicine;
Anatoxins, toxins, vaccines used in medicine;
Used in veterinary anatoxins and vaccines.
GOST R Declaration procedure is obligatory for:
- Medicines and chemical-pharmaceutical products;
Ofermenty and enzymes, amino acids and vitamins, organopreparations;
Serums, obtained by genetic engineering, blood preparations used in veterinary medicine.
Contact us, and our experts will help you determine the necessary requirements for certification, declaration, registration of your products, as well as organize a procedure for state registration of medicines.