Manufacturers of veterinary drugs in the Russian Federation must obtain permits to put vaccines into circulation

“From September of this year, No. 317-FZ comes into force, according to which all immunobiological preparations must have permission to be put into civil circulation. What are the conditions for obtaining this permit? it is issued by ROSSELKHOZNADZOR . To do this, you need to send documents to the department: confirmation of an authorized person that the vaccine is of high quality, a quality certificate, GMP and a research protocol,” explained Vasylina Gritsyuk, speaking at the international exhibition “Meat Industry. Chicken king. Refrigeration industry for the agro-industrial complex / MAP RUSSIA & VIV.

She added that it is necessary to obtain permission to put into civil circulation for domestic and foreign vaccines, as well as for immunobiological preparations that move through the country. The procedure for issuing a permit differs depending on whether the drug has previously been marketed on the Russian market. “There are vaccines that have been on the Russian market for a long time. They also need to obtain permission to enter into civil circulation. But for such vaccines, only one protocol per lot needs to be submitted. The protocol can be issued by a certified organization subordinate to the Ministry of Agriculture or Rosselkhoznadzor,” explained Vasilina Gritsyuk. She added that the protocols can be obtained now so that there are no delays in September.

“Pharmaceuticals enter the civil circulation in the usual way. Manufacturers of these drugs submit the same documents in a notification manner to the Rosselkhoznadzor information system,” said Vasilina Gritsyuk.

The same vaccines and pharmaceuticals that are introduced to the Russian market for the first time must be tested twice in accredited laboratories. “Permission must be issued for the first two batches of this drug, after which the manufacturer can obtain permission to put it into civil circulation for a period of three years,” the deputy DIRECTOR of the institution emphasized.

The expert also drew the attention of manufacturers to the need to annually submit to the Rosselkhoznadzor the protocols for testing medicines in all doses and packaging that were released in the previous period by February 1. These studies are also carried out in accredited laboratories.