The main change is the reduction of processing time from 45 to 35 business days.
Besides that, when changes, connected with the replacement of auxiliary substances and packaging materials are applied to an authorized feed additive, a notification procedure will be introduced.
The simplified national authorization procedure will be in place until March 1, 2023.
“This will allow to reduce the extent of administrative burden for manufacturers of such products, speed up the introduction of the product to the market and prevent disruptions in functioning of such an important sector of animal husbandry,” says a statement published at the government’s website.
The list of animal health products subject to accelerated authorization procedure (60 business days) is expanded by the same Decree.
Reminder: the accelerated national authorization procedure for veterinary medicines was established by another Decree of the government (#353) for the purpose of import substitution. The time of approval process has been reduced from 160 to 60 business days. This measure has been in effect since March 2022.
From now on, the list of veterinary medicines subject to accelerated authorization procedures will also include domestic substitutes for foreign-made animal health products. Besides that, the number of documents required for authorization of veterinary medicines is being reduced.
This document was developed jointly by the Ministry of Agriculture and Rosselkhoznadzor, taking into account the comments received from domestic manufacturers, as Konstantin Savenkov, Deputy Head of Rosselkhoznadzor, previously told V&L.
“We put some collaborative effort into considering opportunities for simplification and reduction in the regulatory framework. We understand that a number of laboratory tests can’t be reduced, but some processing procedures can. We managed to find a compromise with the business without any loss in quality,” said Konstantin Savenkov in a comment.
In addition, until September 1, 2023, an accelerated procedure for testing laboratories accreditation will apply. From now on it will be limited to 30 business days instead of 61 business days, as it used to be. According to the Cabinet of Ministers, this measure will reduce the extent of administrative burden for laboratories and will allow them to start researching new products in a short time.
