New requirements are applied  for manufacturers of veterinary drugs

New requirements are applied for manufacturers of veterinary drugs

Qualification, organizational, technological and personnel requirements, that are mandatory for manufacturers of veterinary drugs,  are introduced

The relevant licensing conditions of economic activities for the production of veterinary drugs are approved by the Cabinet of Ministers Order No. 808 on October 3, 2018, which entered into force on December 19.

The production of veterinary drugs is carried out on the basis of a license, for which the manufacturer submits an application and the following documents to the State Foodstuffs Service:

1) supporting documents for each place of economic activity for the production of veterinary drugs:

– information of the business entity on the availability of material and technical base and the availability of specialists with educational and qualification levels necessary to carry out economic activities for the production of veterinary drugs;

– a copy of the file of the site of the manufacturer of veterinary drugs, approved by a business entity;

2) a copy of the passport of the head of the license applicant (his authorized representative);

3) information about the lack of control (in the sense given in Article 1 of the Law on the Protection of Economic Competition) for the activities of a license applicant for residents of other states engaged in armed aggression against Ukraine and / or whose actions create conditions for the occurrence of military conflict and military force against Ukraine. Such information is submitted in any form;

4) an inventory of the submitted documents in duplicate.

The licensee should have its own or rented premises, the material and technical base, the staffing level of specialists of the appropriate level of training and the regulatory and technical documentation for the production of veterinary drugs.

The license conditions set the technological requirements for production, requirements for premises and equipment, as well as personnel.

In particular, the FLP should have a degree in Veterinary Medicine, and a legal entity must have at least one specialist in veterinary medicine.

Specialists in veterinary medicine undergo advanced training at least once every five years.

Also, the license conditions set the obligation to formalize employment relationships with the staff by entering into employment contracts in accordance with the provisions of the Labor Code.

The Cabinet of Ministers in March determined the Gosprodpotrebsluzhba  (State Consumer Service Institution) a licensing authority for the production of veterinary drugs. The main requirements for the production of veterinary drugs are regulated by the order of the Ministry of Agrarian Policy No. 606 of November 10, 2017.