New Rules for the Circulation of Veterinary Medicinal Products: Key Points for Businesses

New regulations governing the circulation of veterinary medicinal products have entered into force. These rules affect manufacturers, importers, distributors, retailers of veterinary medicines, as well as feed market operators.

Below are the key requirements businesses should be aware of.

1. Only Registered Veterinary Medicines May Circulate

Only veterinary medicinal products that have undergone state registration may be placed on the market. Information about registered products is published in the State Register of Veterinary Medicinal Products.

Certain exceptions exist for medicines intended for specific categories of pets (such as ornamental fish, cage birds, small rodents, terrarium animals, etc.), provided that these animals are not used for food production.

2. Rules for Medicated Feed

Medicated feed may be supplied to animal owners only if it corresponds to a veterinary prescription.

Feed market operators involved in the production, storage, transportation, or sale of medicated feed must implement measures to prevent contamination of other feed with active substances contained in veterinary medicinal products and comply with established cross-contamination limits.

Operators selling medicated feed must hold a license for wholesale or retail distribution of veterinary medicinal products.

3. Packaging, Advertising and Licensing

Veterinary medicinal products circulating on the market must be accompanied by clear and complete package leaflets in the official language.

Advertising of veterinary medicines must comply with applicable advertising legislation.

Business activities involving the wholesale distribution and retail sale of veterinary medicinal products are subject to licensing.

4. Distance Selling

Retail sale of veterinary medicinal products via distance selling (e.g., online) is allowed only for market operators that:

• are established and registered in accordance with applicable law;

• hold a license for retail sale of veterinary medicinal products;

• are included in the official register of operators authorized to sell veterinary medicines remotely.

However, distance selling of veterinary medicines that require a veterinary prescription is prohibited.

5. Veterinary Prescriptions

Veterinary medicinal products must be dispensed based on a veterinary prescription when such a requirement is specified in the product’s registration decision.

Prescriptions may be issued in paper or electronic form.

A veterinary prescription must include, among other things:

• identification of the animal or group of animals;

• details of the animal’s owner or keeper;

• information about the veterinarian issuing the prescription;

• the name of the medicinal product and its active substances;

• dosage form and strength;

• dosage instructions;

• withdrawal period for food-producing animals (where applicable).

A veterinary prescription for antimicrobial veterinary medicines is valid for five days from the date of issuance.

6. Supply Chain and Compliance Requirements

Retail operators must obtain veterinary medicinal products exclusively from licensed wholesale distributors.

In addition, market operators must:

• maintain records of veterinary medicinal products;

• conduct internal audits at least once per year;

• implement pharmacovigilance procedures;

• appoint a responsible person for pharmacovigilance.

7. Disposal of Expired or Defective Products

Expired or substandard veterinary medicinal products must be properly disposed of in accordance with applicable regulations.

8. Registration of Market Operators

Market operators involved in the circulation of veterinary medicinal products must be registered in the official register of market operators.

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