State Registration of Veterinary Medicinal Products and Feed Additives: Legal Basis and Requirements

In the Russian Federation, the circulation of veterinary medicinal products is governed by Federal Law No. 61‑FZ “On the Circulation of Medicines” (adopted 12 April 2010). The law makes state registration mandatory for every veterinary drug or feed additive before market entry.

Under Order of the Ministry of Agriculture of Russia dated 1 April 2005, the Federal Service for Veterinary and Phytosanitary Surveillance (Rosselkhoznadzor) registers the following categories:

• Innovative (original) products and additives
• Modified versions of existing medicines and feed additives
• Products with altered characteristics (new dosage, excipient profile, or dosage form)
• Generic (reproduced) products and additives

The registration procedure is complex and time‑consuming, largely because applicants must compile and submit a substantial dossier for expert review. Professional guidance helps optimise timelines and reduce the risk of refusal.

Document Package Required under Article 18 of Law 61‑FZ

Main documents:

• Application form in the prescribed format (two copies)
• Comprehensive registration dossier

The dossier must contain:

1. Packaging mock‑ups

• Designs of primary containers
• Consumer‑level packaging options

2. Proof of manufacturing compliance

• For Russian firms: valid manufacturing licence
• For foreign firms: GMP, ISO, or CCP certificates with certified translation

3. Regulatory‑technical documentation

• Draft normative document, or
• Reference to an applicable pharmacopoeial monograph

4. Manufacturing documentation

• Detailed description of the technological process
• Flow diagrams for finished‑product and API production

5. Substance documentation

• Manufacturer’s GMP compliance certificate
• Certified translation for foreign producers

6. Pharmaceutical substance passport

• International Non‑proprietary Name (INN)
• Chemical name
• Trade name
• Manufacturer details (name and production address)
• Declared shelf‑life of the substance

7. Specification of active‑ingredient quality attributes

8. Technical documentation on the active substance or reference to the relevant pharmacopoeial section

9. Product handling regulations

• Storage conditions
• Transport rules
• Other significant information

10. Research documentation

Pre‑clinical studies:

• Stability data under storage conditions
• Toxicological profile (animal studies): acute, sub‑acute, sub‑chronic, and chronic toxicity
• Metabolism and residue‑depletion data

Clinical studies:

• Evidence of therapeutic efficacy
• Justification of claimed indications

11. Draft instructions for use

Three signed copies and three unsigned copies

12. Certificate of foreign registration (if applicable)

Russian translation with notarisation

13. Payment documents

Confirmation of state‑fee payment for:

• Quality assessment
• Benefit–risk evaluation

Dossier Formatting Requirements

• Sequential page numbering
• Detailed inventory in duplicate
• Page count indicated for every document
• Page numbers clearly marked

Additional Conditions

• Compliance with current regulatory acts
• Use of approved evaluation methods for:

– Product efficacy
– Component safety
– Additive quality

All materials are submitted to Rosselkhoznadzor in the prescribed manner.

Our Company’s Registration Support Services

Permit documentation for veterinary medicines

• Obtaining registration certificates for feed additives
• Registering active pharmaceutical ingredients
• Updating existing registration dossiers
• Extending validity of registration certificates
• Establishing pharmacovigilance and safety monitoring
• Creating technical and regulatory documentation

Indicative Registration Timelines

• Veterinary medicinal products: 9 – 12 months
• Feed additives: 6 – 8 months

Main Work Stages

• Organisation and conduct of required studies
• Compilation of a complete registration package
• Interface with supervisory authorities
• Support of expert review at the FGFI “VGNKI”
• Receipt of final authorising documents

The professional experience of our specialists enables us to solve every challenge arising during registration of veterinary medicines and feed additives, applying well‑tested algorithms at each stage.