Registration of veterinary medicines in Belarus

28.09.2015

AKVET Consulting offers its services in registration and promotion of veterinary products. We carry out registration of veterinary medicines in Belarus. Our experts will help you to obtain the registration certificate in shortest possible time and will build an effective strategy for successful sales of your products.

Registration of veterinary medicines in the Republic of Belarus

All the veterinary medicinal products, intended for sale and use on the territory of the Republic of Belarus, subject to the state registration, namely:

  • New (with the original composition) veterinary medicines;
  • Generic medicines, bioequivalent to already registered ones, but produced by another manufacturer or in collaboration with another manufacturer;
  • Veterinary medicines manufactured or registered in other countries and intended to be used on the territory of the Republic of Belarus.

Veterinary drugs, registered by the Head Department of Veterinary Medicine are allowed for use.

Without registration it is only allowed to use diagnostic kits, veterinary drugs used for treatment and disease prevention for pets, as well as veterinary medicines, which have already been scientifically tested and used for field trials in accordance with research program of a particular medicine, agreed with the Head Department of Veterinary Medicine.

List of documents for registration of veterinary medicines

To register a new product (first created) veterinary medicine, the applicant must provide:

  1. The application form for registration of veterinary product;
  2. Information about analogous products and statement of need of production of the medicine;
  3. The report on the experimental studies of the veterinary drug, including a detailed description of the research methods, with the description if the sensitivity, the tested dosage and results obtained. The report on the study of biological veterinary drug should contain the information about the properties of used strains of microorganisms (fungi, bacteria, viruses), culture techniques, immunological potencies, safety, methods and timing of application, therapeutic efficacy, possible side effects, timing of use of the animal products after application.

    The report on the study of veterinary chemotherapeutic drugs should contain information on the toxicity, the specific activity, pharmacodynamics and pharmacokinetics, timing of use of the animal products after application.

    Veterinary preparations are divided into 9 groups, depending on the volume of the necessary studies:

    • Original, new drugs that have not previously used in veterinary. Multiple studies must be carried out for such drugs. These include the toxicity studies in two species of farm and laboratory animals, the specific activity, pharmacodynamics and pharmacokinetics invitro and invivo experiments, storage stability, duration of preslaughter holding after using the product.

    • Products used in human medicine and are recommended for use in veterinary medicine. Study conducted the same as in the first group, except for toxicity studies in laboratory animals and specific toxicity;

    • New drugs, containing the active substances and excipients, approved for use in veterinary. In testing of these drugs on laboratory animals, chronic toxicity is to be revealed. Also, the pharmacokinetics, maximum tolerated dose, pharmacodynamics, therapeutic efficacy must be determined.

    • Veterinary drugs, already known, with a new recommended route of administration: medicines recommended for oral parenteral, intracisternal, intrauterine administration, which are studied with different methods.

    • Veterinary drugs already known to be recommended for other animal species subject to studies similar to the third group except the study of chronic and acute toxicity in laboratory animals.

    • Already known drugs, recommended for use with new timing and dosage.

    • Already known drugs, recommended for the new indications.

    • Already known drugs with a new excipients, allowed for use in veterinary medicine. In this case the studies on the specific activity, acute toxicity in laboratory animals are carried out. Animal products usage procedures are to be determined.

    • Medicines, similar to generics produced in Belarus, if their composition is not protected by the relevant patent.

  4. Report on storage stability of the veterinary medicinal product.
  5. Product description and a list of components and materials included in composition>
  6. Draft of the recommendations for use.
  7. Draft of Technological Regulations with the justification of the selected methods, and conducted quality control tests.
  8. Samples of the veterinary drugs in consumer packaging in the quantities enough for testing.
  9. Manufacturer's document confirming the quality of veterinary drugs.
  10. Standard samples of the active ingredients.

When registration or re-registration of veterinary drugs used in the Republic of Belarus or registered in another country, the applicant must provide the following documents:

  • Product description with a list of components used and included into composition;

  • The document confirming registration in Belarus or any other country;

  • The documents confirming the efficacy, the properties, the safety of the product;

  • Technological Regulations or declaration of composition (for foreign applicants) with the established quality indicators and methods of their control;

  • Product samples in commodity packaging;

  • The document, confirming the product quality;

  • Standard samples of the active ingredients (if needed).


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