State Registration System
The state registration system of veterinary products is determined by Law of Ukraine “On Veterinary Medicine”, article 17. The objects of the state registration are the following:
- veterinary medicines;
- veterinary immunobiological products;
- substances for veterinary products manufacture;
- veterinary diagnostic products;
- antiseptics, disinfectants, insectoacaricides and deratization agents employed in animal production and veterinary medicine;
- fodder supplements, premix and finished fodder.
Therefore, the state registration is obligatory for marketing of veterinary medicines imported to Ukraine or manufactured in Ukraine.
New registration. State registration is conducted by the State Committee of Veterinary based on carried out examinations in authorized institutions, laboratories and designated bases.
Registration Certificate valid for 5 years is issued following favorable conclusions on documents and product samples expert examination.
Registration Certificate, a document confirming the state registration of veterinary medicines and their use in animal production, is issued in the name of Applicant (i.е. holder of this registration), includes information about manufacturer, registered products and their characteristics.
Amendments. The need for amendments can arise during Registration Certificate term of validity. Such amendments are documented by the re-registration procedure of a veterinary product; as a result the modified certificate is issued.
Re-registration. Application for product re-registration is possible upon the expiration of Registration Certificate to prolongate the registration for the next period. The documents for re-registration should be submitted no later than 90 days before registration expiration.
State fees. The Applicant will pay to state expert bodies for all activities in the course of registration and re-registration related to expert examination of registration documents, laboratory analysis of quality parameters and other assessments under contracts. The cost is composed depending on characteristics of a product, its group, country of origin and other characteristics of a specific product.
Safety monitoring. Following receipt of the Registration Certificate of a veterinary product the Registration Certificate Holder takes an obligation to submit information concerning adverse events and non-specific drug actions. Consolidated safety reports should be submitted within the period established by law from the date of product registration in Ukraine.
Legislation. The system of state registration of veterinary medicines is regulated by a great number of legal acts of different relevance.
To discuss further information concerning registration and any other issues call +38 (044) 384-48-69 or write reg@vetconsult.com.ua.