New registration of a veterinary product
A new registration is conducted by the State Committee of Veterinary based on carried out examinations in authorized institutions, laboratories and designated bases.
List of necessary documents, duration, schedule of expert reviews and budget of an individual procedure of a new registration procedure can differ significantly depending on product characteristics (veterinary medicine, immunobiological product, fodder supplement, premix, etc.), availability of registered analogs and other conditions.
State registration includes the following stages:
- preparation of documents according to the legal requirements;
- submission of an Application and the documents to an expert body;
- initial inspection of the Application and submitted documentation package (completeness);
- specialized examination of the documents;
- laboratory analysis of samples;
- specialized examination (as necessary) including:
- toxicological testing;
- residual quantities testing;
- clinical epidemical studies;
- production site inspection(as necessary);
- approval of the product for registration at expert body meeting;
- issuing of the original of registration certificate;
The list of necessary document (registration dossier) differs depending on the product type:
- Dossier structure for registration of veterinary medicines;
- Dossier structure for registration of finished fodder for unproductive animals;
- Dossier structure for registration of fodder supplements and premixes;
- Dossier structure for registration of veterinary immunobiological products;
- Dossier structure for registration of veterinary substances;
- Dossier structure for registration of veterinary diagnostic products;
Registration dossier should be presented in English, Russian or Ukrainian. If the dossier is in English, Russian or Ukrainian versions are obligatory.
Vetconsult assists in arrangement of veterinary products registration. We help you to compile a package of necessary documents, develop an Application and Appendices and arrange the conduct of the state registration, all expert examinations and tests under Power of Attorney up to the registration certificate issue.
We will be engaged in the following activities in the course of veterinary products registration:
- Providing all necessary preliminary consultations;
- Assisting in compiling of registration dossier;
- Translating the documents in Russian or Ukrainian as necessary;
- Compiling a draft application, development Normative Analytical Documentation and the other specific documents;
- Submitting the document to the state bodies;
- Arrangement of documentary expert evaluation;
- Obtaining authorization and import of product samples and standards for laboratory analysis;
- Arrangement of laboratory analysis;
- Arrangement of other necessary expert evaluations (residual quantities, toxicology, clinical studies);
- Preparation of all documents for approval of the product at a meeting;
- Reading and harmonizing of draft registration certificate;
- Obtaining the original document and sending them to you.
Budget and duration of registration can vary greatly depending on the product type and list of the products registered at the same time, completeness of the dossier, language of the documents and need for translation.
The budget and period of registration will be stated following the request indicating the product(s) you are going to register and initial check of your dossier by the specialists of our company. We will definitely sign a Confidential Disclosure Agreement to obtain and check the dossier!
To discuss further information concerning registration and any other issues call +38 (044) 384-48-69 or write reg@vetconsult.com.ua.