Amendments (variations) and re-registration
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
There are two types of amendments – A and B – differing by the significance of introduced changes. Procedure of making amendments is made as a complete expert evaluation procedure equivalent to a new registration procedure.
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. If the re-registration is conducted to prolongate the registration, the procedure is streamlined.
“VetConsult” assists in arrangement of making amendments and re-registration of veterinary products. We help you to compile a package of necessary documents and arrange the conduct of the state re-registration up to the registration certificate issue.
Budget and duration of re-registration can vary greatly depending on the amendment content, product type, completeness of the dossier, language of the documents and need for translation, etc.
The budget and period of re-registration will be stated following the request indicating the product(s) you are going to reregister 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.