1. solis /
Applicant / Marketing Authorisation Holder will submit a properly drawn up a submission with the necessary documentation, the FVS in a specified time period shall be carried out within the framework of the documentation submitted by the inspection and shall take a decision regarding registration of veterinary medicinal products for which shall inform the applicant.
- applicants registration shall attach documents that contain administrative information and scientific documentation necessary to prove to be registered in the veterinary medicinal product safety, efficacy and quality of the 18.07.2006. The Cabinet of Ministers No 600 "procedures for the Registration of Medicinal Products for Veterinary Medicinal Products% quot% 2. the Annex (neimunoloģiskajām relating to veterinary medicinal products), Annex 3 (in the case of immunological veterinary medicinal products), 3.1 or 3.2. the requirements referred to in the Annex.
Documents to be submitted