Autorizarea produselor medicinale veterinar în contextul noilor reglementari Europene / nationale

Abstract

The presentation is an update of the aspects specific to the connection/adoption of the Romanian legislation of the field to that of the EU, respectively EU Regulation 2019/6, of the EU Parliament and of the Council of 11 December 2018, regarding veterinary medicinal products, where they have treated Article 6: Submission of applications for marketing authorizations; Art. 46: Scope of the marketing authorization granted by national procedure, Art. 47: National procedure for granting marketing authorization. It also presents the possible advantages of a national legislative procedure as well as proposals to ease the process of changing the conditions of authorization and variations that require evaluation, as a means of advising small and medium enterprises.

Keywords

• a.u.v. drug
• authorization
• u.e. regulations