Autorizarea produselor medicinale veterinar în contextul noilor reglementari Europene / nationale

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 treate...

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Bibliographic Details
Main Author: Nica Andrei-George
Format: Article
Language:English
Published: Asociaţia Naţională a Fabricanţilor de Produse de Uz Veterinar 2022-06-01
Series:Medicamentul Veterinar
Subjects:
Online Access:http://www.veterinarypharmacon.com/docs/2409-2022_VD_16(1)_ART.4.ROM.pdf
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Summary: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.
ISSN:1843-9527
2069-2463