(Utkast) Kommisjonens gjennomføringsforordning (EU) .../... om endring av gjennomføringsforordning (EU) 2021/17 med hensyn til inkludering av en endring om endring av distributørens kontaktinformasjon i listen over endringer som ikke krever vurdering
Veterinærlegemiddelforordningen 2019: endringsbestemmelser i listen over godkjenningskrav som ikke krever vurdering
(Draft) Commission Implementing Regulation (EU) .../... amending Implementing Regulation (EU) 2021/17 as regards the inclusion of a variation amending the contact details of the distributor in the list of variations not requiring assessment
Utkast til kommisjonsforordning godkjent av komite (representanter for medlemslandene) og publisert i EUs komitologiregister 3.3.2026
Bakgrunn
(fra kommisjonsforordningen)
(1) Commission Implementing Regulation (EU) 2021/172 establishes a list of variations not requiring assessment in accordance with Regulation (EU) 2019/6.
(2) Based upon experience gained, the Coordination Group on Veterinary Medicinal Products advised the Commission to amend one of the entries in the Annex to Regulation (EU) 2021/17 in order to include in the list of variations not requiring assessment a variation amending the contact details of the distributor(s).
(3) The Commission agrees that this type of variation does not require an assessment, as such change is of an administrative nature and does not require a scientific assessment.
(4) Implementing Regulation (EU) 2021/17 should therefore be amended accordingly.
(5) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Veterinary Medicinal Products,