Kommisjonens gjennomføringsforordning (EU) 2024/916 av 26, mars 2024 om endring av gjennomføringsforordning (EU) 2021/17 om opprettelse av liste over endringer som ikke krever vurdering, i samsvar med europaparlaments- og rådsforordning (EU) 2019/6
Veterinærlegemiddelforordningen 2019: endringer i liste over godkjenningskrav som ikke krever vurdering
Kommisjonsforordning publisert i EU-tidende 27.3.2024
Tidligere
- Utkast til kommisjonsforordning godkjent av komite (representanter for medlemslandene) og publisert i EUs komitologiregister 28.2.2024
Nærmere omtale
BAKGRUNN (fra kommisjonsforordningen)
(1) Commission Implementing Regulation (EU) 2021/17 sets out a list of variations not requiring assessment.
(2) Commission Implementing Regulation (EU) [OP: please insert the reference to PLAN/2023/921] sets out a list of abbreviations and pictograms common throughout the Union to be used on the packaging of veterinary medicinal products for the purposes of Article 10(2) and Article 11(3) of Regulation (EU) 2019/6. Veterinary medicinal products authorised before the date of application of that Regulation might not contain such abbreviations or pictograms or might contain abbreviations or pictograms that do not yet comply with the requirements established therein, and therefore require a variation of the terms of the marketing authorisation. Such variations do not require any scientific assessment and should be included in the Annex to Regulation (EU) 2021/17.
(3) Commission Implementing Regulation (EU) [OP: please insert the reference to PLAN/2023/922] sets out uniform rules on the size of small immediate packaging units of veterinary medicinal products. Veterinary medicinal products authorised before the date of application of that Regulation might not yet comply with the requirements established therein, and therefore require a variation of the terms of the marketing authorisation. Such variations do not require any scientific assessment and should be included in the Annex to Regulation (EU) 2021/17.
(4) The Commission has taken into account all necessary conditions to be fulfilled for the variation to be classified as a variation not requiring assessment and the documentation to be submitted with the application for the variation not requiring assessment. In order to ensure the good use of the veterinary medicinal product, the listing as a variation not requiring assessment should be conditional on the addition not having an impact on the readability of the label.
(5) Regulation (EU) 2021/17 should therefore be amended accordingly.
(6) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Veterinary Medicinal Products,