Diario Oficial de la Unión Europea del 24/5/2023 - Sección Legislación
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Fuente: Diario Oficial de la Unión Europea - Sección Legislación
EN
24.5.2023
Official Journal of the European Union
L 136/1
II
Non-legislative acts
REGULATIONS
COMMISSION IMPLEMENTING REGULATION EU 2023/997
of 23 May 2023
amending Implementing Regulation EU 2021/17 establishing a list of variations not requiring assessment in accordance with Regulation EU 2019/6 of the European Parliament and of the Council Text with EEA relevance
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union, Having regard to Regulation EU 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC 1, and in particular Article 601 thereof, Whereas:
1
Commission Implementing Regulation EU 2021/17 2 sets out a list of variations not requiring assessment.
2
The European Medicines Agency the Agency and the Coordination Group on Veterinary Medicinal Products CMDv advised the Commission, on 20 December 2022, to amend points B.12 and B.24 of the Annex to Implementing Regulation EU 2021/17 to reflect new developments. Both the Agency and the CMDv received requests for classification of three changes to the terms of a marketing authorisation not listed in the Annex to Implementing Regulation EU 2021/17 that had not arisen before as variations not requiring assessment. These changes concern production equipment or processes related to production equipment, and changes in relation to the manufacturer responsible for batch release.
3
The Commission took into account the advice of the Agency and the CMDv, the criteria listed in Article 602 of Regulation EU 2019/6, as well as all necessary conditions and the most current documentation requirements, to ensure that the new variations not requiring assessment do not present a risk to public health, animal health or the environment.
4
Implementing Regulation EU 2021/17 should therefore be amended accordingly to include these new types of variations currently not listed in the Annex to that Implementing Regulation.
5
The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Veterinary Medicinal Products,
1 OJ L 4, 7.1.2019, p. 43.
2 Commission Implementing Regulation EU 2021/17 of 8 January 2021 establishing a list of variations not requiring assessment in accordance with Regulation EU 2019/6 of the European Parliament and of the Council OJ L 7, 11.1.2021, p. 22.
