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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/ECnote, and in particular Article 60(1) thereof,Whereas:
(1)Commission Implementing Regulation (EU) 2021/17note 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,
HAS ADOPTED THIS REGULATION:
Article 1#
The Annex to Implementing Regulation (EU) 2021/17 is amended in accordance with the Annex to this Regulation.
Article 2#
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.This Regulation shall be binding in its entirety and directly applicable in all Member States.
In the Annex to Implementing Regulation (EU) 2021/17, in part C, point (a) of entry 10 ‘Changes to the labelling or the package leaflet which shall not be connected with the SPC:’ is replaced by the following:
note‘a)
—administrative information concerning the holder’s representative or the distributor(s)note
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