Commission Delegated Regulation (EU) 2022/524 of 27 January 2022 correcting Delegated Regulation (EU) 2021/577 as regards certain references to veterinary medicinal products (Text with EEA relevance)
Date: 2022-01-27
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: animal health, equidae, exchange of information, health certificate, health control, market approval, marketing standard, medicinal product, pharmaceutical legislation, veterinary inspection, veterinary medicinal product








L_2022105EN.01000101.xml










4.4.2022   


EN


Official Journal of the European Union


L 105/1








            COMMISSION DELEGATED REGULATION (EU) 2022/524
of 27 January 2022
         
correcting Delegated Regulation (EU) 2021/577 as regards certain references to veterinary medicinal products
(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 109(1) thereof,

Whereas:







(1)


The error appears in all language versions of the text of recital (4), as well as point (1)(a) and points (2)(a) and (b) of Annex I and point (1)(c)(ii) of Annex II to Commission Delegated Regulation (EU) 2021/577 (2), as regards the erroneous use of the word ’veterinary‘ where the text is to be related both to veterinary medicinal products and medicinal products for human use. Therefore, the term ‘medicinal product’ should be used, encompassing both of those products.












(2)


Delegated Regulation (EU) 2021/577 should therefore be corrected accordingly.












(3)


This Regulation should be applicable from 28 January 2022 in accordance with the date of application of Regulation (EU) 2021/577.












(4)


In accordance with Article 147(5) of Regulation (EU) 2019/6, the Commission has consulted experts designated by each Member State,





HAS ADOPTED THIS REGULATION:



Article 1
Delegated Regulation (EU) 2021/577 is corrected as follows:






(1)


Annex I is corrected as follows:






(a)


point (1)(a) is replaced by the following:






‘(a)


contact details of the signing veterinarian responsible who treated the equine animal concerned with a veterinary medicinal product authorised under the exemption provided for in Article 8(4) of Regulation (EU) 2019/6 or a medicinal product administered in accordance with Article 112(4) of that Regulation’;














(b)


point (2)(a) and (b) are replaced by the following:






‘(a)


contact details of the signing veterinarian responsible who administered a medicinal product containing a substance included in the list established in accordance with Article 115(5) of Regulation (EU) 2019/6;










(b)


date and place of the last administration of the medicinal product referred to in point (a) to the equine animal concerned;’;


















(2)


in Annex II, point (1)(c)(ii) is replaced by the following:






‘(ii)


to document the date of last administration of a medicinal product containing a substance included in the list established in accordance with Article 115(5) of Regulation (EU) 2019/6, and details of that substance.’.










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.
It shall apply from 28 January 2022.




This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 27 January 2022.


For the Commission


The President

Ursula VON DER LEYEN
            





(1)  
            OJ L 4, 7.1.2019, p. 43.

(2)  Commission Delegated Regulation (EU) 2021/577 of 29 January 2021 supplementing Regulation (EU) 2019/6 of the European Parliament and of the Council as regards the content and format of the information necessary to apply Articles 112(4) and 115(5) and to be contained in the single lifetime identification document referred to in Article 8(4) of that Regulation (OJ L 123, 9.4.2021, p. 3).