Annexes to COM(2023)295 - Delegated acts of the Commission under Regulation 2019/6 on veterinary medicinal products (‘VMP Regulation’) - Main contents
Please note
This page contains a limited version of this dossier in the EU Monitor.
| dossier | COM(2023)295 - Delegated acts of the Commission under Regulation 2019/6 on veterinary medicinal products (‘VMP Regulation’). |
|---|---|
| document | COM(2023)295 |
| date | June 7, 2023 |
- Commission Delegated Regulation (EU) 2021/1760 of 26 May 2021 supplementing Regulation (EU) 2019/6 of the European Parliament and of the Council by establishing the criteria for the designation of antimicrobials to be reserved for the treatment of certain infections in humans9. This act, adopted on the basis of Article 37(4) of Regulation (EU) 2019/6, entered into force on 26 October 2021 and entered into application on 28 January 2022.
- Commission Delegated Regulation (EU) 2023/183 of 23 November 2022 amending Regulation (EU) 2019/6 of the European Parliament and of the Council as regards the requirements on compliance with good laboratory practice for veterinary medicinal products set out in Annex II to that Regulation10. This act, adopted on the basis of Article 146(1) of Regulation (EU) 2019/6, entered into force on 19 February 2023 and entered into application on 28 January 2022.
- Commission Delegated Regulation (EU) 2023/905 of 27 February 2023 supplementing Regulation (EU) 2019/6 of the European Parliament and of the Council as regards the application of the prohibition of use of certain antimicrobial medicinal products in animals or products of animal origin exported from third countries into the Union11. This act was adopted on the basis of Article 118(2) of Regulation (EU) 2019/6.
The Commission notified each of the aforementioned delegated acts to the European Parliament and to the Council, in accordance with Article 147(6) of Regulation (EU) 2019/6. The European Parliament and the Council did not extend the objection period referred to in Article 147(7) of Regulation (EU) 2019/6 in relation to any of these acts, with the exception of Commission Delegated Regulation (EU) 2021/1760 of 26 May 2021 supplementing Regulation (EU) 2019/6 of the European Parliament and of the Council by establishing the criteria for the designation of antimicrobials to be reserved for the treatment of certain infections in humans. The European Parliament extended the objection period by two months with respect to the latter act. Neither the European Parliament nor the Council objected to any of the above acts in accordance with Article 147(7) of Regulation (EU) 2019/6.
The Commission has so far used 6 out of the 9 empowerments in Article 147(2) of Regulation (EU) 2019/6 and which are therefore within the scope of this report.
3.2. EMPOWERMENTS NOT USED DURING THE REPORTING PERIOD
Certain empowerments of Regulation (EU) 2019/6 have not been used during the reporting period for the reasons explained below.
- Article 106(6)
The Commission is currently preparing a delegated act laying down rules on appropriate measures to ensure the effective and safe use of veterinary medicinal products authorised and prescribed for oral administration via routes other than medicated feed and administered by the animal keeper to food-producing animals, in accordance with Article 106(6) of Regulation (EU) 2019/6.
- Article 115(3)
There is currently no new scientific evidence reported regarding the areas covered by paragraphs 1 to 4 of Article 115 of Regulation (EU) 2019/6. However, future changes and developments may require proceeding with the preparation of a delegated act pursuant to Article 115(3).
- Article 136(7)
The Commission has not yet started preparing a delegated act under Article 136(7) of Regulation (EU) 2019/6, as the focus so far has been on empowerments with specific deadlines. However, it will proceed with preparation of a delegated act in due course.
CONCLUSION
The Commission sees the need for a tacit extension of the delegation of power provided for in Article 147(2) of Regulation (EU) 2019/6 for a period of five years, in accordance with that Article. This is due to the fact that the need to develop rules based on the empowerments granted by Article 147(2) of Regulation (EU) 2019/6 will remain in the future. This will be particularly important to provide the necessary flexibility in the new legal framework, to complement and adjust it regularly to the latest scientific standards and to allow the Commission to act in the areas where it did not act until now, but will need to do so in the future.
With this report, the Commission complies with the reporting requirements established in Article 147(2) of Regulation (EU) 2019/6.
The Commission invites the European Parliament and the Council to take note of this report.
1 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 (OJ L4, 7.1.2019, p. 43).
2 Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Commmunity code relating to veterinary medicinal products (OJ L 311, 28.11.2001, p. 1). Directive 2001/82/EC applied to nationally authorised products. The previous rules for centrally authorised products were set out in Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ L 136, 30.4.2004, p.1), Regulation (EC) No 1901/2006 on medicinal products for paediatric use (OJ L 378, 27.12.2006, p. 1) and Directive 2001/83/EC on the Community code relating to medicinal products for human use (OJ L 311, 28.11.2001, p. 67). Regulation (EU) 2019/5 of the European Parliament and of the Council of 11 December 2018 amending Regulation (EC) No 726/2004 (OJ L4, 7.1.2019, p. 24) repealed the provisions of Regulation (EC) No 726/2004 concerning the authorisation of veterinary medicinal products, as Regulation (EU) 2019/6 brings together rules for both nationally and centrally authorised products.
3 The cut-off date for the inclusion in this section of delegated acts adopted during the reporting period is 28 April 2023.
4 The delegated acts are listed in the chronological order of their date of adoption.
5 OJ L 123 9.4.2021, p. 3.
6 Commission Delegated Regulation (EU) 2022/524 of 27 January 2022 correcting Delegated Regulation (EU) 2021/577 as regards certain references to veterinary medicinal products; OJ L 105, 4.4.2022, p. 1.
7 OJ L 123, 9.4.2021, p. 7.
8 OJ L 180, 21.5.2021, p. 3.
9 OJ L 353, 6.10.2021, p. 1.
10 OJ L 26, 30.1.2023, p.7.
11 OJ L 116, 04.05.2023, p.1.
EN EN