Back to EUR-Lex homepage

EUR-Lex Access to European Union law

Back to EUR-Lex homepage

This document is an excerpt from the EUR-Lex website

Use quotation marks to search for an "exact phrase". Append an asterisk (*) to a search term to find variations of it (transp*, 32019R*). Use a question mark (?) instead of a single character in your search term to find variations of it (ca?e finds case, cane, care).
Search tips
Need more search options? Use the Advanced search
You are here

Document 32023R0997

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)

C/2023/3254

OJ L 136, 24.5.2023, p. 1–3 (BG, ES, CS, DA, DE, ET, EL, EN, FR, GA, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)

Legal status of the document In force

ELI: http://data.europa.eu/eli/reg_impl/2023/997/oj

Date of document:
23/05/2023; Date of adoption
Date of effect:
13/06/2023; Entry into force Date pub. +20 See Art 2
Date of end of validity:
No end date
Author:
European Commission, Directorate-General for Health and Food Safety
Responsible body:
Directorate-General for Health and Food Safety, SANTE
Form:
Implementing regulation
Additional information:
EEA relevance
Treaty:
Treaty on the Functioning of the European Union
Legal basis:
Link
Link
Link
Select all documents mentioning this document
Modifies:
Relation Act Comment Subdivision concerned From To
Modifies 32021R0017 Addition annex point B point 12 point (h) 13/06/2023
Modifies 32021R0017 Replacement annex point B point 24 13/06/2023
Link

24.5.2023   

EN

Official Journal of the European Union

L 136/1

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 60(1) 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 60(2) 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,

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.

Done at Brussels, 23 May 2023.

For the Commission

The President

Ursula VON DER LEYEN

(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).

ANNEX

In the Annex to Implementing Regulation (EU) 2021/17, point B is amended as follows:

(1)

in point 12, the following point is added:

‘h)

—

to production equipment (when described in the dossier) including processes related to the equipment

The change shall not result in any changes or modifications of the production process or quality of the product.

Amendment of the relevant section(s) of the dossier.’

(2)

point 24 is replaced by the following:

‘24

Replacement or addition of a manufacturer responsible for:

The manufacturer or the site shall already be introduced in the Union IT systems storing and providing organisational data.

The site shall be appropriately authorised and satisfactorily inspected.

Amendment of the relevant section(s) of the dossier, including revised product information, as appropriate.

Qualified person (QP) declaration.’

a)

—

batch release including batch control or testing of a sterile or non-sterile finished product

The change shall not be applicable to a biological or immunological medicinal product.

Method transfer from the former to the new site shall have been successfully completed.

 

b)

—

batch release not including batch control or testing of a sterile or non-sterile finished product

At least one batch control/testing site remains within the EEA or in a country where an operational and suitably scoped GMP mutual recognition agreement (MRA) exists between the country concerned and the EU, that is able to carry out product testing for the purpose of batch release within the EEA.

 
Top