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 Regulation (Text with EEA relevance)

• CELEX: Delegated Regulation (EU) 2023/183
• Articles: 3

Article 1

Annex II to Regulation (EU) 2019/6 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 .

It shall apply from 28 January 2022.

Schedules & Appendices

ANNEX

ANNEX

Annex II to Regulation (EU) 2019/6 is amended as follows:

(1)

point I.1.6 is replaced by the following:

I.1.6

‘Pharmacological, toxicological, residue and pre-clinical safety studies shall be carried out in conformity with the provisions related to Good Laboratory Practice (GLP) laid down in Directives 2004/10/EC  ( * ) and 2004/9/EC  ( ** ) of the European Parliament and of the Council;

( * )   Directive 2004/10/EC of the European Parliament and of the Council of 11 February 2004 on the harmonisation of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances ( OJ L 50, 20.2.2004, p. 44 )."

( ** )   Directive 2004/9/EC of the European Parliament and of the Council of 11 February 2004 on the inspection and verification of good laboratory practice (GLP) ( OJ L 50, 20.2.2004, p. 28 ).’

"

(2)

in point I.2.3(1), subpoint (b) is replaced by the following:

‘(b)

statement of compliance with GLP for pre-clinical safety studies, where applicable, together with a discussion of the contribution that any non-GLP study may make to the overall risk assessment, and justification of non-GLP status’;

(3)

in point I.2.4(2), subpoint (b) is replaced by the following:

‘(b)

a statement of compliance with GLP for pre-clinical safety studies, where applicable, together with a discussion of the contribution that any non-GLP study may make to the overall risk assessment, and justification of non-GLP status’;

(4)

in point IIIb.3A, subpoint (2) is replaced by the following:

‘(2)

Pre-clinical safety studies shall be carried out in compliance with GLP requirements.

Non-GLP studies may be accepted for non-target species studies as well as studies evaluating immunological, biological or genetic properties of the vaccine strains, under adequately controlled conditions. Other deviations shall be justified’;

(5)

in point IIIb.4B, subpoint (4)(b) is deleted.

( * )   Directive 2004/10/EC of the European Parliament and of the Council of 11 February 2004 on the harmonisation of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances ( OJ L 50, 20.2.2004, p. 44 ).

( ** )   Directive 2004/9/EC of the European Parliament and of the Council of 11 February 2004 on the inspection and verification of good laboratory practice (GLP) ( OJ L 50, 20.2.2004, p. 28 ).’

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