Veterinærlegemiddelforordningen 2019: endringsbestemmelser om kravene til overholdelse av god laboratoriepraksis

Tittel

(Utkast) Delegert kommisjonsforordning (EU) .../... 23. november 2022 om endring av europaparlaments- og rådsforordning (EU) 2019/6 med hensyn til kravene til overholdelse av god laboratoriepraksis for veterinærpreparater i vedlegg II til nevnte forordning

(Draft) Commission Delegated Regulation (EU) .../... 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

Siste nytt

Utkast til delegert kommisjonsforordning sendt til Europaparlamentet og Rådet for klarering 23.11.2022

Nærmere omtale

BAKGRUNN (fra kommisjonsforordningen, engelsk utgave)

(1) Certain references to requirements for pre-clinical studies set out in Annex II to Regulation (EU) 2019/6 need to be adapted to reflect the fact that compliance with good laboratory practice is not required in relation to efficacy studies, but only for safety studies. Part I.1.6, point I.2.3.(1)(b), point I.2.4.(2)(b), point IIIb.3A(2) and point IIIb.4B.(4)(b) of Annex II to Regulation (EU) 2019/6 should be adapted accordingly, thus ensuring that the provisions on compliance with good laboratory practice are applied correctly. The European Medicines Agency has been consulted.

(2) Regulation (EU) 2019/6 should therefore be amended accordingly.

(3) Since Annex II to Regulation (EU) 2019/6, as replaced by Commission Delegated Regulation (EU) 2021/805 has applied since 28 January 2022, this Regulation should also apply from that date in order to avoid unnecessary repetition of pharmacological, toxicological, residue and pre-clinical safety studies conducted with respect to applications for marketing authorisations submitted before the entry into force of this Regulation.

Nøkkelinformasjon

EU



eu-flagg
Dokument (forberedende)
Kommisjonens framlegg
Dato
23.11.2022

Norge



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Ansvarlig departement
Helse- og omsorgsdepartementet