Markedsføringstillatelser for legemidler til mennesker: endringsbestemmelser
(Under forberedelse) Delegert kommisjonsforordning (EU) .../... om endringer i markedsføringstillatelser (Revisjon av variasjonsrammeverket for legemidler)
(In preparation) Commission Delegated Regulation (EU) .../... Pharmaceuticals – changes to marketing authorisations (Revision of the variation framework for medicines)
Notat om planlagt forordning lagt fram av Kommisjonen 29.8.2023 med tilbakemeldingsfrist 26.9.2023
Nærmere omtale
BAKGRUNN (fra Kommisjonens initiativ av 29.8.2023)
Pharmaceuticals – changes to marketing authorisations (review of EU rules)
This initiative, announced in the 2020 pharmaceutical strategy for Europe, aims to review the current rules setting out the procedures for post-authorisation changes to a marketing authorisation for medicines for human use. The purpose is to make the lifecycle management of medicines more efficient.
Call for evidence
Feedback period: 29 August 2023 - 26 September 2023
Call for evidence - Ares(2023)5859980
Pharmaceuticals – changes to marketing authorisations (review of EU rules)
This initiative, announced in the 2020 pharmaceutical strategy for Europe, aims to review the current rules setting out the procedures for post-authorisation changes to a marketing authorisation for medicines for human use. The purpose is to make the lifecycle management of medicines more efficient.
Call for evidence
Feedback period: 29 August 2023 - 26 September 2023
Call for evidence - Ares(2023)5859980