Ressources numériques en sciences humaines et sociales OpenEdition Nos plateformes OpenEdition Books OpenEdition Journals Hypothèses Calenda Bibliothèques OpenEdition Freemium Suivez-nous

European Commission – Labelling requirements for IMPs amended (Regulatory Round-up – September 2022)

Following a 1-month feedback period on the draft published in June this year the European Commission (EC) adopted on 6 September the revised Annex VI to Regulation (EU) No 536/2014 (Clinical Trials Regulation, CTR) as regards labelling requirements for IMPs. The Regulation will enter into force on the twentieth day following its publication in the Official Journal of the European Union and will be binding and directly applicable in all Member States.

More information is provided under Unauthorised medicinal products used in clinical trials (labelling rules).

See all of the Gene and Cell Catapult’s regulatory round-up for september 2022 here. Published on the 4th of October 2022.


OpenEdition vous propose de citer ce billet de la manière suivante :
adelage (30 novembre 2022). European Commission – Labelling requirements for IMPs amended (Regulatory Round-up – September 2022). ELSIBI. Consulté le 16 mars 2026 à l’adresse https://doi.org/10.58079/o65j


Vous aimerez aussi...

Laisser un commentaire

Votre adresse e-mail ne sera pas publiée. Les champs obligatoires sont indiqués avec *

This site uses Akismet to reduce spam. Learn how your comment data is processed.