[Hybrid medicines in France. Hybrid medicines: Genesis and legal framework in Europe and in France].

Les médicaments hybrides en France. Genèse des médicaments hybrides et cadre règlementaire en Europe et en France.
Drugs, Generic Europe France Marketing
Cadre juridique Code de la santé publique Dossier d’autorisation de mise sur le marché French public health code Hybrid medicines Hybrid medicines groups’ register Legal framework Marketing authorization applications Médicaments hybrides Registre des groupes hybrides

Journal

Annales pharmaceutiques francaises
ISSN: 0003-4509
Titre abrégé: Ann Pharm Fr
Pays: France
ID NLM: 2985176R

Informations de publication

Date de publication:
Nov 2021
Historique:
received: 15 11 2020
revised: 28 03 2021
accepted: 05 04 2021
pubmed: 8 5 2021
medline: 16 11 2021
entrez: 7 5 2021
Statut: ppublish

Résumé

Hybrid medicines are defined as medicines that do not fill generic medicines' definition, forming a medicines group that stands half-way between reference medicinal products and generic medicines. The term "hybrid" was introduced in France in 2018, but the concept has existed for some fifteen years in Community legislation. The aim of this work is to expose hybrid medicines' legal framework, in Europe and in France. Hybrid medicines' European legal framework specifies in a guide of the European Medicines Agency, marketing authorization procedures that can be used for hybrid medicines, and what is required for marketing authorization applications. In France, a register of hybrid medicines' groups has been created, and registration procedures were specified in a decree at the end of 2019. Legal texts also underlined that substitution within hybrid medicines' group would be possible for some specific medical cases. Decrees specifying hybrid medicines' groups list and specific medical cases allowing substitution, are not appeared yet at the end of February 2021. Moreover, some elements have never been raised, particularly medical and economic assessment modalities.

Identifiants

DOI: 10.1016/j.pharma.2021.04.007 PMID: 33961828
pubmed: 33961828
pii: S0003-4509(21)00067-5
doi: 10.1016/j.pharma.2021.04.007
pii:
doi:

Substances chimiques

Drugs, Generic 0

Types de publication

Journal Article

Langues

fre

Sous-ensembles de citation

IM

Pagination

609-616

Informations de copyright

Copyright © 2021 Académie Nationale de Pharmacie. Published by Elsevier Masson SAS. All rights reserved.

Auteurs

E Leclerc (E)

Agence générale des équipements et produits de santé (AGEPS), AP-HP, 7, rue du Fer-à-Moulin, 75005 Paris, France. Electronic address: lec.elisabeth@gmail.com.

I Fusier (I)

Agence générale des équipements et produits de santé (AGEPS), AP-HP, 7, rue du Fer-à-Moulin, 75005 Paris, France.

P Paubel (P)

Agence générale des équipements et produits de santé (AGEPS), AP-HP, 7, rue du Fer-à-Moulin, 75005 Paris, France; Faculté de pharmacie, université de Paris, 4, avenue de l'Observatoire, 75006 Paris, France; Institut droit et santé, Inserm UMRS 1145, université de Paris, 45, rue des Saints-Pères, 75006 Paris, France.

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Classifications MeSH

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