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GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 15 (7) - (10) +
Application for ethics committee opinion
15.— (7) If—
(a)any subject to the clinical trial is to be an adult incapable by reason of physical and ment… +
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EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 66 Paragraph 1 +
Application for performance studies
1. The sponsor of a performance study referred to in Article 58(1) and (2) shall enter and submit an applicatio… +
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Approved bodies and the conformity assessment procedures for general medical devices
18.—(1) An approved body which is responsible for carrying out a… +
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Archiving of the clinical trial master file
Unless other Union law requires archiving for a longer period, the sponsor and the investigator shall arc… +
EU Directive 2001/83/EC - Community code relating to medicinal products for human use 20-Jun-12 Article 107n +
Article 107n
1. Before a study is conducted, the marketing authorisation holder shall submit a draft protocol to the Pharmacovigilance Risk Assessm… +
EU Regulation (EC) No 726/2004 - authorisation and supervision of medicinal products for human use 28-Jan-22 Article 26 +
Article 26
1. The Agency shall, in collaboration with the Member States and the Commission, set up and maintain a European medicines web-portal [EU… +
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FRA Code de la Santé Publique - Partie législative - 1ere partie, Livre 1er, Titre II 16-May-2025 L5311-1 +
Article L5311
I.-L'Agence nationale de sécurité du médicament et des produits de santé est un établissement public de l'Etat, placé sous la tutelle du… +
FRA Code de la Santé Publique - Partie Réglementaire - 1ere partie, Livre 1er, Titre II 16-May-2025 Article R1121-3-1 +
Article R1121-3-1
I.-Lorsqu'une recherche mentionnée au 1° et au 2° de l'article L. 1121-1 à finalité commerciale est réalisée dans des établissement… +
FRA Code de la Santé Publique - Partie Réglementaire - 1ere partie, Livre 1er, Titre II 16-May-2025 Article R1123-20 +
Article R1123-20
I. – La demande d'avis sur un projet de recherche impliquant la personne humaine est déposée par le promoteur sur le système d'infor… +
FRA Code de la Santé Publique - Partie Réglementaire - 1ere partie, Livre 1er, Titre II 16-May-2025 Article R1123-20-1 +
Article R1123-20-1
I.-Un système d'information des recherches impliquant la personne humaine permet :
1° Les échanges entre les promoteurs et les co… +
FRA Code de la Santé Publique - Partie Réglementaire - 1ere partie, Livre 1er, Titre II 16-May-2025 R1123-46 +
Article R1123-46
Pour l'application de la présente section, on entend par :
[…]
12° Pour les recherches impliquant la personne humaine, fait nouveau :… +
FRA Code de la Santé Publique - Partie Réglementaire - 1ere partie, Livre 1er, Titre II 16-May-2025 R1123-53 +
Article R1123-53
Pour les recherches mentionnées au 1° de l'article L. 1121-1 autres que celles mentionnées aux articles R. 1123-54 à R. 1123-58, le … +
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Assessment of a substantial modification of an aspect covered by Part I of the assessment report
1. The reporting Member State shall assess the app… +
Assessment of a substantial modification of aspects covered by Parts I and II of the assessment report — Assessment of the aspects covered by Part II … +
Assessment report — Aspects covered by Part II
1. Each Member State concerned shall assess, for its own territory, the application with respect to … +
Assessment report — Aspects covered by Part I
1. The reporting Member State shall assess the application […]
(a) Whether the clinical trial is a l… +
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Audit
A systematic and independent examination of trial-related activities and records performed by the sponsor, service provider (including contract … +
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Authorisation procedure for clinical trials involving medicinal products for gene therapy etc.
[…]
Authorisation procedure for clinical trials involvi… +
Authorisation procedure for clinical trials involving general medicinal products
18.—(1) This regulation applies to clinical trials involving medicina… +
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Authorised investigational and authorised auxiliary medicinal products
1. Authorised investigational medicinal products and authorised auxiliary me… +
