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Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (Text with EEA relevance)
Annex I

Division D PROTOCOL

United Kingdom

Original text. Later amendments are not shown.

14Division 14
15The protocol shall be identified by:
16Division 16
17The protocol shall at least include:
18Division 18
19With regard to the notification of adverse events, the protocol shall identify the categories of:
20The protocol shall describe the procedures for:
21Division 21
22Division 22
23Division 23
24Division 24

← Division 13

Division D

Division 14 →

Legislation: Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (Text with EEA relevance)
Citation: EU Regulation No 536/2014, division d
Official version: legislation.gov.uk

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Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives. legislation.gov.uk is the official version.

Not legal advice.

👋 Jason Cartwright
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