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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 G INVESTIGATIONAL MEDICINAL PRODUCT DOSSIER (IMPD)

United Kingdom

Original text. Later amendments are not shown.

36Division 36
1.1Data relating to the investigational medicinal product
1.2Simplified IMPD by referring to other documentation
1.3IMPD in cases of placebo

← Division 35

Division G

Division 36 →

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 g
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.

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