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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

Division 1.2 Simplified IMPD by referring to other documentation

United Kingdom

Original text. Later amendments are not shown.

50Division 50
Possibility of referring to the IB
Possibility of referring to the SmPC

← Division 49

Division 1.2

Division 50 →

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 1.2
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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