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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 E

Division 25

United Kingdom

Original text. Later amendments are not shown.

An IB, which has been prepared in accordance with the state of scientific knowledge and international guidance, shall be submitted.

Division 25

Division 26 →

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 25
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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