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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 III
Division 2
Division 2.2

Division 9

United Kingdom

Original text. Later amendments are not shown.

If information on expectedness has been provided by the reporting investigator, this shall be taken into consideration by the sponsor.

Division 9

Division 2.3 →

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 9
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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