# 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), Division 5

Extent: E+W+S+N.I.

Without prejudice to Article 26, the application dossier for an application limited to Part II of the assessment report referred to in Article 11 and the application dossier for an application referred to in Article 14 shall be limited to sections K to R of this Annex.

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Source: https://www.legislation.gov.uk/eur/2014/536/annex/I/division/A/division/5 (the official version)
Page: https://openlegislation.uk/eu-regulation-2014-536/annex-I/division-A/division-5
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.