# 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), Article 88: Committee procedure

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

1. The Commission shall be assisted by the Standing Committee on Medicinal Products for Human Use established by Directive 2001/83/EC. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011.
2. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply.
Where the committee delivers no opinion, the Commission shall not adopt the draft implementing act and the third subparagraph of Article 5(4) of Regulation (EU) No 182/2011 shall apply.

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Source: https://www.legislation.gov.uk/eur/2014/536/article/88 (the official version)
Page: https://openlegislation.uk/eu-regulation-2014-536/article-88
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.