# 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 16: Submission of application

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

In order to obtain an authorisation, the sponsor shall submit an application dossier to the Member States concerned through the EU portal.

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Source: https://www.legislation.gov.uk/eur/2014/536/article/16 (the official version)
Page: https://openlegislation.uk/eu-regulation-2014-536/article-16
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.