# Commission Implementing Decision of 23 January 2013 on the assessment of a third country’s regulatory framework applicable to active substances of medicinal products for human use and of the respective control and enforcement activities pursuant to Article 111b of Directive 2001/83/EC of the European Parliament and of the Council (Text with EEA relevance) (2013/51/EU), Article 1

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

This Decision specifies how the aspects referred to in points (a) to (d) of Article 111b(1) of Directive 2001/83/EC are to be assessed for the purposes of determining whether a third country’s regulatory framework applicable to active substances exported to the Union and the respective control and enforcement activities ensure a level of protection of public health equivalent to that of the Union.

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Source: https://www.legislation.gov.uk/eudn/2013/51/article/1 (the official version)
Page: https://openlegislation.uk/eu-decision-2013-51/article-1
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.