2013/51/EU: 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

24.1.2013 EN Official Journal of the European Union L 21/36
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)
THE EUROPEAN COMMISSION
,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community Code relating to medicinal products for human use (1), and in particular Article 111b(2) thereof,
Whereas:
(1) Article 111b(1) of Directive 2001/83/EC specifies the aspects of which the Commission must take particular account when assessing 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.
(2) It should be set out in more detail which aspects and respective EU documents are taken into account when conducting the equivalence assessment in accordance with Article 111b(1) of Directive 2001/83/EC.
(3) The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on Medicinal Products for Human Use,