For the purposes of assessing the equivalence of the level of protection of public health ensured by a third country’s regulatory framework applicable to active substances exported to the Union and the respective control and enforcement activities pursuant to Article 111b of Directive 2001/83/EC, the requirements set out in points (a) to (d) of Article 111b(1) shall be applied as follows:
in applying point (a) of Article 111b(1), the Commission shall take into account the applicable guidelines referred to in the second paragraph of Article 47 of Directive 2001/83/EC;
in applying point (b) of Article 111b(1), the Commission shall take into account the applicable guidelines referred to in Article 3(1) of Commission Directive 2003/94/EC of 8 October 2003 laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use(1);
in applying point (c) of Article 111b(1), the Commission shall assess inspection resources, the qualification and training of inspectors, inspection procedures, inspection strategies and mechanisms to address conflicts of interest, inspection performance standards, enforcement powers, alert and crisis mechanisms, and analytical capacity taking into account the applicable guidelines referred to in Article 3(1) of Directive 2003/94/EC;
in applying point (d) of Article 111b(1), the Commission shall assess the third country’s arrangements in order to ensure regular and rapid provision of information by the third country to the EU in relation to non-compliant producers of active substances.