EN    EN  
 EUROPEAN COMMISSION 
Brussels, XXX   
[…](2012) XXX  draft 
  
COMMISSION IMPLEMENTING DECISION 
of XXX  
on the assessment of a thir d country’s regulatory framew ork applicable to active 
substances of medicinal products for human use and of the respective control and 
enforcement activities pursua nt to Article 111b of Directive 2001/83/EC of the European 
Parliament and of the Council 
(Text with EEA relevance) 
  
EN 2   EN COMMISSION IMPLEMENTING DECISION 
of XXX  
on the assessment of a third country’s reg ulatory framework applicable to active 
substances of medicinal products for hum an 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) 
THE EUROPEAN COMMISSION, 
Having regard to the Treaty on the Functioning of the European Union, Having regard to Directive 2001/83/EC of the Eu ropean Parliament and of the Council of 28 
November 2001 on the Community Code relati ng to medicinal products for human use
1, and 
in particular Article 111b(2) thereof, 
Whereas: (1) Article 111b(1) of Direct ive 2001/83/EC specifies the aspects of which the 
Commission must take partic ular account when assessing whether a third country’s 
regulatory framework applicable to active s ubstances 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 whic h 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 Medicina l Products for Human Use, 
HAS ADOPTED THIS DECISION: 
Article 1 
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 ac tive substances exported to the Union and the 
respective control and enforcement activities en sure a level of protection of public health 
equivalent to that of the Union. 
Article 2 
For the purposes of assessing th e 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 enfo rcement activities pursu ant to Article 111b of 
                                                
 
1  OJ L 311, 28.11.2001, p. 67.  
EN 3   EN Directive 2001/83/EC, the requireme nts set out in points (a) to (d ) of Article 111b(1) shall be 
applied as follows: 
(a) 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. 
(b) 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 th e principles and guidelines of good 
manufacturing practice in respect of medicinal products for human use and 
investigational medicinal products for human use.2 
(c) In applying point (c) of Article 111b(1) , the Commission shall assess inspection 
resources, the qualificati on and training of inspecto rs, 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 re ferred to in Article 
3(1) of Directive 2003/94/EC. 
(d) 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-comp liant producers of active 
substances. 
Article 3 
This Decision shall enter into force on the twentieth day following that of its publication in 
the Official Journal of  the European Union . 
Done at Brussels,  
 For the Commission 
 The President  […] 
                                                
 
2 OJ L 262, 14.10.2003, p. 22.