TITLE XI

SUPERVISION AND SANCTIONS
Article 111b
1
At the request of a third country, the Commission shall assess whether that 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. If the assessment confirms such equivalence, the Commission shall adopt a decision to include the third
country in a list. The assessment shall take the form of a review of relevant documentation and, unless arrangements as referred to in Article 51(2) of this Directive are in place that cover this area of activity, that assessment shall include an on-site review of the third country’s regulatory system and, if necessary, an observed inspection of one or more of the third country’s manufacturing sites for active substances. In the assessment particular account shall be taken of:
a
the country’s rules for good manufacturing practice;
b
the regularity of inspections to verify compliance with good manufacturing practice;
c
the effectiveness of enforcement of good manufacturing practice;
d
the regularity and rapidity of information provided by the third country relating to non-compliant producers of active substances.
2
The Commission shall adopt the necessary implementing acts to apply the requirements set out in points (a) to (d) of paragraph 1 of this Article. Those implementing acts shall be adopted in accordance with the procedure referred to in Article 121(2).
3
The Commission shall verify regularly whether the conditions laid down in paragraph 1 are fulfilled. The first verification shall take place no later than 3 years after the country has been included in the list referred to in paragraph 1.
4
The Commission shall perform the assessment and verification referred to in paragraphs 1 and 3 in cooperation with the Agency and the competent authorities of the Member States.
Inserted by Directive 2011/62/EU of the European Parliament and of the Council of 8 June 2011 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, as regards the prevention of the entry into the legal supply chain of falsified medicinal products (Text with EEA relevance).