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Official Journal of the European Union
24.1.2013
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,
pursuant to Article 111b of Directive 2001/83/EC, the
requirements set out in points (a) to (d) of Article 111b(1)
Having regard to the Treaty on the Functioning of the European
shall be applied as follows:
Union,
(a) in applying point (a) of Article 111b(1), the Commission
Having regard to Directive 2001/83/EC of the European
shall take into account the applicable guidelines referred to
Parliament and of the Council of 6 November 2001 on the
in the second paragraph of Article 47 of Directive
Community Code relating to medicinal products for human
2001/83/EC;
use ( 1 ), and in particular Article 111b(2) thereof,
(b) in applying point (b) of Article 111b(1), the Commission
Whereas:
shall take into account the applicable guidelines referred to
in Article 3(1) of Commission Directive 2003/94/EC of
(1) Article
111b(1)
of
Directive
2001/83/EC
specifies
the
8 October 2003 laying down the principles and guidelines
aspects of which the Commission must take particular
of good manufacturing practice in respect of medicinal
account when assessing whether a third country’s regu
products for human use and investigational medicinal
latory framework applicable to active substances
products for human use (
exported to the Union and the respective control and

2 );
enforcement activities ensure a level of protection of
(c) in applying point (c) of Article 111b(1), the Commission
public health equivalent to that of the Union.
shall assess inspection resources, the qualification and
training of inspectors, inspection procedures, inspection
(2) It
should
be
set
out
in
more
detail
which
aspects
and
strategies and mechanisms to address conflicts of interest,
respective EU documents are taken into account when
inspection performance standards, enforcement powers,
conducting the equivalence assessment in accordance
alert and crisis mechanisms, and analytical capacity taking
with Article 111b(1) of Directive 2001/83/EC.
into account the applicable guidelines referred to in
(3) The
measures
provided
for
in
this
Decision
are
in
Article 3(1) of Directive 2003/94/EC;
accordance with the opinion of the Standing
(d) in applying point (d) of Article 111b(1), the Commission
Committee on Medicinal Products for Human Use,
shall assess the third country’s arrangements in order to
HAS ADOPTED THIS DECISION:
ensure regular and rapid provision of information by the
third country to the EU in relation to non-compliant
Article 1
producers of active substances.
This Decision specifies how the aspects referred to in points (a)
Article 3
to (d) of Article 111b(1) of Directive 2001/83/EC are to be
assessed for the purposes of determining whether a third
This Decision shall enter into force on the twentieth day
country’s regulatory framework applicable to active substances
following that of its publication in the Official Journal of the
exported to the Union and the respective control and
European Union.
enforcement activities ensure a level of protection of public
health equivalent to that of the Union.
Done at Brussels, 23 January 2013.
Article 2
For the purposes of assessing the equivalence of the level of
For the Commission
protection of public health ensured by a third country’s regu
latory framework applicable to active substances exported to the
The President
Union and the respective control and enforcement activities
José Manuel BARROSO
( 1 ) OJ L 311, 28.11.2001, p. 67.
( 2 ) OJ L 262, 14.10.2003, p. 22.

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