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2.8.2012 Official
Journal
of
the
European
Union L
207/27
DECISION OF THE EEA JOINT COMMITTEE
No 47/2012
of 30 March 2012
amending Annex II (Technical regulations, standards, testing and certification) to the EEA
Agreement
THE EEA JOINT COMMITTEE,
(EC) No 1394/2007 of the European Parliament and
of the Council with regard to the evaluation and
Having regard to the Agreement on the European Economic
certification of quality and non-clinical data relating
Area, as amended by the Protocol adjusting the Agreement
to advanced therapy medicinal products developed by
on the European Economic Area, hereinafter referred to as
micro, small and medium-sized enterprises (OJ L 194,
‘the Agreement’, and in particular Article 98 thereof,
25.7.2009, p. 7)’.
Whereas:
Article 2
The text of Regulation (EC) No 668/2009 in the Icelandic and
(1) Annex
II
to
the
Agreement
was
amended
by
Decision
of Norwegian languages, to be published in the EEA Supplement
the EEA Joint Committee No 10/2012 of 10 February
to the Official Journal of the European Union, shall be authentic.
2012 ( 1 ).
Article 3
(2) Commission
Regulation
(EC)
No
668/2009
of
24
July
2009 implementing Regulation (EC) No 1394/2007 of
This Decision shall enter into force on 31 March 2012,
the European Parliament and of the Council with regard
provided that all the notifications under Article 103(1) of the
to the evaluation and certification of quality and non-
Agreement have been made to the EEA Joint Committee (*).
clinical data relating to advanced therapy medicinal
products developed by micro, small and medium-sized
Article 4
enterprises ( 2 ) is to be incorporated into the Agreement,
This Decision shall be published in the EEA Section of, and in
the EEA Supplement to, the Official Journal of the European
HAS ADOPTED THIS DECISION:
Union.
Article 1
The following point shall be inserted after point 15zl (Com
Done at Brussels, 30 March 2012.
mission Decision 2008/911/EC) in Chapter XIII of Annex II to
the Agreement:
For the EEA Joint Committee
‘15zm. 32009 R 0668: Commission Regulation (EC) No
The Acting President
668/2009 of 24 July 2009 implementing Regulation
Gianluca GRIPPA
( 1 ) OJ L 161, 21.6.2012, p. 16.
( 2 ) OJ L 194, 25.7.2009, p. 7. (*)
No
constitutional
requirements
indicated.

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