HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"L 262/28
EN
Official Journal of the European Union
6.10.2011
DECISION OF THE EEA JOINT COMMITTEE
No 72/2011
of 1 July 2011
amending Annex II (Technical regulations, standards, testing and certification) to the EEA
Agreement
THE EEA JOINT COMMITTEE,
(1) the text of point 4 (Council Directive 78/25/EEC) shall be
replaced by the following:
Having regard to the Agreement on the European Economic
Area, as amended by the Protocol adjusting the Agreement
on the European Economic Area, hereinafter referred to as
‘32009 L 0035: Directive 2009/35/EC of the European
‘the Agreement’, and in particular Article 98 thereof,
Parliament and of the Council of 23 April 2009 on the
colouring matters which may be added to medicinal
products (OJ L 109, 30.4.2009, p. 10).’;
Whereas:
(1) Annex
II
to
the
Agreement
was
amended
by
Decision
of (2) the following indent shall be added in point 15h (Council
the EEA Joint Committee No 25/2010 of 12 March
Regulation (EC) No 297/95):
2010 ( 1 ).
‘— 32009 R 0249: Commission Regulation (EC) No
(2) Commission
Regulation
(EC)
No
249/2009
of
23
March
249/2009 of 23 March 2009 (OJ L 79, 25.3.2009,
2009 amending Council Regulation (EC) No 297/95 as
p. 34).’;
regards the adjustment of the fees of the European
Medicines Agency to the inflation rate ( 2 ) is to be incor
porated into the Agreement.
(3) the following indent shall be added in point 15p (Directive
2001/82/EC of the European Parliament and of the
(3) Directive
2009/35/EC
of
the
European
Parliament
and
of
Council):
the Council of 23 April 2009 on the colouring matters
which may be added to medicinal products ( 3 ) is to be
incorporated into the Agreement.
‘— 32009 L 0053: Directive 2009/53/EC of the European
Parliament and of the Council of 18 June 2009 (OJ
L 168, 30.6.2009, p. 33).’;
(4) Directive
2009/53/EC
of
the
European
Parliament
and
of
the Council of 18 June 2009 amending Directive
2001/82/EC and Directive 2001/83/EC, as regards
(4) the following indents shall be added in point 15q (Directive
variations to the terms of marketing authorisations for
2001/83/EC of the European Parliament and of the
medicinal products ( 4 ) is to be incorporated into the
Council):
Agreement.
(5) Commission
Directive
2009/120/EC
of
14
September
‘— 32009 L 0053: Directive 2009/53/EC of the European
2009 amending Directive 2001/83/EC of the European
Parliament and of the Council of 18 June 2009 (OJ
Parliament and of the Council on the Community code
L 168, 30.6.2009, p. 33),
relating to medicinal products for human use as regards
advanced therapy medicinal products ( 5 ) is to be incor
porated into the Agreement.
— 32009 L 0120: Commission Directive 2009/120/EC of
14 September 2009 (OJ L 242, 15.9.2009, p. 3).’.
(6) Directive 2009/35/EC repeals Council Directive
78/25/EEC ( 6 ) which is incorporated in the Agreement
and is therefore to be repealed under the Agreement,
Article 2

The texts of Regulation (EC) No 249/2009 and Directives
HAS ADOPTED THIS DECISION:
2009/35/EC, 2009/53/EC and 2009/120/EC in the Icelandic
and Norwegian languages, to be published in the EEA
Supplement to the Official Journal of the European Union, shall
Article 1
be authentic.
Chapter XIII of Annex II to the Agreement shall be amended as
follows:
Article 3
( 1 ) OJ L 143, 10.6.2010, p. 18.
This Decision shall enter into force on 2 July 2011, provided
( 2 ) OJ L 79, 25.3.2009, p. 34.
that all the notifications pursuant to Article 103(1) of the
( 3 ) OJ L 109, 30.4.2009, p. 10.
Agreement have been made to the EEA Joint Committee (*).
( 4 ) OJ L 168, 30.6.2009, p. 33.
( 5 ) OJ L 242, 15.9.2009, p. 3.
( 6 ) OJ L 11, 14.1.1978, p. 18. (*)
No
constitutional
requirements
indicated.

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EN
6.10.2011 Official
Journal
of
the
European
Union L
262/29
Article 4
This Decision shall be published in the EEA Section of, and in the EEA Supplement to, the Official Journal of
the European Union.
Done at Brussels, 1 July 2011.
For the EEA Joint Committee
The President
Kurt JGER

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