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Document 22013D0158
Decision of the EEA Joint Committee No 158/2013 of 8 October 2013 amending Annex II (Technical regulations, standards, testing and certification) to the EEA Agreement
Decision of the EEA Joint Committee No 158/2013 of 8 October 2013 amending Annex II (Technical regulations, standards, testing and certification) to the EEA Agreement
Decision of the EEA Joint Committee No 158/2013 of 8 October 2013 amending Annex II (Technical regulations, standards, testing and certification) to the EEA Agreement
OJ L 58, 27.2.2014, p. 10–11
(BG, ES, CS, DA, DE, ET, EL, EN, FR, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)
In force
27.2.2014 |
EN |
Official Journal of the European Union |
L 58/10 |
DECISION OF THE EEA JOINT COMMITTEE
No 158/2013
of 8 October 2013
amending Annex II (Technical regulations, standards, testing and certification) to the EEA Agreement
THE EEA JOINT COMMITTEE,
Having regard to the Agreement on the European Economic Area (‘the EEA Agreement’), and in particular Article 98 thereof,
Whereas:
(1) |
Regulation (EU) No 1235/2010 of the European Parliament and of the Council of 15 December 2010 amending, as regards pharmacovigilance of medicinal products for human use, Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, and Regulation (EC) No 1394/2007 on advanced therapy medicinal products (1), as corrected by OJ L 201, 27.7.2012, p. 138, is to be incorporated into the EEA Agreement. |
(2) |
Directive 2010/84/EU of the European Parliament and of the Council of 15 December 2010 amending, as regards pharmacovigilance, Directive 2001/83/EC on the Community code relating to medicinal products for human use (2), as corrected by OJ L 21, 25.1.2011, p. 8 and OJ L 276, 21.10.2011, p. 63, is to be incorporated into the EEA Agreement. |
(3) |
Annex II to the EEA Agreement should therefore be amended accordingly, |
HAS ADOPTED THIS DECISION:
Article 1
Chapter XIII of Annex II to the EEA Agreement shall be amended as follows:
1. |
The following text is inserted after the words ‘Committee on Orphan Medicinal Products (COMP)’ in the 13th paragraph of the introductory text: ‘, the Pharmacovigilance Risk Assessment Committee (PRAC)’ |
2. |
Point 15q (Directive 2001/83/EC of the European Parliament and of the Council) shall be amended as follows:
|
3. |
The following indent is added in point 15zb (Regulation (EC) No 726/2004 of the European Parliament and of the Council):
|
4. |
The following is added in point 15zh (Regulation (EC) No 1394/2007 of the European Parliament and of the Council): ‘, as amended by:
|
Article 2
The texts of Regulation (EU) No 1235/2010, as corrected by OJ L 201, 27.7.2012, p. 138, and Directive 2010/84/EU, as corrected by OJ L 21, 25.1.2011, p. 8 and OJ L 276, 21.10.2011, p. 63, in the Icelandic and Norwegian languages, to be published in the EEA Supplement to the Official Journal of the European Union, shall be authentic.
Article 3
This Decision shall enter into force on 9 October 2013 or on the day following the last notification under Article 103(1) of the EEA Agreement, whichever is the later (3).
For Liechtenstein, this Decision shall enter into force on the same day or on the day of entry into force of the amendments to the Agreement between Liechtenstein and Austria laying down the technical details for Liechtenstein’s recognition of Austrian marketing authorisations within the decentralised procedure (DCP) and the mutual recognition procedure (MRP), whichever is the later.
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, 8 October 2013.
For the EEA Joint Committee
The President
Thórir IBSEN
(1) OJ L 348, 31.12.2010, p. 1.
(2) OJ L 348, 31.12.2010, p. 74.
(3) Constitutional requirements indicated.