Decision of the EEA Joint Committee No 10/2012 of 10 February 2012 amending Annex II (Technical regulations, standards, testing and certification) to the EEA Agreement
Date: 2012-02-10
Institutions: EEA Joint Committee
Subjects: European Economic Area, European Medicines Agency, alternative medicine, crop production, inflation, medical plant, medicinal product, revision of an agreement




L_2012161EN.01001601.xml










21.6.2012   


EN


Official Journal of the European Union


L 161/16








            DECISION OF THE EEA JOINT COMMITTEE
         
No 10/2012
of 10 February 2012
         
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, as amended by the Protocol adjusting the Agreement on the European Economic Area, hereinafter referred to as ‘the Agreement’, and in particular Article 98 thereof,

Whereas:







(1)


Annex II to the Agreement was amended by Decision of the EEA Joint Committee No 72/2011 of 1 July 2011 (1).












(2)


Commission Regulation (EU) No 301/2011 of 28 March 2011 amending Council Regulation (EC) No 297/95 as regards the adjustment of the fees of the European Medicines Agency to the inflation rate (2) is to be incorporated into the Agreement.












(3)


Commission Decision 2008/911/EC of 21 November 2008 establishing of a list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products (3) is to be incorporated into the Agreement.












(4)


Commission Decision 2010/28/EC of 28 July 2009 amending the list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products (4) is to be incorporated into the Agreement.












(5)


Commission Decision 2010/30/EU of 9 December 2009 amending the list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products (5) is to be incorporated into the Agreement.












(6)


Commission Decision 2010/180/EU of 25 March 2010 on amending Decision 2008/911/EC establishing a list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products (6) is to be incorporated into the Agreement,





HAS ADOPTED THIS DECISION:



Article 1
Chapter XIII of Annex II to the Agreement shall be amended as follows:






(1)


the following indent shall be added in point 15h (Council Regulation (EC) No 297/95):






‘—



32011 R 0301: Commission Regulation (EU) No 301/2011 of 28 March 2011 (OJ L 81, 29.3.2011, p. 5).’;














(2)


the following point shall be inserted after point 15zk (Commission Directive 2009/135/EC):






‘15zl.



32008 D 0911: Commission Decision 2008/911/EC of 21 November 2008 establishing of a list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products (OJ L 328, 6.12.2008, p. 42), as amended by:






—



32010 D 0028: Commission Decision 2010/28/EC of 28 July 2009 (OJ L 11, 16.1.2010, p. 12),










—



32010 D 0030: Commission Decision 2010/30/EU of 9 December 2009 (OJ L 12, 19.1.2010, p. 14),










—



32010 D 0180: Commission Decision 2010/180/EU of 25 March 2010 (OJ L 80, 26.3.2010, p. 52).’.














Article 2
The texts of Regulation (EU) No 301/2011 and Decisions 2008/911/EC, 2010/28/EC, 2010/30/EU and 2010/180/EU 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 11 February 2012, provided that all the notifications under Article 103(1) of the Agreement have been made to the EEA Joint Committee (*1).


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, 10 February 2012.


For the EEA Joint Committee


The Acting President

Gianluca GRIPPA
            





(1)  
            OJ L 262, 6.10.2011, p. 28.

(2)  
            OJ L 81, 29.3.2011, p. 5.

(3)  
            OJ L 328, 6.12.2008, p. 42.

(4)  
            OJ L 11, 16.1.2010, p. 12.

(5)  
            OJ L 12, 19.1.2010, p. 14.

(6)  
            OJ L 80, 26.3.2010, p. 52.

(*1)  No constitutional requirements indicated.