# L_2006289EN.01001201.xml

| 19.10.2006 | EN | Official Journal of the European Union | L 289/12 |
| --- | --- | --- | --- |

19.10.2006

EN

Official Journal of the European Union

L 289/12

---

DECISION OF THE EEA JOINT COMMITTEE

No 81/2006

of 7 July 2006

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 25/2006 of 10 March 2006 (1). |
| --- | --- |

(1)

Annex II to the Agreement was amended by Decision of the EEA Joint Committee No 25/2006 of 10 March 2006 (1).

| (2) | Commission Directive 2005/61/EC of 30 September 2005 implementing Directive 2002/98/EC of the European Parliament and of the Council as regards traceability requirements and notification of serious adverse reactions and events (2) is to be incorporated into the Agreement. |
| --- | --- |

(2)

Commission Directive 2005/61/EC of 30 September 2005 implementing Directive 2002/98/EC of the European Parliament and of the Council as regards traceability requirements and notification of serious adverse reactions and events (2) is to be incorporated into the Agreement.

| (3) | Commission Directive 2005/62/EC of 30 September 2005 implementing Directive 2002/98/EC of the European Parliament and of the Council as regards Community standards and specifications relating to a quality system for blood establishments (3) is to be incorporated into the Agreement, |
| --- | --- |

(3)

Commission Directive 2005/62/EC of 30 September 2005 implementing Directive 2002/98/EC of the European Parliament and of the Council as regards Community standards and specifications relating to a quality system for blood establishments (3) is to be incorporated into the Agreement,

HAS DECIDED AS FOLLOWS:

Article 1

The following points shall be inserted after point 15v (Commission Directive 2004/33/EC) of Chapter XIII of Annex II to the Agreement:

| ‘15va. | 32005 L 0061: Commission Directive 2005/61/EC of 30 September 2005 implementing Directive 2002/98/EC of the European Parliament and of the Council as regards traceability requirements and notification of serious adverse reactions and events (OJ L 256, 1.10.2005, p. 32). |
| --- | --- |

‘15va.

| 15vb. | 32005 L 0062: Commission Directive 2005/62/EC of 30 September 2005 implementing Directive 2002/98/EC of the European Parliament and of the Council as regards Community standards and specifications relating to a quality system for blood establishments (OJ L 256, 1.10.2005, p. 41).’ |
| --- | --- |

15vb.

Article 2

The texts of Directives 2005/61/EC and 2005/62/EC 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 8 July 2006, 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, 7 July 2006.

For the EEA Joint Committee

The President

Oda Helen SLETNES

---

(1)  
  OJ L 147, 1.6.2006, p. 37.

1

(2)  
  OJ L 256, 1.10.2005, p. 32.

2

(3)  
  OJ L 256, 1.10.2005, p. 41.

3

(*1)  Constitutional requirements indicated.

*1

---