# L_2017085EN.01003101.xml

| 30.3.2017 | EN | Official Journal of the European Union | L 85/31 |
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30.3.2017

EN

Official Journal of the European Union

L 85/31

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DECISION OF THE EEA JOINT COMMITTEE

No 213/2015

of 25 September 2015

amending Annex II (Technical regulations, standards, testing and certification) to the EEA Agreement [2017/520]

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 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (1) is to be incorporated into the EEA Agreement. |
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(1)

Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (1) is to be incorporated into the EEA Agreement.

| (2) | Regulation (EU) No 536/2014 repeals Directive 2001/20/EC of the European Parliament and of the Council (2), which is incorporated into the EEA Agreement, and which is consequently to be repealed under the EEA Agreement with effect from 6 months after the publication of the notice referred to in Article 82(3) of Regulation (EU) No 536/2014, but in any event no earlier than 28 May 2016. |
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(2)

Regulation (EU) No 536/2014 repeals Directive 2001/20/EC of the European Parliament and of the Council (2), which is incorporated into the EEA Agreement, and which is consequently to be repealed under the EEA Agreement with effect from 6 months after the publication of the notice referred to in Article 82(3) of Regulation (EU) No 536/2014, but in any event no earlier than 28 May 2016.

| (3) | Annex II to the EEA Agreement should therefore be amended accordingly, |
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(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 point is inserted after point 17 (Commission Directive (EU) 2015/566):






  ‘18. | 32014 R 0536: Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (OJ L 158, 27.5.2014, p. 1).’; |
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(1)

the following point is inserted after point 17 (Commission Directive (EU) 2015/566):

‘18.

| (2) | the text of point 15o (Directive 2001/20/EC of the European Parliament and of the Council) shall be deleted with effect from 6 months after the publication of the notice referred to in Article 82(3) of Regulation (EU) No 536/2014, but in any event no earlier than 28 May 2016. |
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(2)

the text of point 15o (Directive 2001/20/EC of the European Parliament and of the Council) shall be deleted with effect from 6 months after the publication of the notice referred to in Article 82(3) of Regulation (EU) No 536/2014, but in any event no earlier than 28 May 2016.

Article 2

The text of Regulation (EU) No 536/2014 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 26 September 2015, provided that all the notifications under Article 103(1) of the EEA Agreement have been made (*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, 25 September 2015.

For the EEA Joint Committee

The President

Ingrid SCHULERUD

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(1)  
  OJ L 158, 27.5.2014, p. 1.

1

(2)  
  OJ L 121, 1.5.2001, p. 34.

2

(*1)  Constitutional requirements indicated.

*1

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