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Document 22020D0065
Decision of the EEA Joint Committee No 48/2018 of 23 March 2018 amending Annex II (Technical regulations, standards, testing and certification) to the EEA Agreement [2020/65]
Decision of the EEA Joint Committee No 48/2018 of 23 March 2018 amending Annex II (Technical regulations, standards, testing and certification) to the EEA Agreement [2020/65]
Decision of the EEA Joint Committee No 48/2018 of 23 March 2018 amending Annex II (Technical regulations, standards, testing and certification) to the EEA Agreement [2020/65]
OJ L 26, 30.1.2020, p. 26–27
(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
- Date of document:
- 23/03/2018; Date of adoption
- Date of effect:
- 01/12/2018; Entry into force See Art 3 And 22019D1003(01)
- Date of end of validity:
- No end date
- Author:
- EEA Joint Committee
- Form:
- Decision adopted by bodies created by international agreements
- Treaty:
- Agreement on the European Economic Area
- Legal basis:
-
- 21994A0103(01) - A98
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- Modifies:
-
Relation Act Comment Subdivision concerned From To Modifies 21994A0103(52) Addition chapter XIII point 15qe 01/12/2018 - Instruments cited:
- Link
- Related document(s):
-
- 22019D1003(01) Relation
- EUROVOC descriptor:
- Subject matter:
- Directory code:
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30.1.2020 |
EN |
Official Journal of the European Union |
L 26/26 |
DECISION OF THE EEA JOINT COMMITTEE
No 48/2018
of 23 March 2018
amending Annex II (Technical regulations, standards, testing and certification) to the EEA Agreement [2020/65]
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) |
Commission Directive (EU) 2017/1572 of 15 September 2017 supplementing Directive 2001/83/EC of the European Parliament and of the Council as regards the principles and guidelines of good manufacturing practice for medicinal products for human use (1) is to be incorporated into the EEA Agreement. |
|
(2) |
Annex II to the EEA Agreement should therefore be amended accordingly, |
HAS ADOPTED THIS DECISION:
Article 1
The following is inserted after point 15qd (Commission Delegated Regulation (EU) No 1252/2014) of Chapter XIII of Annex II to the EEA Agreement:
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‘15qe. |
32017 L 1572: Commission Directive (EU) 2017/1572 of 15 September 2017 supplementing Directive 2001/83/EC of the European Parliament and of the Council as regards the principles and guidelines of good manufacturing practice for medicinal products for human use (OJ L 238, 16.9.2017, p. 44). The provisions of the Directive shall, for the purposes of this Agreement, be read with the following adaptation:
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Article 2
The text of Directive (EU) 2017/1572 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 24 March 2018, 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, 23 March 2018.
For the EEA Joint Committee
The President
Claude MAERTEN
(1) OJ L 238, 16.9.2017, p. 44.
(*1) Constitutional requirements indicated.
