委员会条例(EU) No 272/2014，就因通胀率而调整欧洲药品管理局费用方面，修订理事会条例(EC) No 297/95
技术法规类型：欧盟Eurlex法规 来源：tbtmap
EURLEX ID：32014R0272
OJ编号：OJ L 79, 18.3.2014, p. 37-39
中文标题：委员会条例(EU) No 272/2014，就因通胀率而调整欧洲药品管理局费用方面，修订理事会条例(EC) No 297/95
原文标题：Commission Regulation (EU) No 272/2014 of 17 March 2014 amending Council Regulation (EC) No 297/95 as regards the adjustment of the fees of the European Medicines Agency to the inflation rate Text with EEA relevance
amending Council Regulation (EC) No 297/95 as regards the adjustment of the fees of the European Medicines Agency to the inflation rate
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Council Regulation (EC) No 297/95 of 10 February 1995 on fees payable to the European Agency for the Evaluation of Medicinal Products (1), and in particular the fifth paragraph of Article 12 thereof,
Whereas:
(1)
In accordance with Article 67(3) of Regulation (EC) No 726/2004 of the European Parliament and of the Council (2), the revenue of the European Medicines Agency (hereinafter ‘the Agency‘� consists of a contribution from the Union and fees paid by undertakings to the Agency. Regulation (EC) No 297/95 lays down the categories and levels of such fees.
(2)
Those fees should be updated by reference to the inflation rate of 2013. The inflation rate in the Union, as published by the Statistical Office of the European Union (Eurostat), was 1,5 % in 2013.
(3)
For the sake of simplicity, the adjusted levels of the fees should be rounded to the nearest EUR 100.
(4)
Regulation (EC) No 297/95 should therefore be amended accordingly.
(5)
For reasons of legal certainty, this Regulation should not apply to valid applications which are pending on 1 April 2014.
(6)
In accordance with Article 12 of Regulation (EC) No 297/95, the update is to be made with effect from 1 April 2014. It is therefore appropriate that this Regulation enters into force as a matter of urgency and applies from that date,
HAS ADOPTED THIS REGULATION:
Article 1
Regulation (EC) No 297/95 is amended as follows:
(1)
Article 3 is amended as follows:
(a)
paragraph 1 is amended as follows:
(i)
point (a) is amended as follows:
‘�/p>
in the first subparagraph, ‘楨UR 274 400‘�is replaced by ‘楨UR 278 500‘�
‘�/p>
in the second subparagraph, ‘楨UR 27 500‘�is replaced by ‘楨UR 27 900‘�
‘�/p>
in the third subparagraph, ‘楨UR 6 900‘�is replaced by ‘楨UR 7 000‘�
(ii)
point (b) is amended as follows:
‘�/p>
in the first subparagraph, ‘楨UR 106 500‘�is replaced by ‘楨UR 108 100‘�
‘�/p>
in the second subparagraph, ‘楨UR 177 300‘�is replaced by ‘楨UR 180 000‘�
‘�/p>
in the third subparagraph, ‘楨UR 10 600‘�is replaced by ‘楨UR 10 800‘�
‘�/p>
in the fourth subparagraph, ‘楨UR 6 900‘�is replaced by ‘楨UR 7 000‘�
(iii)
point (c) is amended as follows:
‘�/p>
in the first subparagraph, ‘楨UR 82 400‘�is replaced by ‘楨UR 83 600‘�
‘�/p>
in the second subparagraph, ‘楨UR 20 600 to EUR 61 800‘�is replaced by ‘楨UR 20 900 to EUR 62 700‘�
‘�/p>
in the third subparagraph, ‘楨UR 6 900‘�is replaced by ‘楨UR 7 000‘�
(b)
paragraph 2 is amended as follows:
(i)
the first subparagraph of point (a) is amended as follows:
‘�/p>
‘楨UR 6 900‘�is replaced by ‘楨UR 7 000‘�
(ii)
point (b) is amended as follows:
‘�/p>
in the first subparagraph, ‘楨UR 82 400‘�is replaced by ‘楨UR 83 600‘�
‘�/p>
in the second subparagraph, ‘楨UR 20 600 to EUR 61 800‘�is replaced by ‘楨UR 20 900 to EUR 62 700‘�
(c)
in paragraph 3, ‘楨UR 13 600‘�is replaced by ‘楨UR 13 800‘�
(d)
in paragraph 4, ‘楨UR 20 600‘�is replaced by ‘楨UR 20 900‘�
(e)
in paragraph 5, ‘楨UR 6 900‘�is replaced by ‘楨UR 7 000‘�
(f)
paragraph 6 is amended as follows:
(i)
in the first subparagraph, ‘楨UR 98 400‘�is replaced by ‘楨UR 99 900‘�
(ii)
in the second subparagraph, ‘楨UR 24 500 to EUR 73 800‘�is replaced by ‘楨UR 24 900 to EUR 74 900‘�
(2)
in Article 4, ‘楨UR 68 400‘�is replaced by ‘楨UR 69 400‘�
(3)
article 5 is amended as follows:
(a)
paragraph 1 is amended as follows:
(i)
point (a) is amended as follows:
‘�/p>
in the first subparagraph, ‘楨UR 137 300‘�is replaced by ‘楨UR 139 400‘�
‘�/p>
in the second subparagraph, ‘楨UR 13 600‘�is replaced by ‘楨UR 13 800‘�
‘�/p>
in the third subparagraph, ‘楨UR 6 900‘�is replaced by ‘楨UR 7 000‘�
‘�/p>
the fourth subparagraph is amended as follows:
‘�/p>
‘楨UR 68 400‘�is replaced by ‘楨UR 69 400‘�
‘�/p>
‘楨UR 6 900‘�is replaced by ‘楨UR 7 000‘�
(ii)
point (b) is amended as follows:
‘�/p>
in the first subparagraph, ‘楨UR 68 400‘�is replaced by ‘楨UR 69 400‘�
‘�/p>
in the second subparagraph, ‘楨UR 116 000‘�is replaced by ‘楨UR 117 700‘�
‘�/p>
in the third subparagraph, ‘楨UR 13 600‘�is replaced by ‘楨UR 13 800‘�
‘�/p>
in the fourth subparagraph, ‘楨UR 6 900‘�is replaced by ‘楨UR 7 000‘�
‘�/p>
the fifth subparagraph is amended as follows:
‘�/p>
‘楨UR 34 300‘�is replaced by ‘楨UR 34 800‘�
‘�/p>
‘楨UR 6 900‘�is replaced by ‘楨UR 7 000‘�
(iii)
point (c) is amended as follows:
‘�/p>
in the first subparagraph, ‘楨UR 34 300‘�is replaced by ‘楨UR 34 800‘�
‘�/p>
in the second subparagraph, ‘楨UR 8 600 to EUR 25 700‘�is replaced by ‘楨UR 8 700 to EUR 26 100‘�
‘�/p>
in the third subparagraph, ‘楨UR 6 900‘�is replaced by ‘楨UR 7 000‘�
(b)
paragraph 2 is amended as follows:
(i)
point (a) is amended as follows:
‘�/p>
‘楨UR 6 900‘�is replaced by ‘楨UR 7 000‘�
(ii)
point (b) is amended as follows:
‘�/p>
in the first subparagraph, ‘楨UR 41 100‘�is replaced by ‘楨UR 41 700‘�
‘�/p>
in the second subparagraph, ‘楨UR 10 300 to EUR 30 900‘�is replaced by ‘楨UR 10 500 to EUR 31 400‘�
‘�/p>
in the third subparagraph, ‘楨UR 6 900‘�is replaced by ‘楨UR 7 000‘�
(c)
in paragraph 3, ‘楨UR 6 900‘�is replaced by ‘楨UR 7 000‘�
(d)
in paragraph 4, ‘楨UR 20 600‘�is replaced by ‘楨UR 20 900‘�
(e)
in paragraph 5, ‘楨UR 6 900‘�is replaced by ‘楨UR 7 000‘�
(f)
paragraph 6 is amended as follows:
(i)
in the first subparagraph, ‘楨UR 32 800‘�is replaced by ‘楨UR 33 300‘�
(ii)
in the second subparagraph, ‘楨UR 8 200 to EUR 24 500‘�is replaced by ‘楨UR 8 300 to EUR 24 900‘�
(4)
in Article 6, ‘楨UR 41 100‘�is replaced by ‘楨UR 41 700‘�
(5)
Article 7 is amended as follows:
(a)
in the first paragraph, ‘楨UR 68 400‘�is replaced by ‘楨UR 69 400‘�
(b)
in the second paragraph, ‘楨UR 20 600‘�is replaced by ‘楨UR 20 900‘�
(6)
Article 8 is amended as follows:
(a)
paragraph 1 is amended as follows:
(i)
in the second subparagraph, ‘楨UR 82 400‘�is replaced by ‘楨UR 83 600‘�
(ii)
in the third subparagraph, ‘楨UR 41 100‘�is replaced by ‘楨UR 41 700‘�
(iii)
in the fourth subparagraph, ‘楨UR 20 600 to EUR 61 800‘�is replaced by ‘楨UR 20 900 to EUR 62 700‘�
(iv)
in the fifth subparagraph, ‘楨UR 10 300 to EUR 30 900‘�is replaced by ‘楨UR 10 500 to EUR 31 400‘�
(b)
paragraph 2 is amended as follows:
(i)
in the second subparagraph, ‘楨UR 274 400‘�is replaced by ‘楨UR 278 500‘�
(ii)
in the third subparagraph, ‘楨UR 137 300‘�is replaced by ‘楨UR 139 400‘�
(iii)
in the fifth subparagraph, ‘楨UR 3 000 to EUR 236 500‘�is replaced by ‘楨UR 3 000 to EUR 240 000‘�
(iv)
in the sixth subparagraph, ‘楨UR 3 000 to EUR 118 400‘�is replaced by ‘楨UR 3 000 to EUR 120 200‘�
(c)
in paragraph 3, ‘楨UR 6 900‘�is replaced by ‘楨UR 7 000‘�
Article 2
This Regulation shall not apply to valid applications pending on 1 April 2014.
Article 3
This Regulation shall enter into force on the day following that of its publication in the Official Journal of the European Union.
It shall apply from 1 April 2014.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
(2) Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ L 136, 30.4.2004, p. 1).
