# L_2018017EN.01000201.xml

| 23.1.2018 | EN | Official Journal of the European Union | L 17/2 |
| --- | --- | --- | --- |

23.1.2018

EN

Official Journal of the European Union

L 17/2

---

COMMISSION DELEGATED REGULATION (EU) 2018/92

of 18 October 2017

amending Regulation (EU) No 658/2014 of the European Parliament and of the Council as regards the adjustment to the inflation rate of the amounts of the fees payable to the European Medicines Agency for the conduct of pharmacovigilance activities in respect of medicinal products for human use

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EU) No 658/2014 of the European Parliament and of the Council of 15 May 2014 on fees payable to the European Medicines Agency for the conduct of pharmacovigilance activities in respect of medicinal products for human use (1), and in particular Article 15(6) 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 consists of a contribution from the Union and fees paid by undertakings for obtaining and maintaining Union marketing authorisations and for other services provided by the Agency, or by the coordination group as regards the fulfilment of its tasks in accordance with Articles 107c, 107e, 107g, 107k and 107q of Directive 2001/83/EC of the European Parliament and of the Council (3). |
| --- | --- |

(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 consists of a contribution from the Union and fees paid by undertakings for obtaining and maintaining Union marketing authorisations and for other services provided by the Agency, or by the coordination group as regards the fulfilment of its tasks in accordance with Articles 107c, 107e, 107g, 107k and 107q of Directive 2001/83/EC of the European Parliament and of the Council (3).

| (2) | The inflation rate of the Union, as published by the Statistical Office of the European Union, was 0,2 % for 2015 and 1,2 % for 2016. Taking into consideration the very low inflation rate in 2015, it was not considered justified to adjust, in accordance with Article 15(6) of Regulation (EU) No 658/2014, the amounts of the fees payable to the European Medicines Agency for the conduct of pharmacovigilance activities in respect of medicinal products for human use. In view of the inflation rate of the Union for 2016, it is considered justified to adjust those amounts. A cumulative adjustment taking into account the inflation rates for 2015 and for 2016 should be applied. |
| --- | --- |

(2)

The inflation rate of the Union, as published by the Statistical Office of the European Union, was 0,2 % for 2015 and 1,2 % for 2016. Taking into consideration the very low inflation rate in 2015, it was not considered justified to adjust, in accordance with Article 15(6) of Regulation (EU) No 658/2014, the amounts of the fees payable to the European Medicines Agency for the conduct of pharmacovigilance activities in respect of medicinal products for human use. In view of the inflation rate of the Union for 2016, it is considered justified to adjust those amounts. A cumulative adjustment taking into account the inflation rates for 2015 and for 2016 should be applied.

| (3) | For the sake of simplicity, the adjusted amounts should be rounded to the nearest EUR 10, with the exception of the annual fee for information technology systems and literature monitoring where the adjusted level should be rounded to the nearest EUR 1. |
| --- | --- |

(3)

For the sake of simplicity, the adjusted amounts should be rounded to the nearest EUR 10, with the exception of the annual fee for information technology systems and literature monitoring where the adjusted level should be rounded to the nearest EUR 1.

| (4) | Fees laid down in Regulation (EU) No 658/2014 are due either at the date of the start of the respective procedure or, in the case of the annual fee for information technology systems and literature monitoring, on 1 July of every year. Consequently, the applicable amount will be determined by the due date of the fee and there is no need to set specific transitional provisions for pending procedures. |
| --- | --- |

(4)

Fees laid down in Regulation (EU) No 658/2014 are due either at the date of the start of the respective procedure or, in the case of the annual fee for information technology systems and literature monitoring, on 1 July of every year. Consequently, the applicable amount will be determined by the due date of the fee and there is no need to set specific transitional provisions for pending procedures.

| (5) | According to Article 15(6) of Regulation (EU) No 658/2014, where a delegated act adjusting the amounts of the fees laid down in Parts I to IV of the Annex to that Regulation enters into force before 1 July, the adjustments are to take effect as from 1 July, whereas where it enters into force after 30 June, the adjustments are to take effect from the date of entry into force of the delegated act. |
| --- | --- |

(5)

According to Article 15(6) of Regulation (EU) No 658/2014, where a delegated act adjusting the amounts of the fees laid down in Parts I to IV of the Annex to that Regulation enters into force before 1 July, the adjustments are to take effect as from 1 July, whereas where it enters into force after 30 June, the adjustments are to take effect from the date of entry into force of the delegated act.

| (6) | The Annex to Regulation (EU) No 658/2014 should therefore be amended accordingly, |
| --- | --- |

(6)

The Annex to Regulation (EU) No 658/2014 should therefore be amended accordingly,

HAS ADOPTED THIS REGULATION:

Article 1

The Annex to Regulation (EU) No 658/2014 is amended as follows:

| (1) | in Part I, point 1 is amended as follows:






  (a) | ‘EUR 19 500’ is replaced by ‘EUR 19 770’; |
| --- | --- | --- |

(1)

in Part I, point 1 is amended as follows:

(a)

‘EUR 19 500’ is replaced by ‘EUR 19 770’;

| (b) | ‘EUR 13 100’ is replaced by ‘13 290’; |
| --- | --- |

(b)

‘EUR 13 100’ is replaced by ‘13 290’;

| (2) | in Part II, point 1 is amended as follows:






  (a) | in the introductory sentence, ‘EUR 43 000’ is replaced by ‘EUR 43 600’; |
| --- | --- | --- |

(2)

in Part II, point 1 is amended as follows:

(a)

in the introductory sentence, ‘EUR 43 000’ is replaced by ‘EUR 43 600’;

| (b) | point (a) is amended as follows:






  (i) | ‘EUR 17 200’ is replaced by ‘EUR 17 440’; |
| --- | --- | --- |

(b)

point (a) is amended as follows:

(i)

‘EUR 17 200’ is replaced by ‘EUR 17 440’;

| (ii) | ‘EUR 7 280’ is replaced by ‘EUR 7 380’; |
| --- | --- |

(ii)

‘EUR 7 280’ is replaced by ‘EUR 7 380’;

| (c) | point (b) is amended as follows:






  (i) | ‘EUR 25 800’ is replaced by ‘EUR 26 160’; |
| --- | --- | --- |

(c)

point (b) is amended as follows:

(i)

‘EUR 25 800’ is replaced by ‘EUR 26 160’;

| (ii) | ‘EUR 10 920’ is replaced by ‘11 070’; |
| --- | --- |

(ii)

‘EUR 10 920’ is replaced by ‘11 070’;

| (3) | in Part III, point 1 is amended as follows:






  (a) | the first subparagraph is amended as follows:






  (i) | ‘EUR 179 000’ is replaced by ‘EUR 181 510’; |
| --- | --- | --- | --- |

(3)

in Part III, point 1 is amended as follows:

(a)

the first subparagraph is amended as follows:

(i)

‘EUR 179 000’ is replaced by ‘EUR 181 510’;

| (ii) | ‘EUR 38 800’ is replaced by ‘EUR 39 350’; |
| --- | --- |

(ii)

‘EUR 38 800’ is replaced by ‘EUR 39 350’;

| (iii) | ‘EUR 295 400’ is replaced by ‘EUR 299 560’; |
| --- | --- |

(iii)

‘EUR 295 400’ is replaced by ‘EUR 299 560’;

| (b) | the second subparagraph is amended as follows:






  (i) | in point (a), ‘EUR 119 333’ is replaced by ‘EUR 121 000’; |
| --- | --- | --- |

(b)

the second subparagraph is amended as follows:

(i)

in point (a), ‘EUR 119 333’ is replaced by ‘EUR 121 000’;

| (ii) | in point (b), ‘EUR 145 200’ is replaced by ‘EUR 147 240’; |
| --- | --- |

(ii)

in point (b), ‘EUR 145 200’ is replaced by ‘EUR 147 240’;

| (iii) | in point (c), ‘EUR 171 066’ is replaced by ‘EUR 173 470’; |
| --- | --- |

(iii)

in point (c), ‘EUR 171 066’ is replaced by ‘EUR 173 470’;

| (iv) | in point (d), ‘EUR 196 933’ is replaced by ‘EUR 199 700’; |
| --- | --- |

(iv)

in point (d), ‘EUR 196 933’ is replaced by ‘EUR 199 700’;

| (c) | in the fourth subparagraph, point (b) is amended as follows:






  (i) | ‘EUR 1 000’ is replaced by ‘EUR 1 010’; |
| --- | --- | --- |

(c)

in the fourth subparagraph, point (b) is amended as follows:

(i)

‘EUR 1 000’ is replaced by ‘EUR 1 010’;

| (ii) | ‘EUR 2 000’ is replaced by ‘EUR 2 020’; |
| --- | --- |

(ii)

‘EUR 2 000’ is replaced by ‘EUR 2 020’;

| (iii) | ‘EUR 3 000’ is replaced by ‘EUR 3 050’; |
| --- | --- |

(iii)

‘EUR 3 000’ is replaced by ‘EUR 3 050’;

| (4) | in point 1 of Part IV, ‘EUR 67’ is replaced by ‘EUR 68’. |
| --- | --- |

(4)

in point 1 of Part IV, ‘EUR 67’ is replaced by ‘EUR 68’.

Article 2

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. It shall apply from 12 February 2018.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 18 October 2017.

For the Commission

The President

Jean-Claude JUNCKER

---

(1)  
  OJ L 189, 27.6.2014, p. 112.

1

(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).

2

(3)  Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ L 311, 28.11.2001, p. 67).

3

---