Commission Delegated Regulation (EU) 2018/92Show full title

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).

(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.

(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.

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

HAS ADOPTED THIS REGULATION:

(1)

OJ L 189, 27.6.2014, p. 112.

(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).

(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).