2004 discharge: European Agency for the Evaluation of Medicinal Products

PURPOSE : presentation of the final accounts of the European Medicines Agency for the financial year 2004.

CONTENT : this document published in the Official Journal of the EU sets out a detailed account of the implementation of the 2004 budget, including the revenue and expenditure and the balance sheet for the year concerned.

According to this document, the final budget amounted to EUR 99,1 million (in comparison to EUR 84,2 million in 2003) consisting of a 27% Community contribution (excluding subsidy for orphan medicines). 

As regards staffing, the Agency, whose headquarters are based in London (UK), set out a total of 314 posts in the establishment plan. 290 posts are currently occupied + 50 other posts (auxiliary contracts, seconded national experts, local staff, employment agency staff) totalling 340 posts (304 in 2003) assigned to operational, administrative and mixed tasks.

Staff expenditure accounted for EUR 34,333 000.

Throughout 2004, the Agency concentrated on coordinating the scientific evaluation of medicinal products which are subject to Community marketing authorisation procedures.

Concerning medicinal products for human use, the Agency:

- replied to 51 applications for marketing authorisations and delivered 34 favourable opinions taking an average evaluation time of 187 days as opposed to 190 days in 2003;

- delivered 926 opinions after authorisation: 926;

- drafted 64 186 pharmacovigilance reports and 253 periodic reliability reports;

- delivered 948 monitoring measures, 77 scientific opinions and 7 081 procedures for mutual recognition.

Concerning veterinary medicinal products, the Agency:

- replied to 8 new applications for marketing authorisations and 40 applications in respect of variants;

- carried out 93 inspections.

Yearly operating expenditure represented EUR 38 573 000. A positive operating result was achieved at EUR 8 353 000 as well as a positive economic outturn of EUR 9 513 000.

The complete version of the final accounts may be found at the following address:

www.emea.eu.int