2005 discharge: European Agency for the Evaluation of Medicinal Products
PURPOSE: presentation of the final accounts of the European Medicines Agency for the financial year 2005.
CONTENT: this document published in the Official Journal of the EU sets out a detailed account of the implementation of the 2005 budget, including the revenue and expenditure and the balance sheet for the year concerned.
According to this document, the final budget amounted to EUR 111.8 million (in comparison to EUR 99.4 million in 2004) consisting of a 22.7% Community contribution.
As regards staffing, the Agency, whose headquarters are based in London (UK), set out a total of 379 posts in the establishment plan. 337.5 posts are currently occupied + 34 other posts (auxiliary contracts, seconded national experts, local staff, employment agency staff) totalling 317.5 posts (340 in 2004) assigned to operational, administrative and mixed tasks.
Staff expenditure accounted for EUR 41.356 million.
Throughout 2005, 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 43 applications for marketing authorisations and delivered 24 favourable opinions taking an average evaluation time of 203 days as opposed to 187 days in 2004;
- delivered 1 148 opinions after authorisation;
- drafted 91 565 pharmacovigilance reports (64 186 in 2004) and 279 periodic reliability reports;
- delivered 135 scientific opinions and 8 451 procedures for mutual recognition.
Concerning veterinary medicinal products, the Agency:
- replied to 11 new applications for marketing authorisations and 70 applications in respect of variants;
- carried out 114 inspections.
As regards orphan medicinal products, the Agency:
- replied to 118 applications and gave 88 favourable opinions.
The complete version of the final accounts may be found at the following address: