2006 discharge: European Medicines Agency EMEA

PURPOSE: presentation of the final accounts of the European Medicines Agency for the financial year 2006.

CONTENT: this document sets out a detailed account of the implementation of the 2006 budget, including the revenue and expenditure and the balance sheet for the year concerned.

According to this document, the final budget amounted to EUR 138.7 million (in comparison to EUR 111.8 million in 2005) consisting of a 21.63% Community contribution (excluding subsidy for orphan medicines).

As regards staffing, the Agency, whose head office is based in London (UK), set out a total of 424 posts in the establishment plan. 395 posts are currently occupied + 77 other posts (auxiliary contracts, seconded national experts and employment agency staff) totalling 472 posts assigned to operational and administrative tasks. Staff expenditure in 2006 accounted for EUR 42.941 million (final appropriations paid).

Throughout 2006, the Agency concentrated on coordinating the scientific evaluation of medicinal products.

Concerning medicinal products for human use, the Agency:

• replied to 79 applications for marketing authorisations and delivered 51 favourable opinions taking an average evaluation time of 171 days;
• delivered 1 380 opinions after authorisation;
• drafted 94 081 pharmacovigilance reports (64 186 in 2004) and 273 periodic reliability reports;
• delivered 193 scientific opinions and 9 241 procedures for mutual recognition.

Concerning veterinary medicinal products, the Agency:

• replied to 5 new applications for marketing authorisations and 56 applications in respect of variants;
• carried out 128 inspections.

As regards orphan medicinal products, the Agency replied to 104 applications and gave 81 favourable opinions.

The complete version of the final accounts may be found at the following address: http://www.emea.europa.eu/index/indexg1.htm.