2003 discharge: European Agency for the Evaluation of Medicinal products

PURPOSE : presentation of the financial statements and the balance sheets for the European Agency for the Evaluation of Medicinal Products for the financial year 2003.

CONTENT : this report presented by the European Agency for the Evaluation of Medicinal Products presents the financial statements and balance sheets of its activities in 2003.

The appropriations entered in the final budget amount to EUR 84.2 million with a Community contribution of 23% (excluding subsidy for orphan medicines).

In terms of the staffing policy, the Agency, whose headquarters are in London (UK), officially provided 287 posts. 256 are occupied with + 48 other posts (auxiliary contracts, national experts on secondment, local and temporary staff). Therefore, there are a total of 304 assigned to operational and administrative duties.

In 2003, the Agency concentrated on the scientific evaluation of medicinal products.

As far as medicinal products for human use are concerned :

- Applications for marketing authorisations: 39;

- Favourable opinions: 39;

- Average evaluation time: 190 days;

- Opinions after authorisation: 941;

- Pharmacovigilance: 45 538 reports;

- Periodic reliability reports: 276;

- Monitoring measures: 1 025;

- Scientific opinions: 65;

- Procedures for mutual recognition: 4 080.

On the issue of Veterinary Medicinal Products:

- New applications: 10;

- Applications in respect of variants: 64;

- Inspection: 76.