Regulation 2005/2049 - Commission Regulation 2049/2005 laying down, pursuant to Regulation 726/2004, rules regarding the payment of fees to, and the receipt of administrative assistance from, the European Medicines Agency by micro, small and medium-sized enterprises - Main contents

EN

Official Journal of the European Union

L 329/4

Regulation (EC) No 726/2004, which replaces Council Regulation (EEC) No 2309/93 of 22 July 1993 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products (2), provides that the revenue of the European Medicines Agency (hereinafter referred to as the Agency) must consist of a contribution from the Community and fees paid by companies.

In the context of the system established by Regulation (EEC) No 2309/93, Council Regulation (EC) No 297/95 (3) provides for fees payable to the Agency.

Pursuant to Regulation (EC) No 726/2004, the situation of micro, small and medium-sized enterprises (SMEs) has to be considered separately. In order to reduce the cost for SMEs of marketing medicinal products authorised via the centralised procedure, that Regulation therefore foresees the adoption of specific provisions allowing a reduction of fees, deferring the payment of fees, and providing administrative assistance. Such provisions should apply equally to the human and veterinary sectors and should aim at promoting innovation and the development of new medicinal products by SMEs.

The definition of micro, small and medium-sized enterprises provided in Commission Recommendation 2003/361/EC (4) should apply, for reasons of coherence and transparency.

Experience gained since the adoption of Regulation (EEC) No 2309/93 shows that the main financial and administrative entry hurdles for SMEs are the various steps involved in pre-marketing authorisation procedures, such as the seeking of scientific advice, the submission of the marketing authorisation application, and the undergoing of inspections. Provisions laid down in this Regulation should therefore be focused on these aspects.

The fees for the marketing authorisation application and the related inspections conducted for the purpose of assessing the application could constitute a significant financial constraint for SMEs. Consequently, in order to avoid a weakening of the financial situation of undertakings during the assessment of the marketing authorisation application, it is appropriate to defer the payment of these fees until the end of the procedure.

SMEs operating in the pharmaceutical sector are often innovative companies, such as those active in the fields of gene or somatic cell therapy, which can notably benefit from the pooling of scientific expertise at a Community level. Furthermore, the scientific evaluation of a marketing authorisation application is more likely to be favourable in the case of medicinal products which have obtained scientific advice. Therefore, access to the Agency’s scientific advice for SMEs seeking marketing authorisation should be facilitated through fee reductions. As an additional incentive, a conditional fee exemption should be given to applicants who have...