Background

The European Medicines Agency has implemented Commission Regulation (EC) No 2049/2005 by providing incentives for micro, small and medium-sized enterprises (SMEs) that are developing medicines for human or veterinary use.

The Regulation describes implementing provisions relating to SMEs in the European Union pharmaceutical legislation and was adopted on 15 December 2005. It aims to promote innovation and the development of new medicines by SMEs.

The Agency's SME Office has the sole remit of offering assistance to SMEs. It aims to facilitate communication with SMEs through dedicated personnel within the Agency who respond to practical or procedural enquiries, monitor applications, and organise workshops and training sessions for SMEs.

• User guide for micro, small and medium-sized enterprises

Incentives

The incentives offered to SMEs apply to the human and veterinary sectors. They include:

• Administrative and procedural assistance from the SME Office;
• Fee reductions for scientific advice, scientific services, inspections and the establishment of maximum residue limits for veterinary medicines;
• Fee exemptions for certain administrative services of the Agency;
• Deferral of the fee payable for an application for marketing authorisation or related inspection;
• Conditional fee exemption where scientific advice is followed and a marketing authorisation application is not successful;
• Assistance with translations of the product information documents submitted in the application for marketing authorisation;
• Waiver of the MeDRA licensing fee when registring with EudraVigilance. This is only available for micro- or small enterprises and not for medium-sized enterprises;
• Inclusion in the public SME register.