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In order to encourage Small and Medium-sized Enterprises (SMEs) to submit applications to the European Medicines Agency (EMEA) (1) , the European Commission has adopted significant fee reductions and deferrals (2) for a number of EMEA services, such as scientific advice.

This new SME Regulation, detailing SME specific provisions for companies developing medicinal products for human or veterinary use, has been adopted by the European Commission on 15 December 2005 and is due to enter into force after publication in the Official Journal (3).  

The new EMEA benefits for SMEs include reduction of fees, deferral of payment of fees, taking over the responsibility for translations and offering administrative assistance in respect of these enterprises.   As support to these new provisions, a special SME office will be installed at the EMEA, providing a ‘one-stop shop’ for SMEs (4).

These measures respond to the need to pay special attention to small businesses, which often lack regulatory resources and financial stability to cope with the EU pharmaceutical legislation.

Key measures of the new Commission Regulation include:

- 90% reduction on a number of fees payable to the EMEA, such as: scientific advice, inspections, and other scientific services;
- Exemption of the fee for administrative services;
- Exemption of the fee for scientific advice in respect of orphan medicines;
- Deferral of the fee for the marketing authorisation application until the end of  the evaluation procedure;
- Conditional fee exemptions where scientific advice has been sought and effectively implemented;
- A system for outsourcing translations of the documents required for the granting of the marketing authorisation;
- The establishment of an SME Office, within the EMEA, to offer administrative assistance, facilitate communication and answer enquiries;
- A user guide on the administrative and procedural aspects of the Community marketing authorisation procedure, which are of particular relevance for SMEs.

To qualify, SMEs must meet the EU definition of an SME (5) and send an email request to the EMEA.  A company’s status as an SME will be reviewed annually.  There are concerns that the EU definition of SME status may be too narrowly defined to cover all biotech companies, but there is scope to consider SME status qualification case by case.  

Further Information:

Additional information, including the Regulation itself, is available at:
http://pharmacos.eudra.org/F2/home.html

(1)   EMEA web site

http://www.emea.europa.eu

(2)   Fees Regulation

http://pharmacos.eudra.org/F2/pharmacos/docs/Doc2005/11_05/Reg_2005_1905_EN.pdf

(3)   SME Regulation http://pharmacos.eudra.org/F2/pharmacos/new.htm

(4)   Address
Melanie Carr,
European Medicines Agency (EMEA)
7 Westferry Circus, Canary Wharf London E14 4HB -
United Kingdom
Tel: (44 20) 74 18 8575
Fax: (44 20) 75 23 7040
E-mail: Liina.Buckingham@emea.europa.eu
http://www.emea.europa.eu

(5)   SME definition To determine which companies are eligible for SME incentives, EMEA will apply the definition of micro, small and medium-sized enterprises provided in Commission Recommendation 2003/361/EC

http://europa.eu.int/eur-lex/pri/en/oj/dat/2003/l_124/l_12420030520en00360041.pdf

Further information on the definition of an SME is available in the "User
Guide and model Declaration for the New SME definition" which has been
Published by the European Commission

http://europa.eu.int/comm/enterprise/enterprise_policy/sme_definition/index_en.htm