EMEA opens arms to small and medium sized biotech companies
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. The new services and reduced fees for SMEs are part of the implementing provisions in the new pharmaceutical legislation (Regulation (EC) No 726/2004) relating to SMEs. To implement this part of the Regulation, the EU Commission proposed a Fee Regulation that was adopted by the Council on November 14/15 2005 and the new SME Regulation, detailing SME specific provisions for companies developing medicinal products for human or veterinary use, which was adopted by the EU Commission on 15 December and is due to enter into force after publication in the Official Journal.
As part of the new deal, a special SME office will be installed at the EMEA. Its new head is Melanie Carr, previously with the Scientific Advice and Orphan Drugs Sector Pre-Authorisation Unit at the European Medicines Agency.
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