Micro, Small and Medium Sized Enterprises (SMEs)
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Are you recognised as an SME?
Micro, small and medium-sized enterprises (SMEs) have been described as the engine of the European economy. They create entrepreneurial spirit and innovation in the EU. For small innovative companies the EMEA offers incentives to assist their development programmes. The headcount of your company is one of the critical criteria defining SME status (also ownership/partnership, turnover etc), as micro (fewer than 10 people), small (fewer than 50 people) and medium (fewer than 250 people) enterprises.
There is a dedicated group set up by EMEA for SMEs operating in the pharmaceutical sector. Its aim is to facilitate understanding of the main aspects of medicinal product legislation.
Background
The legislative basis is in Regulation 726/2004 which introduced a provision for financial and administrative assistance for SMEs, implementing Regulation (EC) No 2049/2005.
Advantages
EMEA will provide administrative and procedural assistance to SMEs. There are fee reductions available for scientific advice, inspections and (for veterinary medicines) establishment of maximum residue limits. In addition there are further fee exemptions for certain administrative services of the EMEA. Deferral of the fee payable for an application for marketing authorisation or related inspection is possible. There is a conditional fee exemption, where scientific advice is followed and a marketing authorisation application is not successful. EMEA will also provide assistance with translations of the product information documents submitted with your application for marketing authorisation.
How to apply
Akos can assist in the preparation of a declaration form and appropriate supporting documents.
To discuss your regulatory questions with Akos please contact us:
Tel: +44 (0)1582 766 339
Email: regulatory@akos.co.uk