Commissie verlaagt bureaucratische drempels voor MKB om nieuwe medicijnen te marketen en te verkopen (en)
New and innovative medicines can now be marketed easier to the benefit of patients. To encourage small and medium-sized enterprises (SMEs) to submit applications to the European Medicines Agency (EMEA), the European Commission has adopted significant fee reductions and deferrals for a number of EMEA services, such as scientific advice today.
Other provisions relate to administrative assistance, in particular regarding translations, and to the establishment of a dedicated SME Office within the EMEA, providing a `one-stop shop' for SMEs. 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. The regulation will enter into force in the coming days, following publication in the Official Journal.
Commission Vice President Günter Verheugen i stated: "SMEs contribute much to innovation in biotech and pharmaceutical sector. Fostering the competitiveness of those small but dynamic players is one concrete way to achieve our Growth and Jobs strategy, but also to support the development of new medicines."
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.
Additional information, including the Regulation itself, is available at: