European Medicines Agency organises SME workshop dedicated to veterinary topics

9 October 2013

The European Medicines Agency (EMA) is holding a workshop for micro, small and medium-sized enterprises (SMEs) on 7 November 2013. For the first time, the workshop will be dedicated specifically to SMEs developing veterinary medicines.

The aim of the workshop is to provide practical information for SMEs working in the veterinary-medicines field, including:

• early support during medicines development, such as minor-use-minor-species (MUMS) designation and the scientific-advice procedure;
• regulatory aspects in the run-up to dossier submission, including marketing-authorisation application, inspections and maximum residue limits (MRLs) for active substances and excipients.

Expressions of interest in participating in the workshop should be sent to [e-mail] by 18 October 2013, using the registration form provided.

The workshop is open to companies that have been assigned SME status by the EMA and to representatives of stakeholder organisations. Other participants will also be welcome, space permitting.

The Agency launched its SME initiative in December 2005 to promote innovation and development of medicines by SMEs, recognising that SMEs are a major driver of innovation in the pharmaceutical industry. This initiative provides regulatory, financial and administrative support to these companies in the development and authorisation of their medicines.

The support takes the form of individual guidance and more general advice through the SME user guide, topical workshops and a dedicated newsletter, as well as fee incentives and assistance with translations of the product information required for the granting of a European Union marketing authorisation. More than 1,200 SME companies are now registered with the Agency.