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European SME Status

On 25 April 2014 GRS was awarded SME status which means that GRS can take advantage of certain EU incentives.

 

So what’s it all about?

 

The European Medicines Agency (EMA) provides incentives for SMEs that are developing human or veterinary medicines for the purpose of promoting innovation and the development of new medicines.  The regulation behind these incentives is Commission Regulation (EC) No 2049/2005 which was adopted on 15 December 2005.

 

As long as a company is eligible for SME status they can take advantage of the following:

 

 

A substantial fee reduction (90%) is available to SMEs seeking Scientific Advice.  SMEs are encouraged to seek scientific advice from the agency early in the development process.  This helps the company to ensure that the appropriate studies are performed and maximises the chances of a successful marketing authorisation.

 

Below are some of the fee incentives available to SMEs:

 

ACTIVITY / APPLICATION FEE INCENTIVE
Scientific Advice

90% fee reduction for non-orphan products

100% fee reduction for designated orphan products

100% fee reduction for products granted eligibility to PRIority Medicines (PRIME)

Inspection (pre-authorisation)

90% fee reduction and deferral

100% fee reduction for designated orphan products
Application for Marketing Authorisation

Conditional fee exemption, where EMA scientific advice is followed and a marketing authorisation application is not successful

100% fee reduction for designated orphan products
Post-authorisation procedures (e.g. variations, extensions)

Fee exemption for micro-sized enterprises

40% fee reduction for small or medium-sized enterprises

100% fee reduction for designated orphan products during the first year after marketing authorisation (reverting to fee incentives according to size thereafter)
Scientific Services (e.g. certification, Article 58 procedures) 90% fee reduction for non-orphan products
100% fee reduction for designated orphan products
Establishment of maximum residue limits 90% fee reduction
Administrative Services (excluding parallel distribution) 100% fee reduction
Inspection (post-authorisation) 90% fee reduction
Pharmacovigilance

Fee exemption for micro-sized enterprises

40% fee reduction for small or medium-sized enterprises

 

 

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Please contact us to discuss your particular regulatory compliance requirements.

 

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