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:
- regulatory and administrative assistance
- workshops and training sessions
- fee incentives
- assistance with translations of the product information required for the granting of an EU marketing authorisation
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 |
