Supporting your regulatory activities via Boyds’ SME status
Boyds has registered SME status to support micro, small and medium sized enterprises operating in the pharmaceutical sector, seeking regulatory support and marketing authorization of medicinal products in the European Union (EU).
SME status is available through Boyds for eligible non-EU SMEs, and will lead to significant savings and incentives, promoting the ability to develop and authorize new medicines for the European market.
In December 2005, Commission Regulation (EC) No 2049/2005 (‘SME Regulation’) introduced provisions aimed at promoting innovation and the development of new medicinal products by SMEs.
To help achieve this, incentives have been put in place to help SMEs overcome the administrative and financial barriers associated with pre-marketing procedures, in particular scientific advice, marketing authorization application and inspection procedures. Further incentives are also available for post-authorization procedures.
How Boyds can help you to obtain SME status in the EU
SME status is available through Boyds for eligible non-EU SMEs, and will lead to significant savings and incentives, promoting the ability to develop and authorize new medicines for the European market.
In December 2005, Commission Regulation (EC) No 2049/2005 (‘SME Regulation’) introduced provisions aimed at promoting innovation and the development of new medicinal products by SMEs.
To help achieve this, incentives have been put in place to help SMEs overcome the administrative and financial barriers associated with pre-marketing procedures, in particular scientific advice, marketing authorization application and inspection procedures. Further incentives are also available for post-authorization procedures.
Incentives for SMEs
SMEs in the pharmaceutical sector are typically innovative companies that can benefit from access to scientific expertise at EU level. The SME initiative offers a substantial 90% fee reduction for scientific advice, helping to encourage SMEs to seek advice and support from EMA on all issues relating to the development of new medicinal products, helping to maximise the chances of success with their marketing authorization.
By working with Boyds to obtain SME status in the EU, SMEs can benefit from a range of incentives, including:
- Regulatory, administrative and procedural assistance from the Agency’s SME office including SME briefing meetings
- Fee reductions for scientific advice, scientific services, inspections and establishment of maximum residue limits
- Fee exemptions for certain administrative services of EMA
- Deferral of the fee payable for an application for marketing authorization or related inspection
- Conditional fee exemption where scientific advice is actually taken into account and a marketing authorization application is unsuccessful
- Fee reductions and exemptions for post-authorization procedures
- Certification of quality/non-clinical data for advanced therapy medicinal products (ATMPs) intended for human use
- Product information document translations submitted in the application for marketing authorization
- Waiver of the medical dictionary for regulatory activities (MedDRA) licensing fee when registering EudraVigilance (for micro or small enterprises only)
- Inclusion in the SME public register
Orphan drugs for human use are eligible to access the PRIME scheme, and the fee for scientific advice is fully waived.
Further financial incentives include a 90% fee reduction for good manufacturing practice (GMP), good clinical practice (GCP), good laboratory practice (GLP), or pharmacovigilance inspections requested by the EMA, and it is possible to defer payment of pre-authorization inspection fees.
Latest guidance
The EMA published updated guidance for micro, small and medium sized enterprises and can be viewed here.
If you think you might be eligible, and would like to discuss applying for SME status in the EU with Boyds, please get in touch.
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