SME application and status.
What is SME status?
Micro, Small and Medium-sized Enterprises (SMEs) can apply to the EMA and/or the MHRA to register for SME status which provides incentives to encourage these companies innovate and develop new medicines.
SME Thresholds (Commission recommendation 2003/361/EC).
What size enterprises meet EMA Eligibility for SME status?
To be eligible for SME status, companies must be based in the EEA and meet a combination of headcount, plus annual turnover, or annual balance sheet criteria.
Non-EEA based companies can also still benefit indirectly through an EU based consultancy that has SME status, though the company thresholds below must still be met.
What are the EMA incentives?
Fee incentives in the form of a reduction, or in some cases exemption, from fees are possible for the following procedures:
- Scientific Advice
- Pre- and post-approval Inspections
- Initial MAAs and some post approval submissions
- MedDRA subscription fee waiver
Translation of Product Information into EU languages (except Icelandic and Norwegian) as part of the initial MAA.
Briefing meetings with EMA.
Receipt of EMA SME newsletters and invitations to free EMA SME training events.
SME office contact for questions about EMA submission requirements or EU legislation.
How can Arriello help your company obtain EMA SME status?
Arriello is itself an EMA registered SME, which means we can pass on these incentives and allow our non-EU based clients that meet the eligibility criteria to indirectly obtain SME status through our own SME designation.
We work with the EMA SME office to assist you with preparing your application and consult with them to provide all the financial documentation needed to support a SME application, regardless of whether you are based in the EEA or outside.
What is MHRA SME Status?
The MHRA offers different incentives from the EMA for small and medium companies and the criteria and incentives for each are described below. The difference between the EMA and MHRA SME status is that the MHRA will accept applications from companies in ALL geographies – they do not restrict applications to UK or EU based companies only.
What are the MHRAs SME Eligibility Criteria?
Small Companies.
- Turnover not more than £10.2 million
- Balance sheet total not more than £5.1 million
- Not more than 50 employees
Medium Companies.
- Turnover not more than £36 million
- Balance sheet total not more than £18 million
- Not more than 250 employees
What are the MHRAs SME Fee Incentives?
Small Companies ONLY.
Major applications.
25% of the application fee for a new active substance at the time of the application with the remaining 75% payable within 30 days of the Marketing Authorisation (MA) being determined.Complex applications.
50% of the application fee for a new active substance at the time of the application with the remaining 50% payable within 30 days of the MA being determined.Applications for Manufacturer’s or Wholesale Dealer’s licences.
50% at time of application with 50% payable 12 months after that time.
Small & Medium Companies Payment Waivers.
Major applications.
100% of application for variation of orphan marketing authorisation made within first 12 months of the date of grant.- Complex applications.
100% of application for variation of orphan marketing authorisation made within first 12 months of the date of grant.
- Applications for Manufacturer’s or Wholesale Dealer’s licences.
100% of application for variation of orphan marketing authorisation made within first 12 months of the date of grant.
How can Arriello help your company obtain and benefit from MHRA SME status?
We work with the MHRA and can prepare, submit, and consult with them on behalf of your company to apply and obtain your MHRA SME status, allowing you to directly benefit from their fee incentives.
Reach out to us through the form or chat for a consultation on how to obtain MHRA or EMA SME status.
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What our clients say about us.
Arriello has highly knowledgeable staff in all countries with a very professional attitude. They are very fast in responding when needed.
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