SME

SME application and status.

What is SME status?

The description of what constitutes a Micro, Small and Medium-sized Enterprise (SME) in the EU is provided in the EU recommendation 2003/361. MHRA has slightly different SME eligibility criteria.

However, companies that meet the relevant requirements can apply to the EMA and/or the MHRA to register for SME status. Following the designation of SME status, incentives are available to encourage these companies to innovate and develop new medicines. To keep benefiting from SME incentives, the SME status must be renewed.

Arriello will be very happy to support you with the renewal process. 

Non-EEA-based companies that meet the SME company requirements, including financial thresholds, can also, indirectly, benefit from the EU SME benefits by applying for SME status via an EU-based consultancy that already holds ME status. 

What size enterprises meet EMA Eligibility for SME status? 

The EMA classifies companies according to their category (autonomous, partnership or linked) as well as their size (number of employees, turnover and balance sheet total) (European Commission. User guide to the SME Definition. Ref. Ares(2020)4648692 – 07/09/2020) 

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.

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What are the incentives that EMA offers?

  • SME office support provides SME briefing meetings. SME office contact is available for questions about EMA submission requirements or EU legislation.

     

  • Fee incentives in the form of a significant fee reductions, exemptions or deferrals from fees are possible for the following procedures:
    • Scientific Advice (90% reduction or 100% reduction with orphan drug designation).
    • Pre- and post-approval Inspections [GLP, GMP, GCP] (90% reduction).
    • Initial MAAs (deferred) and some post-approval submissions.
    • Pharmacovigilance activities.
    • MedDRA subscription fee waiver (only micro- and small enterprises). 

EU National Authority SME support.

Some of the EU Authorities also provide national support to companies with SME status. The countries and benefits, which are managed on an individual country basis, are collated and described on the EMA website (National provisions for SMEs applicable to the pharmaceutical sector (europa.eu)).

  • Certification of quality & non-clinical data for advanced therapy medical products (ATMPs) for human use.

     

  • Translation of Product Information into EU languages (except Icelandic and Norwegian) as part of the initial MAA.

     

  • Information updates: EMA SME newsletters and invitations to free EMA SME training events.

How can Arriello help your company obtain EMA SME status?

Arriello is an EMA-registered SME. This means Arriello can pass on these incentives and allow our non-EU-based clients that meet the SME eligibility criteria to indirectly obtain SME status through our own SME designation.

Whether you are based in the EEA or outside, we will help you prepare your application and associated documentation needed to support your application to the EMA SME office.

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Medicines and Healthcare products Regulatory Agency (MHRA) support for Small and Medium Companies.

What is MHRA SME Status? 

The MHRA offers different incentives from the EMA for small and medium companies. The criteria and incentives for each are described below. A major 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 based companies only. 

What are MHRAs SME Eligibility Criteria and Fee Incentives?

Criteria – Meet two or more of the following:

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?

Arriello can help you to prepare your initial and renewal SME applications for you to submit to  MHRA and benefit from their 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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