Achieving Small Medium Enterprises (SME) Status

Achieving Small Medium Enterprise (SME) status comes with numerous benefits, including funding support, reduced regulatory requirements and reduced fees. Jenson R+ can support your company in achieving and maintaining SME status, and in maximising the benefits this status brings.  

The European Medicines Agency (EMA) provides incentives and support for micro, small and medium-sized enterprises, collectively known as SMEs, that are developing medicines for human or veterinary use, in order to promote innovation and the development of new medicines. These include:

SME status
  • Research funding, competitiveness and innovation funding and similar national support programmes that could otherwise be banned as unfair government support

  • Fewer requirements or reduced fees for EU administrative compliance

  • Additional access to briefing meetings or to ask questions about regulations, administrative requirements or procedures, as well as targeted training events

  • Free translation assistance for product information

Enterprises must apply for this status before applying for help from Health Authorities.

An SME is defined by the number of staff and annual turnover or balance sheet total. You must satisfy both the employee numbers and turnover/balance sheet.

Even if an enterprise meets these criteria, it may not be eligible if it has access to significant additional resources (e.g., because it is owned by, linked or partnered with a larger enterprise).

Following Brexit, UK-based companies are no longer eligible for qualification as SMEs under the European system run by the EMA. However, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) also offers a number of benefits to UK based SMEs. These include:

  • Deferral of a portion of application fees until Marketing Authorisation (MA) procedure closure (dependent on procedure type)

  • Deferral of 50% of fees for applications for Manufacturers’ or Wholesale Dealer’s licences, traditional herbal medicines registrations and complex variations to traditional herbal registrations, until 12 months after initial application.

  • Deferral of inspection fees

  • Some provision for payment waivers

Numerous markets outside of the UK and EU, such as the US and Canada, also offer benefits and incentives to SMEs.

JensonR+ have expertise across global markets through regulanet®, our partner network that has representation in over 90 countries throughout the world and provides a diverse number of services and product expertise across the pharmaceutical and medtech areas.

Get in touch with us to find out more