Achieving Small Medium Enterprises (SME) status

A Small Medium Enterprises (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. 

However, 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).

In the EMA SMEs can apply to Health Authorities for administrative and financial assistance. This includes:

  • Research funding, competitiveness and innovation funding and similar national support programmes that could otherwise be banned as unfair government support (‘state aid’ – see block exemption regulation)

  • Fewer requirements or reduced fees for EU administrative compliance

Small Medium Enterprises (SME)

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

Following BREXIT, UK based companies are no longer eligible for qualification as SMEs under the European system run by EMA. FYI EU-based SME regulatory consultancies may seek to benefit from the provisions of the SME Regulation on behalf of non-EU based pharmaceutical companies/clients if both they and the client meet the SME criteria; this provision would exclude e.g. non-EU regulatory consultancies or non-EU entities part of a group which have a legal entity based in the EU.

The MHRA does offer some Payment easements and waivers for Small and Medium Companies, these include applications for major and complex marketing authorisations, and manufacturers’ or wholesale dealer’s licences.

JensonR+ can assist with applying and renewing your Small Medium Enterprises (SME) status, to support your commercial goals.

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