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.