Are you a small or medium-sized enterprise (SME)? If so the Medicines and Healthcare Products Regulatory Agency (MHRA) fees legislation currently has provision for some payment waivers for SMEs.

What is the criteria for a small or medium company?

The criteria that needs to be met in the UK in order to be defined as a SME, is as follows:

What payment easements are available for small companies?

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.

In respect to inspection fees in connection with applications for a MA, traditional herbal registration, manufacturer’s licence or wholesale dealer’s licence, the fee payable is 50% within 14 days following receipt of written notice requiring those fees, with 50% payable 12 months after that date.

See detailed legislation on fees here: The Medicines (Products for Human Use) (Fees) Regulations 2016.

What payment waivers are available for SMEs?
  • Fees payable in connection with a meeting mentioned in any of regulations 4 to 10, as set out in the Human Medicines (Amendments etc.) (EU Exit) Regulations 2020.
  • 100% of initial application fee where the licensing authority grants an orphan marketing authorisation.
  • 100% of application for variation of orphan marketing authorisation made within first 12 months of the date of grant.

This does not apply to an application to authorise use of the medicinal product in a new therapeutic area which does not meet the orphan criteria listed in regulation 50G(2) of the Human Medicines Regulations.

How do I apply for SME status?

Send an email to the MHRA (sales.invoices@mhra.gov.uk) detailing your request and attach a copy of the company’s latest audited accounts. Applications for SME status must be made prior to submitting an application for a scientific advice meeting.

The MHRA Finance Department will assess the application and confirm if the company meets the necessary requirements, and so is eligible to receive relevant easements or waivers. Should SME status be approved, the company must then submit the approval letter from the MHRA Finance Department with their application.

If you would like to discuss how Fusion Pharma can support you with gaining SME status, please email us at hello@fusion-pharma-limited.com or phone us on +44 (0) 203 1379 799.