Payment easements and waivers for Small and Medium Companies
Updated 20 November 2023
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This publication is available at https://www.gov.uk/government/publications/mhra-fees/payment-easements-and-waivers-for-small-and-medium-companies
Payment Easements for Small Companies
The Agency’s fees legislation currently has provision for some payment easements for small companies in relation to a number of capital fees.
Definition of a small Company
For the purpose of these regulations, a company is a small company if, for the financial year before that in which the application is made, the amount of its turnover for the financial year is not more than the amount for the time being specified under the heading “small company” in section 382(3) (qualification of a company small) of the Companies Act 2006 (as amended) and the condition in paragraph (3)(a) or (b) is met:
(a) the company’s balance sheet total (as defined in section 382(5) of that Act) is not more than the amount for the time being specified under the heading ‘small company’ in section 382(3) of that Act; or
(b) the average number of persons employed by the company in the financial year before that in which the application is made (determined on a weekly basis) does not exceed the number for the time being specified under the heading ‘small company’ in section 382(3) of that Act.
The Medicines (Products for Human Use) (Fees) Regulations 2016
Changes resulting from the UK leaving the EU
If your company is applying for SME status and you have questions about the impact of the UK leaving the EU, please refer to The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (legislation.gov.uk) before contacting MHRA.
The recent volume of applications has increased significantly and you may find your answer faster, in the above guidance.
Criteria for Small Company
Payment Easements 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 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 Manufacturers’ or Wholesale Dealer’s licences
50% at time of application with 50% payable 12 months after that time.
The “50% rule” at time of application then 50% payable 12 months after also applies to the payment of applications for traditional herbal medicines registrations and applications for complex variations to traditional herbal registrations.
In respect to inspection fees in connection with applications for a marketing authorisation, traditional herbal registration, manufacturer’s licence, manufacturer’s authorisation 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.
The Medicines (Products for Human Use) (Fees) Regulations 2016
Payment Waivers for Small and Medium Companies (SME)
The Agency’s fees legislation currently has provision for some payment waivers for small and medium companies.
Definition of a Medium Company
For the purpose of these Regulations, a company is a medium company if, for the financial year before that in which the application is made, the total value of products it has sold or supplied for the financial year is not more than the amount for the time being specified in item 1 in section 465(3) of the Companies Act 2006(122) (qualification of company as medium); and
(a) the company’s balance sheet total as defined in section 465(5) of the Companies Act 2006 is not more than the amount for the time being specified in item 2 in section 465(3) of that Act; or
(b) the average number of persons employed by the company in the financial year before that in which the application is made (determined on a weekly basis) does not exceed the number for the time being specified in item 3 in section 465(3) of that Act.
Criteria for Medium Company
Payment Waivers Available for Small and Medium Companies
- Fees payable in connection with a meeting mentioned in any of regulations 4 to 10, as set out in the Human Medicines (Amendment 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 to apply for Small and Medium Company status
Download and complete the customer payment easement form and email this, along with a copy of your latest audited accounts, to: sales.invoices@mhra.gov.uk.
Applications for SME status must be made prior to application.
If conditions specified are met, then it should be assumed that SME status will be approved.
MHRA Finance department will assess application and confirm if 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 Finance with their application.