Paragraph 54 A set of changes
Unless paragraph 55 applies, the fee payable under regulation 25(1) in connection with a set of proposed changes to the labelling or the package leaflet of a medicinal product is—
F1£992, in respect of a product which is the subject of a United Kingdom marketing authorisation (other than a parallel import licence); and
F2£440, in respect of a product which is the subject of a parallel import licence.
If the proposed changes in respect of a product to which the fee in sub-paragraph (1)(a) applies are submitted in accordance with the National Guidance on labels and leaflets self-certification, the fee payable under regulation 25(1) is F3£224.
For the purpose of this paragraph—
changes are submitted in accordance with the National Guidance on labels and leaflets self-certification if they are of a type described in the National Guidance on labelling and patient information leaflets for self-certification and comply with the conditions set out in relation to those changes in that Guidance; and
the “National Guidance on labelling and patient information leaflets for self-certification” means the documents entitled “Guidance on changes to labelling and patient information for self-certification” and “Guidance on changes to labelling for self certification – compliance with Article 56(a) of the 2001 Directive – inclusion of Braille on the labelling” published by the licensing authority and available on its website M1.
Annotations
Textual amendments
- F1
Sum in Sch. 2 para. 54(1)(a) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(26)(a)(i)
- F2
Sum in Sch. 2 para. 54(1)(b) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(26)(a)(ii)
- F3
Sum in Sch. 2 para. 54(2) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(26)(b)
Marginal citations
- M1
Copies of the documents can be downloaded from the licensing authority's website at www.mhra.gov.uk or obtained by writing to the licensing authority at 151 Buckingham Palace Road, London, SW1W 9SZ or by sending an email to [email protected].