Paragraph 44 Variation of manufacturer's authorisations and licences
The fee payable under regulation 19(1) in connection with an application for variation of a manufacturing authorisation or a manufacturer's licence is F1£345 in respect of each variation applied for which constitutes a change to the authorisation or licence not requiring an inspection or medical, scientific or pharmaceutical assessment.
Annotations
Textual amendments
- F1
Sum in Sch. 2 para. 44 substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(19)