Regulation 50I Applications relating to conditional marketing authorisations ...F1F3
This regulation applies in relation to an application for F2a UKMA(UK)(Category 1) for a relevant medicinal product which falls within paragraph (2).
A relevant medicinal product falls within this paragraph if it is—
aimed at the treatment, prevention or diagnosis of seriously debilitating or life-threatening diseases; or
to be used in emergency situations, in response to public health threats.
The applicant for a UK marketing authorisation to which this regulation applies may request that the licensing authority grant a conditional marketing authorisation if—
comprehensive clinical data referring to the safety and efficacy of the medicinal product have not been supplied; and
the applicant can demonstrate that—
the positive therapeutic effects of the product outweigh the risks to the health of patients or of the public associated with the product,
it is likely that the applicant will be in a position to provide the comprehensive clinical data,
unmet medical needs will be fulfilled, and
the benefit to the public health of the immediate availability on the market of the medicinal product concerned outweighs the risk inherent in the fact that additional data are still required.
In this regulation, “unmet medical needs” means medical needs in relation to a condition for which there exists no satisfactory method of diagnosis, prevention or treatment authorised in the United Kingdom, or, even if such method exists, in relation to which the medicinal product concerned will be of major therapeutic advantage to those affected.
The applicant for a UK marketing authorisation to which this regulation applies must include in the application material which demonstrates that the criteria in paragraph (3)(b) are met.
Annotations
Textual amendments
- F1
Regs. 50A-50J inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 53 (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 40(a)-(g)); 2020 c. 1, Sch. 5 para. 1(1)
- F2
Words in reg. 50I(1) substituted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 33(b)
- F3
Words in reg. 50I heading omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 33(a)