# The Human Medicines Regulations 2012, Regulation 58F: Consideration of applications relating to conditional marketing authorisations


(1) If the licensing authority is satisfied in relation to an application to which regulation 50I (applications relating to conditional marketing authorisations) applies that—
(a) the criteria in regulation 50I(3)(b) are met; and
(b) it is otherwise appropriate to grant a UKMA(UK)(Category 1) in respect of the application in accordance with regulation 49(1)(a),
it may grant a UK marketing authorisation which is known as a conditional marketing authorisation.
(2) Where regulation 50I(2)(b) (applications relating to conditional marketing authorisations) applies, the licensing authority may grant a conditional marketing authorisation if, in addition to comprehensive clinical data, comprehensive pre-clinical or pharmaceutical data have not been supplied.
(3) The licensing authority may, of its own motion, propose that a conditional marketing authorisation be granted if, having consulted the applicant for a UK marketing authorisation, it considers that the criteria in regulation 50I(3)(b) are met.
(4) If the licensing authority grants a conditional marketing authorisation in relation to a medicinal product, it may at any time decide that it is appropriate to grant a UK marketing authorisation in relation to that product which is not a conditional marketing authorisation.
(5) If the licensing authority grants a conditional marketing authorisation, the product's summary of product characteristics and package leaflet must include a statement to that effect, and the summary of product characteristics must include the date on which the conditional marketing authorisation is due for renewal.

---
Source: https://www.legislation.gov.uk/uksi/2012/1916/regulation/58F (the official version)
Page: https://openlegislation.uk/human-medicines-regulations-2012/regulation-58F
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.