Applications relating to products in well-established medicinal use
This section has no associated Explanatory Memorandum
54.—(1) This regulation applies if an applicant for a UK marketing authorisation for a relevant medicinal product is able to demonstrate that the active substances of the product have been in well-established medicinal use within the European Union for at least 10 years, with recognised efficacy and an acceptable level of safety in terms of the conditions set out in Annex I to the 2001 Directive.
(2) The applicant must provide information in accordance with Article 10a of the 2001 Directive.