Regulation 50H Applications relating to advanced therapy medicinal productsF1

This regulation applies in relation to an application for F2a UKMA(UK)(Category 1) for a relevant medicinal product which is an advanced therapy medicinal product.

The applicant for a UK marketing authorisation to which this regulation applies must, in addition to the material specified in regulation 50, provide to the licensing authority information about the measures the applicant envisages putting in place to ensure the follow up of the efficacy of the product and of any adverse reactions to it.

In relation to an application for F3a UKMA(UK)(Category 1) for a combined advanced therapy medicinal product, the applicant must, in addition to the material specified in regulation 50 and paragraph (2), provide to the licensing authority evidence of conformity with the requirements of the Medical Devices Regulations 2002, including, where available, the results of the assessment of a notified body in accordance with those Regulations.