Applications relating to certain medicinal products that do not qualify as generic etc
This section has no associated Explanatory Memorandum
52.—(1) This regulation applies where—
(a)an application is made for a UK marketing authorisation in respect of a product by reference to another medicinal product as reference medicinal product; and
(b)one or more of the circumstances listed in Article 10(3) of the 2001 Directive applies in respect of the application.
(2) The applicant must provide information in accordance with Article 10(3) and (6) of the 2001 Directive.
(3) Regulation 51(2) shall apply to the application as it applies in relation to an application made in accordance with regulation 51(1).