The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019

Obligation of licensing authority in case of change of classification

70.  After regulation 64, insert—

“Obligation of licensing authority in case of change of classification

64A.— (1) In this regulation, “classification”, in relation to a medicinal product, means the term of the product’s UK marketing authorisation which determines the way in which the product is to be made available, as described in regulation 62(1).

(2) This regulation applies where—

(a) the licensing authority grants or varies a UK marketing authorisation;

(b) the grant or variation of the UK marketing authorisation involves a change of the classification of the medicinal product to which the authorisation relates; and

(c) the application for the UK marketing authorisation or variation was supported by the results of significant pre-clinical tests or clinical trials relating to the proposed classification.

(3) Where this regulation applies, the licensing authority may not, for the period of one year beginning with the date on which the UK marketing authorisation was granted or varied, refer to the results of the tests or trials referred to in paragraph (2)(c) when examining an application by another applicant or UK marketing authorisation holder for a change of classification of the same kind as that to which the tests or trials relate.”.