Regulation 46A Labelling of non-investigational medicinal productsF1

Subject to paragraph (2), a non-investigational medicinal product must be labelled in accordance with the requirements set out in regulation 46, and any reference in that regulation to “investigational medicinal product” is to be construed as a reference to “non-investigational medicinal product” accordingly.

Regulation 46(4) does not apply to a non-investigational medicinal product which falls within sub-paragraph (a) of regulation 46(3).