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17. After regulation 50J (applications in relation to medicinal products containing or consisting of genetically modified organisms)(1) insert—
50K.—(1) This regulation applies in relation to an application for a UK marketing authorisation for a relevant medicinal product that is a POC medicinal product.
(2) 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.”.
Inserted by S.I. 2019/775.
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