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18. After regulation 74 (obligation to take account of scientific and technical progress) insert—
74A. The holder of a UK marketing authorisation relating to an MM medicinal product must provide the holder of the manufacturer’s licence (MM) relating to that product with information in order to enable the licence holder to ensure that the manufacturer’s licence (MM) and MM master file relating to the product are consistent with the marketing authorisation at all times.
74B. The holder of a UK marketing authorisation relating to a POC medicinal product must provide the holder of the manufacturer’s licence (POC) relating to that product with information in order to enable the licence holder to ensure that the manufacturer’s licence (POC) and POC master file relating to the product are consistent with the marketing authorisation at all times.”.
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