SCHEDULE 7STANDARD PROVISIONS FOR MANUFACTURING AUTHORISATIONS
PART 2PROVISIONS WHICH MAY BE INCORPORATED IN AN AUTHORISATION RELATING TO THE MANUFACTURE OR ASSEMBLY OF INVESTIGATIONAL MEDICINAL PRODUCTS
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Where the authorisation relates to the assembly of an investigational medicinal product, and the holder of the authorisation supplies that investigational medicinal product at such a stage of assembly that does not fully comply with the provisions of the product specification that relate to labelling, that holder of the authorisation shall communicate the particulars of those provisions to the person to whom that investigational medicinal product has been so supplied.