Paragraph 11

Where the authorisation relates to the assembly of an investigational medicinal product F1or EAMS medicinal product, and the holder of the authorisation supplies that investigational medicinal product or EAMS 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 or EAMS medicinal product has been so supplied.