Paragraph 2

provide and maintain such staff, premises, equipment and facilities for the handling, storage and distribution of the investigational medicinal products F1or EAMS medicinal products which he handles, stores or distributes under his authorisation as are necessary to maintain the quality of the investigational medicinal products or EAMS medicinal products;

not use for such purposes premises other than those specified in the authorisation F2or, in the case of an MM investigational medicinal product, the MM (IMP) master file and in the case of a POC investigational medicinal product, the POC (IMP) master file, or which may be approved from time to time by the licensing authority; and

ensure that any arrangements he makes with a person for the storage and distribution of the investigational medicinal products or EAMS medicinal products are adequate to maintain the quality of those products.