2. The holder of the authorisation shall—
(a)provide and maintain such staff, premises, equipment and facilities for the handling, storage and distribution of the investigational medicinal products which he handles, stores or distributes under his authorisation as are necessary to maintain the quality of the investigational medicinal products;
(b)not use for such purposes premises other than those specified in the authorisation or which may be approved from time to time by the licensing authority; and
(c)ensure that any arrangements he makes with a person for the storage and distribution of the investigational medicinal products are adequate to maintain the quality of those products.