4.—(1) The address of each of the premises where the manufacturing, assembling or importation operations to which the application relates, including any testing associated with manufacture, assembly or import, are or are to be carried out.
(2) The address of each of the premises where the proposed holder of the authorisation proposes to store investigational medicinal products or from which he proposes to distribute them.
(3) A statement indicating the facilities and equipment available at each of the premises referred to in sub-paragraphs (1) and (2), for storing the investigational medicinal products on, and distributing them from or between, such premises.
(4) A separate statement in respect of each of the premises referred to in sub-paragraphs (1) and (2), of the manufacturing, assembling or importation operations capable of being carried out at those premises with their existing facilities. Each statement shall specify the classes of investigational medicinal products to which the operations are relevant.
(5) A separate statement in respect of each of the premises referred to in sub-paragraphs (1) and (2), of the facilities and equipment available at those premises for carrying out each stage of the manufacturing, assembling or importation operations described in sub-paragraph (4) of this paragraph.