Paragraph 4

F1Except where the application relates to an MM investigational medicinal product or a POC investigational medicinal product, 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.

Where the application relates to an MM investigational medicinal product, the address of the MM (IMP) control site and the location of any testing associated with manufacture or assembly that is, or is to be, carried out.

Where the application relates to a POC investigational medicinal product, the address of the POC (IMP) control site and the location of any testing associated with manufacture or assembly that is, or is to be, carried out.

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.

Where the application relates to an MM investigational medicinal product, the address of each of the premises other than the MM (IMP) control site where the proposed holder of the manufacturing authorisation (MM) proposes to store components or equipment to be used in the manufacturing process.

Where the application relates to a POC investigational medicinal product, the address of each of the premises other than the POC (IMP) control site where the proposed holder of the manufacturing authorisation (POC) proposes to store components or equipment to be used in the manufacturing process.

A statement indicating the facilities and equipment available at each of the premises referred to in sub-paragraphs F4(1) to (2B) (as applicable), for storing the investigational medicinal products on, and distributing them from or between, such premises.

A separate statement in respect of each of the premises referred to in sub-paragraphs F5(1) to (2B) (as applicable), 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.

A separate statement in respect of each of the premises referred to in sub-paragraphs F6(1) to (2B) (as applicable), 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.