PART 1U.K.INTERPRETATION
In this Schedule, “product specification” means—
(a)in the case of an investigational medicinal product manufactured before a request for authorisation to conduct the clinical trial involving those products has been made in accordance with regulation 17 or any equivalent provisions in any EEA State other than the United Kingdom, the specification for that product provided by the person who is to act as the sponsor of the proposed clinical trial,
(b)in the case of an investigational medicinal product manufactured for the purpose of export, the specification for that product provided by the person to whose order the products are manufactured, or
(c)in any other case, the specification for an investigational medicinal product contained in the investigational medicinal product dossier for that product.