These Regulations made under section 19(3)(b) of the Medicines Act 1968 prescribe the conditions which are to be incorporated in undertakings given by or on behalf of overseas manufacturers of imported medicinal products where applicants are required by the licensing authority to produce the undertakings in connection with applications for product licences. The regulations relate to such matters as the provision of staff, premises and plant for the manufacture, handling and storage of medicinal products, record keeping and the supply of information to holders of product licences.