Regulation 20

must provide and maintain, or ensure the provision and maintenance of, such staff, premises, equipment and facilities as are necessary for carrying out, in accordance with the holder’s licence, such stages of the manufacture of the oral dental gum as are undertaken by the holder;

must not carry out any stages of manufacture of the oral dental gum in any premises not specified in the holder’s licence;

must provide and maintain, or ensure the provision and maintenance of, such staff, premises, equipment and facilities for the handling and storage of the oral dental gum as are necessary to prevent the deterioration of the oral dental gum while it is in the holder’s ownership, possession or control;

must only use the premises specified in the holder’s licence, or such other premises as may be approved from time to time by the Authority, for handling or storing the oral dental gum;

must carry out, or arrange for a testing laboratory as specified in the holder’s licence to carry out, tests on the oral dental gum to ensure that the oral dental gum complies with the specifications for that oral dental gum as registered under the Act;

must conduct all manufacturing operations in such a way as to ensure that the oral dental gum is of the correct identity and complies with the specifications for that oral dental gum as registered under the Act;

must ensure that any test for determining compliance with the specifications for the oral dental gum as registered under the Act is, unless otherwise provided in the holder’s licence, applied to samples taken after all manufacturing processes have been completed, or at such earlier stage in the manufacture as may be approved by the Authority; and

must maintain records of the following information for at least one year after the expiry date of the oral dental gum, or 5 years after the date of manufacture of the oral dental gum, whichever is the longer: (i)such information relating to the oral dental gum and its manufacture as the Authority may specify in the holder’s licence; (ii)the manufacture of each batch of the oral dental gum and of the tests carried out on every such batch, in the manner specified in the holder’s licence.