SCHEDULE 3 STANDARD PROVISIONS WHICH MAY BE INCORPORATED IN A MANUFACTURER'S LICENCE WHICH RELATES TO VACCINES, TOXINS OR SERA

PART 3 STANDARD PROVISIONS WHICH MAY BE INCORPORATED IN A MANUFACTURER'S LICENCE WHICH RELATES TO BCG VACCINES
5 (1) The licence holder shall arrange for all persons engaged in the production of BCG vaccine to be examined clinically by a doctor and where appropriate, radiologically and bacteriologically, at least every twelve months and whenever such a person shows signs of ill health.
(2) The licence holder shall ensure (as far as paragraph (c) below is concerned, in so far as is reasonably practicable), that persons falling within the following descriptions shall not engage in the production of BCG vaccine, that is to say—
(a) persons examined as aforesaid who are found to be suffering from active or potentially active tuberculosis lesions,
(b) persons who show a negative reaction when tested with tuberculin, or
(c) persons who are in close contact with a person who is suffering from any active form of tuberculosis.
(3) If on examination in accordance with subparagraph (1), a person engaged in the production of BCG vaccine is found to be suffering from active or potentially active tuberculosis lesions, then, after that person has been removed from the separate premises or separate parts of premises referred to in paragraph (1), the licence holder shall—
(a) make arrangements for those separate premises or separate parts of premises and all equipment used in the production of BCG vaccine to be treated in such a manner as to remove the risk of contamination of the vaccine; and
(b) cease to use any unsealed cultures of BCG and all current preparations of BCG vaccine which may have become contaminated with other Mycobacterium tuberculosis organisms.