PART 2STANDARD PROVISIONS WHICH MAY BE INCORPORATED IN A MANUFACTURER'S LICENCE WHICH RELATES TO SMALLPOX VACCINES
1. The licence holder shall ensure that animals used in the production of smallpox vaccine—
(a)shall only be inoculated on a part of the skin that has been depilated and cleansed and which cannot be soiled by urine or faeces, and
(b)are kept under observation for 28 days after the collection of the vaccinal material.
2. Should any animal during the 28 day period referred to in paragraph 1 be found to be suffering from any infection other than vaccinia or show serious or persistent signs of ill health, vaccinal material obtained from that animal shall not be used in the production of smallpox vaccine.
3. Where it is necessary for an animal which has been inoculated for use in the production of smallpox vaccine to be killed, the licence holder shall ensure that—
(a)the vaccinal material is collected immediately after the animal has been killed;
(b)if the licensing authority so directs, a post-mortem examination of the carcass of the animal is made by a person with experience of the diseases of the particular animal which has been killed;
(c)a durable record of the examination is made and retained for a period of five years from the date when the animal was killed, and kept readily available for inspection by a person authorised by the licensing authority; and
(d)where the examination indicates that the animal was suffering from diseases other than vaccinia, no vaccinal material obtained from that animal is used in the production of smallpox vaccine.