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The Medicines for Human Use (Manufacturing, Wholesale Dealing and Miscellaneous Amendments) Regulations 2005
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PART 4STANDARD PROVISIONS WHICH MAY BE INCORPORATED IN A MANUFACTURER'S LICENCE WHICH RELATES TO TOXINS
1. The licence holder shall provide separate premises or separate parts of premises for the production and the testing involved in the production of toxins and shall ensure that only persons necessary to the production and testing of toxins (or related toxoids) shall have access to the separate premises or separate parts of those premises.
2. Nothing in paragraph 1 shall operate so as to restrict the right of access to any premises of any person who is duly authorised by the enforcement authority to enter those premises in accordance with section 111 of the Act.
3. The licence holder shall ensure that any procedure which in the course of the production and testing referred to in the previous paragraph involves or might involve the presence of micro-organisms, plants or animals other than those from which the toxins are to be produced, shall not be carried out in the separate premises or separate parts of premises referred to in paragraph 1.
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