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The Medicines for Human Use (Manufacturing, Wholesale Dealing and Miscellaneous Amendments) Regulations 2005

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PART 1STANDARD PROVISIONS WHICH MAY BE INCORPORATED IN A MANUFACTURER'S LICENCE WHICH RELATES TO VACCINES

1.  (1)  The licence holder shall provide separate premises or separate parts of premises referred to in this Part as “the designated premises”, for the activities specified in the following sub-paragraphs, namely—

(a)the production and the testing involved in the production of cell cultures for use in the production of vaccine;

(b)the production and the testing involved in the production of vaccine prepared from viruses; and

(c)the production and the testing involved in the production of vaccine prepared from micro-organisms or detoxified microbial toxins,

and shall ensure that only persons necessary to each of the above mentioned activities shall have access to the designated premises provided for that activity.

2.  The licence holder shall ensure that any procedure which, in the course of any of the activities specified in the preceding paragraph involves or might involve—

(a)the presence of transmissible agents; or

(b)the use of cell cultures, animal tissues or micro-organisms,

other than those from which the vaccine is produced, shall not be carried out in the designated premises referred to in paragraph 1.

3.  The licence holder shall ensure that no person who has been in contact with transmissible agents or experimental animals (other than those connected with the vaccine being produced in the designated premises referred to in paragraph 1) shall enter the designated premises on the same day that such contact has occurred.

4.  Before an animal is used in the production of a vaccine, the licence holder shall take all reasonable steps to ensure that it is free from disease, and to that end shall keep the animal in quarantine and under observation for such period as the licensing authority may specify.

5.  The licence holder shall ensure—

(a)that animals used in the production of vaccine are isolated and shall provide separate premises (not being the designated premises referred to in paragraph 1) for this purpose; and

(b)that only persons engaged in the production and testing of vaccines or in the maintenance of animals or premises shall have access to the separate premises in which the animals are isolated.

6.  The licence holder shall provide a separate room in the premises referred to in paragraph 5 which is capable of being washed and disinfected and which is to be used for the purpose of—

(a)the inoculation of animals; and

(b)the collection of material to be used in the preparation of vaccine.

7.  Without prejudice to any other requirements to keep records, where vaccines contain or might contain micro-organisms or microbial toxins, the licence holder shall keep a durable record, readily available for inspection by a person authorised by the licensing authority, of the origin, properties and characteristics of the cell cultures used in the production of those vaccines and shall ensure that that record is not destroyed for a period of five years from the date when the relevant production occurred.

8.  Nothing in this Schedule 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.

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