Regulation 4 Insertion of Schedule 1A into the Principal Regulations

After Schedule 1 to the Principal Regulations, there shall be inserted the following—

“SCHEDULE 1A

ADDITIONAL STANDARD PROVISIONS FOR PRODUCT LICENCES INCLUDING PRODUCT LICENCES OF RIGHT RELATING TO BLOOD PRODUCTS AND CERTAIN IMMUNOLOGICAL MEDICINAL PRODUCTS

Regulation 3A

Blood products

1

The licence holder shall take all necessary measures to ensure that the manufacturing and purifying processes used in the preparation of the blood products to which the licence relates—

(a)

are properly validated,

(b)

attain batch-to-batch consistency, and

(c)

guarantee, in so far as the state of technology permits, the absence of specific viral contamination,

and shall take all necessary measures to ensure that appropriate records relating to relevant control measures are—

(i)

signed by the qualified person referred to in paragraph 16 of Schedule 2 to these Regulations,

(ii)

kept for the relevant period, and

(iii)

if so requested by the licensing authority, submitted to the licensing authority.

2

The licence holder shall take all necessary measures to ensure that the manufacturer of the blood products to which the product licence relates notifies the licensing authority of the method or methods used to reduce or eliminate pathogenic viruses liable to be transmitted by the blood products.

Immunological products

3

The licence holder shall take all necessary measures to ensure that the processes used in the production of vaccines, toxins, serums or allergen products to which the product licence relates—

(a)

are properly validated, and

(b)

attain batch-to-batch consistency,

and shall take all necessary measures to ensure that appropriate records relating to control measures are—

(i)

signed by the qualified person referred to in paragraph 16 of Schedule 2 to these Regulations,

(ii)

kept for the relevant period, and

(iii)

if so requested by the licensing authority, submitted to the licensing authority.”.