UNITED KINGDOM STATUTORY INSTRUMENT
1992 No. 2846
MEDICINES
The Medicines (Standard Provisions for Licences and Certificates) Amendment Regulations 1992
Made 12th November 1992
Laid before Parliament 20th November 1992
Coming into force 11th December 1992
The Secretary of State concerned with health in England, the Secretaries of State respectively concerned with health and with agriculture in Wales and in Scotland, the Minister of Agriculture, Fisheries and Food, the Department of Health and Social Services for Northern Ireland and the Department of Agriculture for Northern Ireland, acting jointly, in exercise of powers conferred upon them by section 47(1) of the Medicines Act 1968or, as the case may be, those conferred by the said provisions and now vested in themand of all other powers enabling them in that behalf, after consulting such organisations as appear to them to be representative of interests likely to be substantially affected by these Regulations, hereby make the following Regulations:
S-1
Citation, commencement and interpretationCitation, commencement and interpretation
1.—(1) These Regulations may be cited as the Medicines (Standard Provisions for Licences and Certificates) Amendment Regulations 1992, and shall come into force on11th December 1992.
(2) In these Regulations, “the Principal Regulations” means the Medicines (Standard Provisions for Licences and Certificates) Regulations 1971.
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Amendment of regulation 2(1) of the Principal RegulationsAmendment of regulation 2(1) of the Principal Regulations
2.—(1) Regulation 2(1) of the Principal Regulations (interpretation) shall be amended in accordance with the following provisions of this regulation.
(2) After the definition of “advertisement” there shall be inserted the following definition—
““allergen product” means any product which is intended to identify or induce a specific acquired alteration in the immunological response to an allergising agent;”
(3) After the definition of “BCG vaccine”, there shall be inserted the following definition—
““blood product” means any industrially prepared medicinal product for human use derived from human blood or human plasma and includes albumin, coagulating factors and immunoglobulins of human origin, but does not include whole human blood, human plasma or blood cells of human origin;”
(4) After the definition of “clinical trial certificate of right” and “animal test certificate of right”, there shall be inserted the following definitions—
““expiry date”, in relation to a medicinal product, means the date after which the medicinal product should not be used;
“good manufacturing practice” means the part of quality assurance which ensures that medicinal products are consistently produced and controlled to the quality standards appropriate to their intended use, the principles and guidelines of which are specified in Chapter II of Commission Directive 91/356/EEC;”.
(5) After the definition of “parenteral administration”, there shall be inserted the following definition—
““relevant period” means the period of five years from the date of certification of the relevant batch referred to in paragraph 16(3)(b) of Schedule 2 to these Regulations or the period of one year from the expiry date of the relevant batch, whichever expires later;”
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Insertion of regulation 3A into the Principal RegulationsInsertion of regulation 3A into the Principal Regulations
3. After regulation 3 of the Principal Regulations there shall be inserted the following regulation—
“Standard provisions for product licences, including product licences of right, for blood products and immunological medicinal products for human use
3A. In addition to the standard provisions for product licences set out in Part I of Schedule 1 to these Regulations—
(a) the standard provisions for product licences, including product licences of right, in relation to blood products shall be those provisions set out in paragraphs 1 and 2 of Schedule 1A to these Regulations, and
(b) the standard provisions for product licences, including product licences of right, in relation to vaccines, toxins, serums or allergen products for human use shall be those provisions set out in paragraph 3 of Schedule 1A to these Regulations.”.
Insertion of Schedule 1A into the Principal Regulations
4. After Schedule 1 to the Principal Regulations, there shall be inserted the following—
“SCHEDULE 1A
Regulation 3A
ADDITIONAL STANDARD PROVISIONS FOR PRODUCT LICENCES INCLUDING PRODUCT LICENCES OF RIGHT RELATING TO BLOOD PRODUCTS AND CERTAIN IMMUNOLOGICAL MEDICINAL PRODUCTS
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)
(a) are properly validated,
(b)
(b) attain batch-to-batch consistency, and
(c)
(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)
(i) signed by the qualified person referred to in paragraph 16 of Schedule 2 to these Regulations,
(ii)
(ii) kept for the relevant period, and
(iii)
(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.”.
Amendment of Schedule 2 to the Principal Regulations
5.—(1) Schedule 2 to the Principal Regulations (standard provisions for manufac turer’s licences including manufacturer’s licences of right) shall be amended in accordance with the following paragraphs of this regulation.
(2) At the end of paragraph 3, there shall be inserted the words “and, in relation to medicinal products for human use, shall conduct all such operations in accordance with the principles and guidelines of good manufacturing practice”.
(3) After paragraph 3, there shall be inserted...
