The Medicines (Standard Provisions for Licences and Certificates) Amendment Regulations 1992

Amendment 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(1);”.

(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;”

(1)

OJ No. L193, 17.7.91, p.30.