
1 

(1) These Regulations may be cited as the Medicines (Standard Provisions for Licences and Certificates) Amendment (No. 2) Regulations 1992, and shall come into force on 1st January 1993.
(2) In these Regulations, “the Principal Regulations” means the Medicines (Standard Provisions for Licences and Certificates) Regulations 1971.
2 

(1) Schedule 5 to the Principal Regulations (standard provisions for product licences including product licences of right relating to certain medicinal products) shall be amended in accordance with the following provisions of this regulation.
(2) There shall be inserted at the beginning of paragraph 3 of Part I the words “Subject to paragraph 3A of this Part of this Schedule,”.
(3) After paragraph 3 of Part I there shall be inserted the following paragraph—“
3A 
Paragraph 3 of this Part of this Schedule shall not apply in respect of a batch of—
(a) blood products,
(b) live vaccines,
(c) immunological medicinal products used in the primary immunization of infants or of other groups at risk,
(d) immunological medicinal products used in public health immunization programmes, or
(e) new immunological medicinal products or immunological medicinal products manufactured using new or altered kinds of technology or new for a particular manufacturer, during a transitional period normally specified in the marketing authorisation, which has been previously examined by the competent authority of a member State other than the United Kingdom and declared to be in accordance with the specifications in a marketing authorisationwhich complies with Council Directive 65/65/EEC as amended.”.
(4) In paragraph 4 of Part I for the words “the preceding paragraph” there shall be substituted the words “paragraph 3 of this Part of this Schedule”.
Virginia Bottomley
Secretary of State for Health
18th December 1992David Hunt
Secretary of State for Wales
21st December 1992Fraser of Carmyllie
Minister of State, Scottish Office
21st December 1992In Witness whereof the Official Seal of the Minister of Agriculture, Fisheries and Food is hereunto affixed on 22nd December 1992.
John Selwyn Gummer
Minister of Agriculture, Fisheries and Food
Sealed with the Official Seal of the Department of Health and Social Services for Northern Ireland on 18th December 1992.
F. A. Elliott
Permanent Secretary
Sealed with the Official Seal of the Department of Agriculture for Northern Ireland on 18th December 1992.
W. J. Hodges
Permanent Secretary
