The Medicines (Standard Provisions for Licences and Certificates) Amendment (No. 2) Regulations 1992

• Citation: S.I. 1992/3272
• Sections: 2

Section 1 Citation, commencement and interpretation

(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 .

Section 2 Amendment of Schedule 5 to the Principal Regulations

(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 authorisation

which 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”.