The Medicines (Applications for Manufacturer’s and Wholesale Dealer’s Licences) Amendment Regulations 1993

Amendment of Schedule 2 to the principal Regulations

3.  Schedule 2 to the principal Regulations (particulars required on an application for the grant of a wholesale dealer’s licence) shall be amended by inserting after paragraph 8 the following paragraphs—

“8A.   Where the licence is to relate to products to which Chapters II to V of the 1965 Directive apply, the name and address and degrees, diplomas or qualifications of a responsible person who is to carry out the functions specified in paragraph 7A(2) of Schedule 3 to the Medicines (Standard Provisions for Licences and Certificates) Regulations 1971(1) (in this and the following paragraph referred to as “the Standard Provisions Regulations”).

8B.   Where the licence is to relate to products to which Chapters II to V of the 1965 Directive apply, details of an emergency plan which satisfies the requirements of paragraph 4A of Schedule 3 to the Standard Provisions Regulations.

8C.   Where the licence is to relate to products to which Chapters II to V of the 1965 Directive apply, a statement of any arrangements for keeping records, either in the form of invoices or on computer or in any other form, relating to all products received or dispatched.”.

(1)

S.I. 1971/972. The relevant amending instrument is S.I. 1993/833.