The Medicines for Human Use (Manufacturing, Wholesale Dealing and Miscellaneous Amendments) Regulations 2005

Amendments to the Medicines (Renewal Applications for Licences and Certificates) Regulations 1974 U.K.

3.—(1) The Medicines (Renewal Applications for Licences and Certificates) Regulations 1974 are amended as follows.

(2) In Part II of the Schedule (renewal application particulars)—

(a) in paragraph 8, after “a manufacturer's licence“ insert “ where that licence relates to the manufacture or assembly of medicinal products, ”; and

(b) after paragraph 8, insert the following paragraph—

“8A.   In the case of renewal of a manufacturer's licence, where that licence relates to the importation from a third country of medicinal products, the following particulars—

(a) the names and qualifications of the persons under whose supervision the importation operations to be carried out pursuant to the licence will be carried out;

(b) particulars of the arrangement made or to be made for securing the safekeeping, and the maintenance of adequate records in respect of medicinal products to be imported from a third county in pursuance of the licence as renewed;

(c) particulars of the premises on which will be stored medicinal products of the description to which the licence as renewed is intended to relate;

(d) particulars of the equipment which is or will be available for storing medicinal products on those premises;

(e) particulars of the equipment and facilities which are or will be available for distributing medicinal products from those premises; and

(f) particulars of arrangements made or to be made for securing the safekeeping and maintenance of adequate records in respect of medicinal products to be stored or distributed from those premises.”.