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Part 3 · Supply of Therapeutic Products

18. Requirements for issue of wholesaler’s licence

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For the purposes of section 24(2)(a)(i) of the Act, the requirements that must be satisfied for the issue, to an applicant, of a wholesaler’s licence for a therapeutic product are that —

(a)

the applicant is able to provide and maintain, or ensure the provision and maintenance of, such staff, premises, equipment and facilities for the handling, storage and distribution of the therapeutic product as are necessary to prevent the deterioration of the therapeutic product while it is in the applicant’s ownership, possession or control; and

(b)

the applicant is able to comply with the Authority’s Guidance Notes on Good Distribution Practice for wholesalers set out on the Authority’s website.

Report

Part 4

Presentation of Therapeutic Products

Part 5

Registration of Therapeutic Products

Part 6

Duties and Obligations of Manufacturers, Importers, Etc., of Therapeutic Products

Part 7

Exceptions — Manufacture, Import and Wholesale of Therapeutic Products Without Licence

Part 8

Exceptions — Supply of Therapeutic Products Without Registration

Part 8A

Exception — Emergency Therapeutic Products

Part 9

Miscellaneous

Schedules