Regulation 44 Requirement for wholesale dealers to deal only with specified personsF1

the holder of a manufacturer’s licence or wholesale dealer’s licence in relation to products of that description;

the person who holds an authorisation granted by F4an approved country for import (in the case of a licence holder in Great Britain) or by an EEA State (in the case of a licence holder in Northern Ireland) authorising the manufacture of products of the description or their distribution by way of wholesale dealing; F5or

where the medicinal product is directly received—

the supplier of the medicinal product in country A is a person who is authorised or entitled to supply such medicinal products in accordance with the legal and administrative provisions in country A.

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

the wholesale dealer who supplies the product complies with the principles and guidelines of good distribution practices; or

the manufacturer or importer who supplies the product holds a manufacturing authorisation.

the holder of a wholesale dealer’s licence relating to those products;

the holder of an authorisation granted by—

that is responsible for authorising the supply of those products by way of wholesale dealing;

a person who may lawfully sell those products by retail or may lawfully supply them in circumstances corresponding to retail sale;

a person who may lawfully administer those products; or

in relation to supply—

date on which the supply took place;

name and pharmaceutical form of the product supplied;

quantity of product supplied; F14and

name and address of the licence holderF15.

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

keep a record of information supplied in accordance with paragraph (6) for at least five years beginning immediately after the date on which the information is supplied; and

ensure that the record is available to the licensing authority for inspection.

in the case of a licence holder in Great Britain, products received from Northern Ireland, and

in the case of a licence holder in Northern Ireland, products received from Great Britain.

in the case of a licence holder in Great Britain, products supplied to Northern Ireland, and

in the case of a licence holder in Northern Ireland, products supplied to Great Britain.