PART 6Information about price and availability of health service medicines

Provision of information about availability of health service medicines28

1

This regulation applies where the Secretary of State considers that there is a supply shortage of a presentation of health service medicine (the “relevant presentation”).

2

Where this regulation applies, the Secretary of State may by notice in writing require any of the following to provide the information mentioned in paragraph (3) about the relevant presentation—

a

a manufacturer of the presentation,

b

a person who distributes the presentation (whether by wholesale dealing or otherwise), or

c

an importer of the presentation.

3

The information is—

a

the quantity (if any) of packs of the relevant presentation that is available for supply by the producer, and

b

the quantity (if any) of any alternative presentation specified in the request that is available for supply by the producer.

4

A producer who is given a notice under paragraph (2) must comply with the request within the period of two working days beginning—

a

with the day on which producer is given the request, if that day is a working day;

b

otherwise, with the first working day after the day on which the notice is given to the producer.

5

In this regulation, “alternative presentation”, in relation to a relevant presentation, means a presentation of health service medicine which is used as a therapeutic alternative to the relevant presentation.