Regulation 4 New regulation 10A

After regulation 10 (possession of drugs in Schedules 2, 3 and 4) insert—

“Directions of a practitioner while a disease is, or in anticipation of a disease being imminently, pandemic etc.

10A.

(1)

For the purposes of regulation 10(2), the directions of a practitioner may be the directions of a pharmacist, which do not require a prescription, in the following circumstances—

(a)

as a consequence of a disease being, or in anticipation of a disease being imminently—

(i)

pandemic, and

(ii)

a serious risk or potentially a serious risk to human health,

in order to assist in the management of the serious risk or potentially serious risk to human health, the Department has made an announcement in respect of the supply of drugs specified in Schedule 2, 3 or Part 1 of Schedule 4 as part of the health service;

(b)

as part of the announcement, the Department has issued advice to the effect that—

(i)

in the area to which the announcement relates,

(ii)

in the particular circumstances specified in the announcement, and

(iii)

during the period specified in the announcement,

arrangements for the provision of services as part of the health service (“health service arrangements”) with a person lawfully conducting a retail pharmacy business may include provisions permitting the supply of drugs specified in Schedule 2, 3 or Part 1 of Schedule 4 in accordance with the directions of a pharmacist, provided that the supply is in accordance with regulation 226 or 226A of the Human Medicines Regulations 2012^f1;

(c)

the person lawfully conducting a retail pharmacy business with whom the health service arrangements are made complies with the requirements of the arrangements in respect of the supply of drugs specified in Schedule 2, 3 or Part 1 of Schedule 4; and

(d)

the period specified in the announcement (taking into account any extension) has not ended and the announcement has not been withdrawn or amended in a way that means that the relevant provisions in the health service arrangements are no longer permitted by the announcement.

(2)

The period specified in the announcement, as mentioned in paragraph (1)(b)(iii), must initially not be for more than three months, but it may be extended for further periods of not more than three months at a time.”.