The Human Medicines (Amendment) Regulations 2019

Insertion of regulation 226A (sale etc by a pharmacist in accordance with a serious shortage protocol)

9.  After regulation 226 (emergency sale etc by pharmacists: pandemic disease), insert—

“Sale etc by a pharmacist in accordance with a serious shortage protocol

226A.— (1) Regulation 214(1) does not apply to the sale or supply of a prescription only medicine by a person lawfully conducting a retail pharmacy business if conditions A, B and C are met.

(2) Condition A is that the prescription only medicine is sold or supplied for the purpose of being administered to a person in accordance with a serious shortage protocol (SSP).

(3) Condition B is that the requirements of the SSP are satisfied in respect of to whom, and subject to what conditions, the prescription only medicine may be sold or supplied for the purpose of being administered.

(4) Condition C is that the sale or supply of the prescription only medicine is by or under the supervision of a pharmacist who is of the opinion, in the exercise of his or her professional skill and judgement, that—

(a) in a case to which paragraph (5)(b)(i) applies, the sale or supply of a different strength, quantity or pharmaceutical form of the prescription only medicine to the strength, quantity or pharmaceutical form of the prescription only medicine ordered by the prescriber is reasonable and appropriate; or

(b) in a case to which paragraph (5)(b)(ii) applies, the sale or supply of—

(i) a prescription only medicine other than the prescription only medicine ordered by the prescriber is reasonable, and

(ii) the substituted prescription only medicine, in accordance with the directions for use that he or she specifies, is appropriate.

(5) For the purposes of this regulation, a SSP is a written protocol that—

(a) is issued by the Ministers (either of them acting alone or both of them acting jointly) in circumstances where the United Kingdom or any part of the United Kingdom is, in the opinion of the Ministers (either of them forming the opinion alone or both of them forming the opinion jointly), experiencing or may experience a serious shortage of a prescription only medicine or prescription only medicines of a specified description;

(b) provides for the sale or supply by or under the supervision of a pharmacist and subject to such conditions as may be specified in the SSP—

(i) of a different strength, quantity or pharmaceutical form of the prescription only medicine to the strength, quantity or pharmaceutical form ordered by the prescriber, or

(ii) of a prescription only medicine other than the prescription only medicine ordered by the prescriber;

(c) provides, in a case to which sub-paragraph (b)(ii) applies, that the other prescription only medicine is to be—

(i) a generic version of the prescription only medicine being substituted, or that both products are generic versions of another prescription only medicine,

(ii) in the case of a biological medicinal product, a similar medicinal product to the prescription only medicine being substituted, or that both products are similar medicinal products to another biological medicinal product, or

(iii) a prescription only medicine that has a similar therapeutic effect to the prescription only medicine being substituted; and

(d) specifies the period for which, and the parts of the United Kingdom (which may be all of the United Kingdom) in which, the protocol is to have effect.

(6) As soon as is reasonably practical after the end of one year beginning on the day on which the first protocol issued under this regulation has effect, the Ministers must—

(a) review the operation of this regulation with a view to evaluating whether there have been any adverse consequences for the market in prescription only medicines or for patient safety as a consequence of the operation of this regulation;

(b) set out the conclusions of the review in a report; and

(c) publish the report.”.