PART 12U.K.Dealings with medicinal products

Modifications etc. (not altering text)

CHAPTER 3U.K.Exemptions

Other exemptionsU.K.

Exemption in cases involving another's defaultU.K.

244.—(1) Regulation 214(1) does not apply to the sale or supply of a prescription only medicine by a person if the person, having exercised all due diligence, believes on reasonable grounds that the product is not a prescription only medicine.

(2) Regulation 220 does not apply to the sale or supply, or offer for sale or supply of a medicinal product by a person if—

(a)the person, having exercised all due diligence, believes on reasonable grounds that the product is subject to general sale;

(b)that belief is due to the act or default of another person; and

(c)the conditions in regulation 221 are met in relation to the sale or supply, or offer for sale or supply of the product.

Exemption in case of forged prescriptionU.K.

245.  Regulation 214(1) does not apply to the sale or supply of a prescription only medicine by a pharmacist in accordance with a forged prescription if the pharmacist, having exercised all due diligence, believes on reasonable grounds that the prescription is genuine.

Exemption where requirements for prescriptions not metU.K.

246.  Regulation 214(1) does not apply to the sale or supply of a prescription only medicine otherwise than in accordance with a prescription given by an appropriate practitioner if—

(a)the sale or supply is otherwise than in accordance with such a prescription because a condition in regulation 217, 218[F1, 219 or 219A] is not met; and

(b)the person selling or supplying the prescription only medicine, having exercised all due diligence, believes on reasonable grounds that the condition is met.

Textual Amendments

F1Words in reg. 246(a) substituted (E.W.S.) (1.7.2015) by The Human Medicines (Amendment) (No. 2) Regulations 2015 (S.I. 2015/903), regs. 1, 6 and words in reg. 246(a) substituted (N.I.) (1.7.2015) by The Human Medicines (Amendment) (No. 2) Regulations 2015 (S.R. 2015/259), regs. 1, 6

Exemption for supply in the event or anticipation of pandemic diseaseU.K.

247.—(1) Regulations 214(1), 220 and 221 do not apply to the supply of a medicinal product that meets the following conditions.

(2) Condition A is that the supply is made whilst a disease is, or in anticipation of a disease being imminently—

(a)pandemic; and

(b)a serious risk, or potentially a serious risk, to human health.

(3) Condition B is that the supply is accordance with a protocol that—

(a)is approved by the Ministers [F2or an NHS body];

(b)specifies [F3how the medicinal product is to be used for the prevention of or as a] treatment for the disease; and

(c)contains requirements as to the recording of—

(i)the name of the person who supplies the product to the person to be treated (“the patient”) or to a person acting on the patient's behalf, and

(ii)evidence that the product was supplied to the patient or to a person acting on the patient's behalf.

[F4(4) A function of the Ministers under this regulation may be exercised by either of them acting alone or both of them acting jointly (and the reference in this regulation to “the Ministers” is to be read accordingly).]

Textual Amendments

[F5Protocols relating to coronavirus and influenza vaccinations and immunisationsU.K.

247A.—(1) Regulations 214, 220 and 221 do not apply to the supply or administration of a medicinal product used for vaccination or immunisation against coronavirus or influenza virus (of any type) that meets the following conditions.

F6(2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(3) Condition B is that the supply or administration is in accordance with the requirements of a protocol that is approved by the Secretary of State, the Scottish Ministers, the Welsh Ministers or the Minister of Health in Northern Ireland.

(4) Condition C is that the protocol specifies (amongst other matters)—

(a)the classes of persons permitted to administer medicinal products under the protocol;

(b)the process by which a person of the specified class is designated, and by whom, as a person authorised to administer medicinal products under the protocol;

(c)requirements as to the recording of the name of a person who, on any particular occasion, administers a medicinal product under the protocol; and

(d)requirements, where appropriate, for the supervision of a person who, on any particular occasion, administers a medicinal product under the protocol.

(5) Condition D is that when the medicine is supplied, there is in force in relation to it—

(a)an authorisation by the licensing authority on a temporary basis under regulation 174;

(b)before 1st January 2021, a marketing authorisation; or

(c)on and after 1st January 2021, a UK marketing authorisation [F7(including in Northern Ireland if supply is in accordance with regulation 167A)] or, in Northern Ireland, an EU marketing authorisation.]

F8(6) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

[F9(7) This regulation ceases to have effect on 1st April 2026.]

Textual Amendments

Exemption for certain collection and delivery arrangementsU.K.

248.—(1) Regulations 220 and 221 do not apply to the supply of a medicinal product on premises that are not a registered pharmacy where the supply—

(a)is in accordance with a prescription issued by a doctor, dentist, nurse independent prescriber, pharmacist independent prescriber[F10, physiotherapist independent prescriber, podiatrist independent prescriber, therapeutic radiographer independent prescriber][F11, paramedic independent prescriber] or optometrist independent prescriber; and

(b)forms part of a collection and delivery arrangement used by a person who lawfully conducts a retail pharmacy business.

(2) In this regulation “collection and delivery arrangement” means an arrangement whereby a person may—

(a)take or send a prescription given by a doctor, dentist, nurse independent prescriber, pharmacist independent prescriber[F12, physiotherapist independent prescriber, podiatrist independent prescriber, therapeutic radiographer independent prescriber][F13, paramedic independent prescriber] or optometrist independent prescriber to premises other than a registered pharmacy and which are capable of being closed by the occupier to exclude the public; and

(b)collect or have collected on his or her behalf from such premises a medicinal product prepared or dispensed in accordance with such a prescription at a registered pharmacy by or under the supervision of a pharmacist.

Textual Amendments

F10Words in reg. 248(1)(a) inserted (E.W.S.) (1.4.2016) by The Human Medicines (Amendment) Regulations 2016 (S.I. 2016/186), regs. 1, 12(2) and words in reg. 248(1)(a) inserted (N.I.) (1.4.2016) by The Human Medicines (Amendment) Regulations 2016 (S.R. 2016/407), regs. 1, 12(2)

F11Words in reg. 248(1)(a) inserted (1.4.2018) by The Human Medicines (Amendment) Regulations 2018 (S.I. 2018/199), regs. 1, 10(2) and words in reg. 248(1)(a) inserted (N.I.) (1.4.2018) by The Human Medicines (Amendment) Regulations 2018 (S.R. 2018/64), regs. 1, 10(2)

F12Words in reg. 248(2)(a) inserted (E.W.S.) (1.4.2016) by The Human Medicines (Amendment) Regulations 2016 (S.I. 2016/186), regs. 1, 12(3) and words in reg. 248(2)(a) inserted (N.I.) (1.4.2016) by The Human Medicines (Amendment) Regulations 2016 (S.R. 2016/407), regs. 1, 12(3)

F13Words in reg. 248(2)(a) inserted (1.4.2018) by The Human Medicines (Amendment) Regulations 2018 (S.I. 2018/199), regs. 1, 10(3) and words in reg. 248(2)(a) inserted (N.I.) (1.4.2018) by The Human Medicines (Amendment) Regulations 2018 (S.R. 2018/64), regs. 1, 10(3)