Article 5 Exemption from the requirement for manufacturer’s licence or marketing authorisation: registered pharmacy technicians at hospital aseptic facilities

After regulation 4 of the Human Medicines Regulations 2012^f1 (special provisions for pharmacies etc.) insert—

“Special provisions for registered pharmacy technicians at hospital aseptic facilities

4A.

(1)

The prohibitions in regulations 17(1) (manufacturing of medicinal products: requirement for licence) and 46 (requirement for authorisation) do not apply to anything which is done in Great Britain in a hospital aseptic facility in the course of the provision of a relevant pharmacy service if—

(a)

it is done as part of a clinical process;

(b)

it is done by or under the supervision of a registered pharmacy technician;

(c)

in the case of anything done to a medicinal product prior to the retail sale of the medicinal product or the supply of that product in circumstances corresponding to retail sale, what is done consists of—

(i)

preparing or dispensing a medicinal product in pursuance of a prescription for a magistral formula product or an officinal formula product, or

(ii)

preparing, assembling or dispensing a medicinal product that has already been lawfully placed on the market in the United Kingdom, or the component medicinal products or medical devices of which have already been so placed,

and is with a view to the retail sale of the medicinal product or the supply of that medicinal product in circumstances corresponding to retail sale;

(d)

in a case where sub-paragraph (c)(ii) applies, the composition of the medicinal product is not modified by, nor are its components modified by, the preparation, assembly or dispensing in such a way or to the extent that it is appropriate to treat—

(i)

the retail sale of that medicinal product, or

(ii)

the supply of that medicinal product in circumstances corresponding to retail sale,

as an occasion on which a new medicinal product is placed on the market in the United Kingdom; and

(e)

in the case of the dispensing of a medicinal product in pursuance of a prescription or direction given by an appropriate practitioner, the dispensing is in accordance with that prescription or direction.

(2)

Chapter 1 of Part 13 (requirements for packaging and package leaflets relating to medicinal products) does not apply to a medicinal product that, as the result of a process of preparation or assembly that is in accordance with paragraph (1), is no longer supplied in accordance with the terms of any authorisation or registration in force for the product of a type mentioned in regulation 3(15), but only if the medicinal product has been labelled with—

(a)

the name of the patient for whom it has been ordered; and

(b)

such other information as the person preparing or assembling the medicinal product considers it appropriate to add to the label.

(3)

For the purposes of paragraph (1)—

(a)

a pharmacy service is a “relevant pharmacy service” if conditions A and B in section 67F of the Medicines Act 1968 (sections 67A to 67D: “relevant pharmacy service”) are met in respect of it; and

(b)

a medicinal product (including a component medicinal product) has been lawfully placed on the market in the United Kingdom if—

(i)

there is an authorisation or a registration in force for the product of the type mentioned in regulation 3(15), or

(ii)

there is no such authorisation or registration in force but it has been supplied to the hospital aseptic facility in accordance with Part 10 (exceptions to requirement for marketing authorisation) or as an investigational medicinal product in accordance with the Clinical Trials Regulations.”.