Part II Licences and Certificates Relating to Medicinal Products

General provisions and exemptions

C2 10 Exemptions for pharmacists. C1

1

F7 ... The restrictions imposed by F14regulations 17(1) (manufacturing of medicinal products) and 46 (requirement for authorisation) of the 2012 Regulations do not apply to anything which is done in a registered pharmacy, a hospital F1, a care home service or a health centre and is done there by or under the supervision of a pharmacist and consists of—

a

preparing or dispensing a medicinal product in accordance with a prescription given by F13an appropriate practitioner, or

b

assembling a medicinal product F2provided that where the assembling takes place in a registered pharmacy—

i

it shall be in a registered pharmacy at F20or from which the business in medicinal products carried on is restricted to retail sale or to supply in circumstances corresponding to retail sale and the assembling is done with a view to such sale or supply either at F20or from that registered pharmacy or at F20or from any other such registered pharmacy forming part of the same retail pharmacy business, and

ii

the medicinal product has not been the subject of an advertisement; and those restrictions do not apply to anything done by or under the supervision of a pharmacist which consists of procuring the preparation or dispensing of a medicinal product in accordance with a prescription given by a practitioner, or of procuring the assembly of a medicinal product.

F82

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3

Those restrictions do not apply to the preparation or dispensing in a registered pharmacy of a medicinal product by or under the supervision of a pharmacist in accordance with a specification furnished by the person to whom the product is or is to be sold or supplied, where—

a

the product is prepared or dispensed for administration to that person or to a person under his care, F9 ...

F9b

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4

Without prejudice to the preceding subsections, the restrictions imposed by F15regulations 17(1) (manufacturing of medicinal products) and 46 (requirement for authorisation) of the 2012 Regulations do not apply to anything which is done in a registered pharmacy by or under the supervision of a pharmacist and consists of—

a

preparing or dispensing a medicinal product for administration to a person where the pharmacist is requested by or on behalf of that person to do so in accordance with the pharmacist’s own judgment as to the treatment required, and that person is present in the pharmacy at the time of the request in pursuance of which that product is prepared or dispensed, or

b

preparing a stock of medicinal products with a view to dispensing them as mentioned in subsection (1)(a) or subsection (3) of this section or in paragraph (a) of this subsection F3provided that such stock is prepared with a view to retail sale or to supply in circumstances corresponding to retail sale and the preparation is done with a view to such sale or supply either at F21or from that registered pharmacy or at F21or from any other registered pharmacy forming part of the same retail pharmacy business;

and those restrictions do not apply to anything which is done in a hospital or a health centre by or under the supervision of a pharmacist and consists of preparing a stock of medicinal products with a view to dispensing them as mentioned in subsection (1)(a) of this section.

F45

Without prejudice to the preceding subsections, the restrictions imposed by F16 regulation 46 of the 2012 Regulations do not apply to the preparation or dispensing in a registered pharmacy of a medicinal product by or under the supervision of a pharmacist where—

a

the medicinal product is prepared or dispensed otherwise than in pursuance of an order from any other person, and

b

the medicinal product is prepared with a view to retail sale or supply in circumstances corresponding to retail sale at F22or from the registered pharmacy at which it is prepared, and

c

the medicinal product has not been the subject of an advertisement.

6

Without prejudice to the preceding subsections, the restrictions imposed by F17regulation 17(1) of the 2012 Regulations do not apply to anything which is done in a registered pharmacy by or under the supervision of a pharmacist and consists of preparing a medicinal product with a view to retail sale or to supply in circumstances corresponding to retail sale at F23or from that registered pharmacy.

F106A

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F187

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F67A

The F11 ... Ministers may make regulations prescribing conditions which must be complied with if a thing is to be considered for the purposes of this section as done under the supervision of a pharmacist.

7B

Conditions prescribed under subsection (7A) may relate to supervision in the case where the pharmacist is not at the place where the thing is being done, and in that case the thing is not to be so considered if no such conditions are prescribed.

7C

In any case, compliance with any applicable conditions is sufficient for the thing to be so considered.

8

For the purposes of this section “advertisement" shall have the meaning assigned to it by F19regulation 7 (advertisements relating to medicinal products) of the 2012 Regulations.

F59

In subsection (1) of this section, “care home service" has the meaning given by F12paragraph 2 of schedule 12 to the Public Services Reform (Scotland) Act 2010 (asp 8) .