Medicines Act 1968

General provisions and exemptionsU.K.

F16 The licensing authority. U.K.

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F17 General provisions as to dealing with medicinal products. U.K.

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F18 Provisions as to manufacture and wholesale dealing. U.K.

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F1 9 Exemptions for doctors and dentists U.K.

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10 Exemptions for pharmacists. U.K.

(1)F2 ... The restrictions imposed by [F3regulations 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 [F4, 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 [F5an appropriate practitioner], or

(b)assembling a medicinal product [F6provided that where the assembling takes place in a registered pharmacy—

(i)it shall be in a registered pharmacy at [F7or 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 [F7or from] that registered pharmacy or at [F7or 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.

F8(2). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(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 ...

F9(b). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(4)Without prejudice to the preceding subsections, the restrictions imposed by [F10regulations 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 [F11provided 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 [F12or from] that registered pharmacy or at [F12or 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.

[F13(5)Without prejudice to the preceding subsections, the restrictions imposed by [F14 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 [F15or 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 [F16regulation 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 [F17or from] that registered pharmacy.

F18(6A). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F19(7). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

[F20(7A)The F21 ... 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 [F22regulation 7 (advertisements relating to medicinal products) of the 2012 Regulations].]

[F23(9)In subsection (1) of this section, “care home service" has the meaning given by [F24paragraph 2 of schedule 12 to the Public Services Reform (Scotland) Act 2010 (asp 8) ]. ]

F2511 Exemption for nurses and midwives. U.K.

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F2512 Exemptions in respect of herbal remedies. U.K.

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F2513 Exemptions for imports. U.K.

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F25 14 Exemption for re-exports. U.K.

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15 Provision for extending or modifying exemptions. U.K.

F26(1). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F26(2). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(3) The F27 ... Ministers may by order provide that any of the provisions of [F28 section 10 ] of this Act specified in the order shall cease to have effect, or shall have effect subject to such exceptions or modifications as may be so specified.

(4)No order shall be made under subsection (3) of this section unless a draft of the order has been laid before Parliament and approved by a resolution of each House of Parliament.

F2916 Transitional exemptions. U.K.

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F2917 Termination of transitional exemptions. U.K.

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