Part IIU.K. Licences and Certificates Relating to Medicinal Products

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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Applications for, and grant and renewal of, licencesU.K.

F2918 Application for licence. U.K.

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F2919 Factors relevant to determination of application for licence. U.K.

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F2920 Grant or refusal of licence. U.K.

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F29 21 Procedure on reference to appropriate committee U.K.

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F29 22 Procedure in other cases. U.K.

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F29 22A .Hearing before person appointedU.K.

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F2923 Special provisions as to effect of manufacturer’s licence. U.K.

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F2924 Duration and renewal of licence. U.K.

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Licences of rightU.K.

F2925 Entitlement to licence of right. U.K.

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F3026 Scope of licence of right in different cases. U.K.

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F2927 Proceedings on application for licence of right. U.K.

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Suspension, revocation and variation of licencesU.K.

F2928 General power to suspend, revoke or vary licences. U.K.

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F2929 Procedure where licensing authority propose to suspend, revoke or vary licence under s. 28.U.K.

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F2930 Variation of licence on application of holder. U.K.

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Clinical trials and medicinal tests on animalsU.K.

F3131 Clinical trials. U.K.

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F3232 Medicinal tests on animals. U.K.

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F3233 Exemptions in respect of medicinal tests on animals. U.K.

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F3234 Restrictions as to animals on which medicinal tests have been carried out. U.K.

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F3235 Supplementary provisions as to clinical trials and medicinal tests on animals.U.K.

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F3236 Application for, and issue of, certificate. U.K.

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F3337 Transitional provisions as to clinical trials and medicinal tests on animals. U.K.

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F3438 Duration and renewal of certificate. U.K.

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F3439 Suspension, revocation or variation of certificate. U.K.

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Medicated animal feeding stuffsU.K.

F3440 Medicated animal feeding stuffs. U.K.

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41–42. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . F35U.K.

Supplementary provisionsU.K.

F2943 Extension of s. 7 to certain special circumstances. U.K.

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F2944 Provision of information to licensing authority. U.K.

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F2945 Offences under Part II. U.K.

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F2946 Special defences under s. 45. U.K.

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F2947 Standard provisions for licences U.K.

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F2948 Postponement of restrictions in relation to exports. U.K.

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F2949 Special provisions in respect of exporting certain products. U.K.

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F36 49A Special provisions in respect of exporting certain products to member States U.K.

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F2949B. Special provisions in respect of exporting certain products to EEA State s U.K.

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F2950 Certificates for exporters of medicinal products. U.K.

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