Part II Licences and Certificates Relating to Medicinal Products
General provisions and exemptions
F16 The licensing authority.
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F17 General provisions as to dealing with medicinal products.
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F18 Provisions as to manufacture and wholesale dealing.
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F1 9 Exemptions for doctors and dentists
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10 Exemptions for pharmacists.
(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 F8..., 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.
F9(2)
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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, F10 ...
F10(b)
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(4)
Without prejudice to the preceding subsections, the restrictions imposed by F11regulations 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 F12provided 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 F13or from that registered pharmacy or at F13or 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.
F14(5)
Without prejudice to the preceding subsections, the restrictions imposed by F15 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 F16or 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 F18or from that registered pharmacy.
F19(6A)
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F20(7)
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F21(7A)
The F22 ... 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 F23regulation 7 (advertisements relating to medicinal products) of the 2012 Regulations.
F24(9)
In subsection (1) of this section, “care home service" has the meaning given by F25paragraph 2 of schedule 12 to the Public Services Reform (Scotland) Act 2010 (asp 8) .
F2611 Exemption for nurses and midwives.
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F2612 Exemptions in respect of herbal remedies.
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F2613 Exemptions for imports.
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F26 14 Exemption for re-exports.
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15 Provision for extending or modifying exemptions.
F27(1)
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F27(2)
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(3)
(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.
F3016 Transitional exemptions.
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F3017 Termination of transitional exemptions.
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Applications for, and grant and renewal of, licences
F3018 Application for licence.
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F3019 Factors relevant to determination of application for licence.
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F3020 Grant or refusal of licence.
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F30 21 Procedure on reference to appropriate committee
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F30 22 Procedure in other cases.
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F30 22A. Hearing before person appointed
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F3023 Special provisions as to effect of manufacturer’s licence.
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F3024 Duration and renewal of licence.
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Licences of right
F3025 Entitlement to licence of right.
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F3126 Scope of licence of right in different cases.
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F3027 Proceedings on application for licence of right.
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Suspension, revocation and variation of licences
F3028 General power to suspend, revoke or vary licences.
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F3029 Procedure where licensing authority propose to suspend, revoke or vary licence under s. 28.
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F3030 Variation of licence on application of holder.
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Clinical trials and medicinal tests on animals
F3231 Clinical trials.
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F3332 Medicinal tests on animals.
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F3333 Exemptions in respect of medicinal tests on animals.
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F3334 Restrictions as to animals on which medicinal tests have been carried out.
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F3335 Supplementary provisions as to clinical trials and medicinal tests on animals.
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F3336 Application for, and issue of, certificate.
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F3437 Transitional provisions as to clinical trials and medicinal tests on animals.
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F3538 Duration and renewal of certificate.
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F3539 Suspension, revocation or variation of certificate.
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Medicated animal feeding stuffs
F3540 Medicated animal feeding stuffs.
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41–42. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . F36
Supplementary provisions
F3043 Extension of s. 7 to certain special circumstances.
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F3044 Provision of information to licensing authority.
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F3045 Offences under Part II.
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F3046 Special defences under s. 45.
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F3047 Standard provisions for licences
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F3048 Postponement of restrictions in relation to exports.
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F3049 Special provisions in respect of exporting certain products.
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F37 49A Special provisions in respect of exporting certain products to member States
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F3049B. Special provisions in respect of exporting certain products to EEA State s
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F3050 Certificates for exporters of medicinal products.
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