Part II Licences and Certificates Relating to Medicinal Products
General provisions and exemptions
F216 The licensing authority.
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F217 General provisions as to dealing with medicinal products.
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F218 Provisions as to manufacture and wholesale dealing.
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F21 9 Exemptions for doctors and dentists
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C2 10 Exemptions for pharmacists. C1
1
F14 ... the restrictions imposed by F25regulations 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 F24an 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 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 that registered pharmacy or at 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.
F15 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, F16 ...
F16 b
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4
Without prejudice to the preceding subsections, the restrictions imposed by F26 regulations 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 that registered pharmacy or at 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 F27 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 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 F28 regulation 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 that registered pharmacy.
F17 6A
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F29 7
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F117A
The F18 ... 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
F59
In subsection (1) of this section, “care home service" has the meaning given by F20 paragraph 2 of schedule 12 to the Public Services Reform (Scotland) Act 2010 (asp 8) .
F2211 Exemption for nurses and midwives.
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F2212 Exemptions in respect of herbal remedies.
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F2213 Exemptions for imports.
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F22 14 Exemption for re-exports.
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15 Provision for extending or modifying exemptions. C3
F311
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F312
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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.
F2316 Transitional exemptions.
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F2317 Termination of transitional exemptions.
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Applications for, and grant and renewal of, licences
F2318 Application for licence.
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F2319 Factors relevant to determination of application for licence.
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F2320 Grant or refusal of licence.
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F23 21 Procedure on reference to appropriate committee
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F23 22 Procedure in other cases.
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F23 22A Hearing before person appointed
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F2323 Special provisions as to effect of manufacturer’s licence.
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F2324 Duration and renewal of licence.
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Licences of right
F2325 Entitlement to licence of right.
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F826 Scope of licence of right in different cases.
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F2327 Proceedings on application for licence of right.
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Suspension, revocation and variation of licences
F2328 General power to suspend, revoke or vary licences.
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F2329 Procedure where licensing authority propose to suspend, revoke or vary licence under s. 28.
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F2330 Variation of licence on application of holder.
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Clinical trials and medicinal tests on animals
F731 Clinical trials.
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F1232 Medicinal tests on animals.
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F1233 Exemptions in respect of medicinal tests on animals.
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F1234 Restrictions as to animals on which medicinal tests have been carried out.
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F1235 Supplementary provisions as to clinical trials and medicinal tests on animals.
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F1236 Application for, and issue of, certificate.
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F937 Transitional provisions as to clinical trials and medicinal tests on animals.
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F1338 Duration and renewal of certificate.
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F1339 Suspension, revocation or variation of certificate.
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Medicated animal feeding stuffs
F1340 Medicated animal feeding stuffs.
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41–42. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . F6
Supplementary provisions
F2343 Extension of s. 7 to certain special circumstances.
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F2344 Provision of information to licensing authority.
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F2345 Offences under Part II.
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F2346 Special defences under s. 45.
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F2347 Standard provisions for licences
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F2348 Postponement of restrictions in relation to exports.
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F2349 Special provisions in respect of exporting certain products.
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F10 49A Special provisions in respect of exporting certain products to member States
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F2349B Special provisions in respect of exporting certain products to EEA State s
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F2350 Certificates for exporters of medicinal products.
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