The licensing authority.
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Medicines Act 1968 Part II — Licences and Certificates Relating to Medicinal Products
General provisions and exemptions
General provisions as to dealing with medicinal products.
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Provisions as to manufacture and wholesale dealing.
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Exemptions for doctors and dentists
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Exemptions for pharmacists.
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(1) ... The restrictions imposed by 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, a hospital , 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 an appropriate practitioner , or (b) assembling a medicinal product provided that where the assembling takes place in a registered pharmacy— (i) it shall be in a registered pharmacy at or 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 or from that registered pharmacy or at or from any other such registered pharmacy ... , 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. (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, ... (b) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (4) Without prejudice to the preceding subsections, the restrictions imposed by 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 provided 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 or from that registered pharmacy or at or 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. (5) Without prejudice to the preceding subsections, the restrictions imposed by 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 or 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 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 or from that registered pharmacy. (6A) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (7) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (7A) The ... 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 regulation 7 (advertisements relating to medicinal products) of the 2012 Regulations . (9) In subsection (1) of this section, “care home service" has the meaning given by paragraph 2 of schedule 12 to the Public Services Reform (Scotland) Act 2010 (asp 8) .
Exemption for nurses and midwives.
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Exemptions in respect of herbal remedies.
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Exemptions for imports.
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Exemption for re-exports.
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Provision for extending or modifying exemptions.
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(1) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (3) The ... Ministers may by order provide that any of the provisions of 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.
Transitional exemptions.
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Termination of transitional exemptions.
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Applications for, and grant and renewal of, licences
Application for licence.
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Factors relevant to determination of application for licence.
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Grant or refusal of licence.
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Procedure on reference to appropriate committee
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Procedure in other cases.
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Hearing before person appointed
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Special provisions as to effect of manufacturer’s licence.
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Duration and renewal of licence.
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Licences of right
Entitlement to licence of right.
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Scope of licence of right in different cases.
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Proceedings on application for licence of right.
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Suspension, revocation and variation of licences
General power to suspend, revoke or vary licences.
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Procedure where licensing authority propose to suspend, revoke or vary licence under s. 28.
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Variation of licence on application of holder.
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Clinical trials and medicinal tests on animals
Clinical trials.
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Medicinal tests on animals.
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Exemptions in respect of medicinal tests on animals.
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Restrictions as to animals on which medicinal tests have been carried out.
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Supplementary provisions as to clinical trials and medicinal tests on animals.
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Application for, and issue of, certificate.
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Transitional provisions as to clinical trials and medicinal tests on animals.
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Duration and renewal of certificate.
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Suspension, revocation or variation of certificate.
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Medicated animal feeding stuffs
Medicated animal feeding stuffs.
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Supplementary provisions
Extension of s. 7 to certain special circumstances.
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Provision of information to licensing authority.
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Offences under Part II.
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Special defences under s. 45.
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Standard provisions for licences
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Postponement of restrictions in relation to exports.
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Special provisions in respect of exporting certain products.
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Special provisions in respect of exporting certain products to member States
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Special provisions in respect of exporting certain products to EEA State s
49B
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Certificates for exporters of medicinal products.
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Back to Medicines Act 1968 — full text
Provisions on this page are reproduced verbatim from official open data. See the attribution line.
Contains public sector information licensed under the Open Government Licence v3.0 (legislation.gov.uk).