Medicines Act 1968

• Citation: 1968 c. 67
• Sections: 243

Section 1 Ministers responsible for administration of Act.

In this Act, “the Ministers” has the meaning given by regulation 6(6) to (8) of the 2012 Regulations (but as if references in that regulation to those Regulations were references to this Act).

Section 2 Establishment of Medicines Commission.

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Section 2A Establishment of the Commission on Human Medicines

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Section 3 Functions of the Commission

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Section 4 Establishment of committees.

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Section 5 Supplementary provisions as to Commission and committees.

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Section 6 The licensing authority.

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Section 7 General provisions as to dealing with medicinal products.

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Section 8 Provisions as to manufacture and wholesale dealing.

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Section 9 Exemptions for doctors and dentists

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Section 10 Exemptions for pharmacists.

(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.

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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, ...

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(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.

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(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) .

Section 11 Exemption for nurses and midwives.

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Section 12 Exemptions in respect of herbal remedies.

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Section 13 Exemptions for imports.

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Section 14 Exemption for re-exports.

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Section 15 Provision for extending or modifying exemptions.

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(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.

Section 16 Transitional exemptions.

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Section 17 Termination of transitional exemptions.

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Section 18 Application for licence.

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Section 19 Factors relevant to determination of application for licence.

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Section 20 Grant or refusal of licence.

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Section 21 Procedure on reference to appropriate committee

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Section 22 Procedure in other cases.

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Section 22A Hearing before person appointed

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Section 23 Special provisions as to effect of manufacturer’s licence.

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Section 24 Duration and renewal of licence.

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Section 25 Entitlement to licence of right.

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Section 26 Scope of licence of right in different cases.

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Section 27 Proceedings on application for licence of right.

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Section 28 General power to suspend, revoke or vary licences.

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Section 29 Procedure where licensing authority propose to suspend, revoke or vary licence under s. 28.

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Section 30 Variation of licence on application of holder.

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Section 31 Clinical trials.

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Section 32 Medicinal tests on animals.

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Section 33 Exemptions in respect of medicinal tests on animals.

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Section 34 Restrictions as to animals on which medicinal tests have been carried out.

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Section 35 Supplementary provisions as to clinical trials and medicinal tests on animals.

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Section 36 Application for, and issue of, certificate.

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Section 37 Transitional provisions as to clinical trials and medicinal tests on animals.

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Section 38 Duration and renewal of certificate.

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Section 39 Suspension, revocation or variation of certificate.

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Section 40 Medicated animal feeding stuffs.

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Section 43 Extension of s. 7 to certain special circumstances.

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Section 44 Provision of information to licensing authority.

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Section 45 Offences under Part II.

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Section 46 Special defences under s. 45.

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Section 47 Standard provisions for licences

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Section 48 Postponement of restrictions in relation to exports.

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Section 49 Special provisions in respect of exporting certain products.

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Section 49A Special provisions in respect of exporting certain products to member States

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