Medicines Act 1968

Exemptions from sections 52 and 53U.K.

55 Exemptions for doctors, dentists, veterinary surgeons and veterinary practitioners.U.K.

(1)The restrictions imposed by sections 52 and 53 of this Act do not apply to the sale, offer for sale, or supply of a medicinal product—

(a)by a doctor or dentist to a patient of his or to a person under whose care such a patient is, or

(b)in the course of the business of a hospital or health centre, where the product is sold, offered for sale or supplied for the purpose of being administered (whether in the hospital or health centre or elsewhere) in accordance with the directions of a doctor or dentist.

(2)Those restrictions also do not apply—

(a)to the sale or supply of a medicinal product of a description, or falling within a class, specified in an order made by the Health Ministers for the purposes of this paragraph, where the product is sold or supplied by a registered nurse in the course of her professional practice, or

(b)to the sale or supply of a medicinal product of a description, or falling within a class, specified in an order made by the Health Ministers for the purposes of this paragraph, where the product either is sold or supplied by a certified midwife (or, in relation to England and Wales, by a certified midwife or exempted midwife) in the course of her professional practice or is delivered or administered by such a midwife on being supplied in pursuance of arrangements made by [F1the Secretary of State or the Ministry of Health and Social Services for Northern Ireland].

(3)The restrictions imposed by those sections do not apply to the sale, offer for sale, or supply of a medicinal product by a veterinary surgeon or veterinary practitioner for administration by him or under his direction to an animal or herd which is under his care.

(4)Expressions to which a meaning is assigned by subsection (2) of section 11 of this Act have the same meanings in this section as in that section.

56 Exemptions in respect of herbal remedies.U.K.

(1)Subject to the following provisions of this section, the restrictions imposed by sections 52 and 53 of this Act do not apply to anything done at premises of which the person carrying on the business in question is the occupier and which he is able to close so as to exclude the public, and which consists of the sale, or offer or exposure for sale, or the supply in circumstances corresponding to retail sale, of a herbal remedy where the processes to which the plant or plants are subjected consist of drying, crushing or comminuting, with or without any subsequent process of tabletting, pill-making, compressing or diluting with water, but not any other process.

(2)Without prejudice to the preceding subsection, but subject to subsection (3) of this section, those restrictions do not apply to the sale or supply of a herbal remedy where the person selling or supplying the remedy sells or supplies it for administration to a particular person after being requested by or on behalf of that person and in that person’s presence to use his own judgment as to the treatment required.

(3)The appropriate Ministers may by order provide that subsections (1) and (2) of this section shall not have effect in relation to herbal remedies of a description, of falling within a class, specified in the order.

57 Power to extend or modify exemptions. U.K.

(1)The appropriate Ministers may by order provide that section 52 or section 53 of this Act, or both of those sections, shall have effect subject to such exemptions (other than those for the time being having effect by virtue of sections 55 and 56 of this Act) as may be specified in the order.

(2)Any exemption conferred by an order under the preceding subsection may be conferred subject to such conditions or limitations as may be specified in the order.

[F2(2A)Without prejudice to the generality of subsection (2) of this section, an order under subsection (1) of this section providing for the exemption from section 52 of this Act of the sale, or offer or exposure for sale, by retail or the supply in circumstances corresponding to retail sale of veterinary drugs by any persons—

(a)may, as a condition of the exemption, require those persons to be entered for the time being in a register of merchants in veterinary drugs kept by the registrar or the Northern Ireland enforcement authority, and

(b)may impose such conditions as the appropriate Ministers think fit in respect of the inclusion or retention of persons in the register, including conditions requiring the payment to the registrar or the Northern Ireland enforcement authority of fees of such amounts as the appropriate Ministers may with the consent of the Treasury determine.

(2B)In determining any such fees, the appropriate Ministers may have regard to—

(a)any costs incurred or to be incurred by the Pharmaceutical Society or the Northern Ireland enforcement authority in connection with any power or duty to enforce any provisions of section 52 or of regulations under section 66 of this Act, so far as those powers or duties relate to veterinary drugs, and

(b)any costs incurred or to be incurred by any other person for the purpose of maintaining or improving standards among those engaged in the sale by retail of veterinary drugs or the supply of such drugs in circumstances corresponding to retail sale.

(2C)Any fees received by virtue of this section for the inclusion or retention of any person in a register of merchants in veterinary drugs shall, if the appropriate Ministers so determine, be applied to such extent and in such manner as they may determine towards meeting any costs falling within subsection (2B)(b) of this section; subject to that, any such fees received by the registrar shall be applicable for the purposes of the Pharmaceutical Society.

(2D)In the preceding provisions of this section— “the Northern Ireland enforcement authority” means any Northern Ireland department having a duty to enforce any of the provisions referred to in subsection (2B)(a) of this section, being a duty relating to veterinary drugs; and “the registrar” means the person appointed under section 1 of the Pharmacy Act M11954 as registrar for the purposes of that Act.]

(3)The appropriate Ministers may by order provide that subsection (1)(b) or subsection (2) of section 55 of this Act shall cease to have effect, or shall have effect subject to such exceptions or modifications as may be specified in the order.

(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.