Part II Licences and Certificates Relating to Medicinal Products
General provisions and exemptions
C2C316 The licensing authority. C1
1
For the purposes of this Part of this Act the authority responsible for the grant, renewal, variation, suspension and revocation of licences and certificates shall be F53a body consisting of the Ministers.
2
Any function conferred on the licensing authority by or under this Act may be performed F54by either of the Ministers acting alone or both of them acting jointly.
3
In accordance with the preceding provisions of this section, in this Act “the licensing authority” means F55either or both of the Ministers, and, in the case of anything falling to be done by the licensing authority, means F55either or both of the Ministers acting as mentioned in subsection (2) of this section.
C4C5C6C30C29C327 General provisions as to dealing with medicinal products. C3
1
The following provisions of this section shall have effect subject to—
C7a
any exemption conferred by or under this Part of this Act;
F57b
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
c
the provisions of section 48 of this Act.
C72
Except in accordance with a licence granted for the purposes of this section (in this Act referred to as a “product licence") no person shall, in the course of a business carried on by him, and in circumstances to which this subsection applies,—
a
sell, supply or export any medicinal product, or
b
procure the sale, supply or exportation of any medicinal product, or
c
procure the manufacture or assembly of any medicinal product for sale, supply or exportation.
F442A
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
F442B
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3
No person shall import any medicinal product except in accordance with a product licence.
F343A
The restrictions imposed by subsections (2) and (3) of this section shall not apply where the medicinal product concerned is an investigational medicinal product within the meaning of the Clinical Trials Regulations.
F413B
The restrictions imposed by subsections (2) and (3) of this section shall not apply where the medicinal product concerned is a homoeopathic medicinal product to which the 2001 Directive applies and which fulfils the conditions laid down in Article 14(1) of that Directive.
C74
In relation to an imported medicinal product, subsection (2) of this section applies to circumstances in which the person selling, supplying or exporting the medicinal product in question, or procuring the sale, supply or exportation or the manufacture or assembly for sale, supply or exportation of that product, has himself imported the product or procured its importation.
C75
In relation to any medicinal product which has not been imported, subsection (2) of this section applies to any circumstances in which the person selling, supplying or exporting the medicinal product in question, or procuring the sale, supply or exportation or the manufacture or assembly for sale, supply or exportation of that product,
F1a
is responsible for the composition of the product, or
C76
For the purposes of subsection (5) of this section a person shall be taken to be responsible for the composition of a medicinal product if (but only if) in the course of a business carried on by him—
a
he procures the manufacture of the product to his order by another person, where the order specifies, or incorporates by reference to some other document, particulars of the composition of the product ordered, whether those particulars amount to a complete specification or not, or
b
he manufactures the product otherwise than in pursuance of an order which fulfils the conditions specified in the preceding paragraph.
F46A
F56... subsection (5)(b) of this section shall not apply if the product is—
F50a
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
b
a radiopharmaceutical in which the radionuclide is in the form of a sealed source, F5 . . .
F5c
. . .
F596B
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
F67
F7In this section—
“homoeopathic medicinal product" means any medicinal product (which may contain a number of principles) prepared from F42 ..., substances F42 ... called homoeopathic stocks in accordance with a homoeopathic manufacturing procedure described by the European Pharmacopoeia or, in the absence thereof, by any pharmacopoeia used officially in a member State;
“proprietary medicinal product" means a ready-prepared medicinal product placed on the market in the United Kingdom under a special name and in a special pack;
“radiopharmaceutical" means a medicinal product which, when ready for use, contains one or more radionuclides included for a medicinal purpose; F60...
C98 Provisions as to manufacture and wholesale dealing. C8
1
The following provisions of this section shall have effect without prejudice to the operation of section 7 of this Act, but subject to the exemptions and provisions referred to in paragraphs F63(a) and (c) of subsection (1) of that section.
C102
F39Subject to F47subsections (2A) and (2C) of this sectionNo person shall, in the course of a business carried on by him, F48manufacture, assemble or import from a third country any medicinal product except in accordance with a licence granted for the purposes of this subsection (in this Act referred to as a “manufacturer’s licence”).
F352A
In the case of a medicinal product that is an investigational medicinal product, the restrictions imposed by subsection (2) of this section only apply—
a
if the product has a product licence or marketing authorization, and
b
to the extent that the manufacture or assembly of the product is in accordance with the terms and conditions of that licence or authorization.
F352B
In subsection (2A) of this section—
“investigational medicinal product” has the meaning given by the Clinical Trials Regulations; and
“marketing authorization” means—
- a
a marketing authorization issued by a competent authority in accordance with F76the 2001 Directive , or
- b
a marketing authorization granted by the European Commission under Council Regulation ( EEC ) 2309/93 F77or under Regulation (EC) No 726/2004 of the European Parliament and of the Council laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency .
- a
F452C
The prohibition in subsection (2) does not apply to a person who, in connection with the importation of a medicinal product from a third country—
a
provides facilities solely for transporting the product, or
b
in the course of a business carried on by him as an import agent, imports the medicinal product solely to the order of another person who holds a manufacturer’s licence authorising the importation of the product.
F452D
The Ministers may prescribe requirements (either generally or in relation to a prescribed class of medicinal product or activity)—
a
with which the holder of a manufacturer’s licence must comply, and
b
which are to have effect as if they were provisions of the licence.
C11C12F10 3
F11Subject to F38subsections (3C) and (3D) of this section, no person shall, in the course of a business carried on by him—
a
sell, or offer for sale, any medicinal product by way of wholesale dealing, or
except in accordance with a F13wholesale dealer’s licence.
F143A
Without prejudice to the generality of subsection (3) of this section but subject to F37subsections (3C) and (3D), no person shall, in the course of a business carried on by him, distribute by way of wholesale dealing a product to which F15the 2001 Directive applies apply except in accordance with a wholesale dealer’s licence.
3B
Distribution of such a product by way of wholesale dealing shall not be taken to be in accordance with a wholesale dealer’s licence unless, in particular, it occurs in the course of a business which is carried on at a place or places specified in the licence.
3C
The restrictions imposed by subsections (3) and (3A) of this section do not apply to anything done in relation to a product to which F15the 2001 Directive applies apply by the holder of a manufacturer’s licence in respect of it.
F363D
The restrictions imposed by subsections (3) and (3A) of this section do not apply where the product concerned is an investigational medicinal product within the meaning given by the Clinical Trials Regulations.
F463E
The Ministers may prescribe requirements (either generally or in relation to a prescribed class of medicinal product or activity)—
a
with which the holder of a wholesale dealer’s licence must comply, and
b
which are to have effect as if they were provisions of the licence.
F164
F62... subsection (3)(b) of this section shall not apply if the product is—
F51 a
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
b
a radiopharmaceutical in which the radionuclide is in the form of a sealed source, F17. . .
F17 c
. . .
F65 5
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
6
F197
In this section any reference to distribution of a product by way of wholesale dealing is a reference to—
a
selling or supplying it, or
b
procuring, holding or exporting it for the purposes of sale or supply,
to a person who receives it for the purposes of—
i
selling or supplying it, or
ii
administering it or causing it to be administered to one or more human beings,
in the course of a business carried on by that person.
8
In this Act any reference to a wholesale dealer’s licence is a reference to a licence granted for the purposes of subsection (3) or (3A) of this section.
9F75Exemptions for doctors and dentistsC15
1
The restrictions imposed by sections 7 and 8 of this Act do not apply to anything done by a doctor or dentist which—
a
relates to a medicinal product specially prepared, or specially imported by him or to his order, for administration to a particular patient of his, and consists of manufacturing or assembling, or procuring the manufacture or assembly of, the product, or of selling or supplying, or procuring the sale or supply of, the product to that patient or to a person under whose care that patient is, or
b
relates to a medicinal product specially prepared at the request of another doctor or dentist, or specially imported by him or to his order at the request of another doctor or dentist, for administration to a particular patient of that other doctor or dentist, and consists of manufacturing or assembling, or procuring the manufacture or assembly of, the product, or of selling or supplying, or procuring the sale or supply of, the product to that other doctor or dentist or to that patient or to a person under whose care that patient is.
F67C162
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
F673
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
C1810 Exemptions for pharmacists. C17
1
F68... the restrictions imposed by sections 7 and 8 of this Act do not apply to anything which is done in a registered pharmacy, a hospital F20, 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 a practitioner, or
b
assembling a medicinal product F21provided 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.
F692
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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, F70...
F70b
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4
Without prejudice to the preceding subsections, the restrictions imposed by sections 7 and 8 of this Act 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 F22provided 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.
F235
Without prejudice to the preceding subsections, the restrictions imposed by section 7 of this Act 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 section 8(2) of this Act 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.
F71F24 6A
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
7
Without prejudice to the preceding subsections, the restrictions imposed by section 8(3) F25or (3A) of this Act do not apply to anything which is done in a registered pharmacy by or under the supervision of a pharmacist and amounts to wholesale dealing, where such dealing constitutes no more than an inconsiderable part of the business carried on by the pharmacist at that pharmacy.
F527A
The F72... 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 section 92 of this Act, except that it shall not include words inscribed on the medicinal product, or on its container or package.
F269
In subsection (1) of this section, “care home service" has the meaning given by F79paragraph 2 of schedule 12 to the Public Services Reform (Scotland) Act 2010 (asp 8).
11 Exemption for nurses and midwives. C19
1
2
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . F29
12 Exemptions in respect of herbal remedies. C20
1
The restrictions imposed by sections 7 and 8 of this Act do not apply to the sale, supply, manufacture or assembly of any herbal remedy in the course of a business where—
a
the remedy is manufactured or assembled on premises of which the person carrying on the business is the occupier and which he is able to close so as to exclude the public, and
b
the person carrying on the business sells or supplies the remedy 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.
F782
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
13 Exemptions for imports. C21
1
The restriction imposed by section 7(3) of this Act does not apply to the importation of a medicinal product by any person for administration to himself or to any person or persons who are members of his household, and does not apply to the importation of a medicinal product where it is specially imported by or to the order of a doctor or dentist for administration to a particular patient of his.
2
Without prejudice to the preceding subsection, the restriction imposed by section 7(3) of this Act shall not apply to the importation of a medicinal product in such circumstances as may be specified in an order made by the Ministers for the purposes of this section.
3
Any exemption conferred by an order under this section may be conferred either in relation to medicinal products generally or in relation to a class of medicinal products specified in the order, and (in either case) may be so conferred subject to such conditions or limitations as may be so specified.
C2314 Exemption for re-exports. C22
F301
F31Subject to subsection (2) of this section, the restrictions imposed by sections 7 and 8 of this Act do not apply to the exportation, or the sale or offer for sale for the purposes of exportation, of any imported medicinal product if it is, or is to be, exported—
a
in the form in which it was imported, and
b
without being assembled in a way different from the way in which it was assembled on being imported.
F322
15 Provision for extending or modifying exemptions. C24
1
The F73... Ministers may by order provide that sections 7 and 8 of this Act shall have effect subject to such exemptions (other than those for the time being having effect by virtue of sections 9 to 14 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.
3
The F74... Ministers may by order provide that any of the provisions of sections 9 to 14 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.
16 Transitional exemptions. C25
C261
The restrictions imposed by sections 7 and 8 of this Act do not apply to anything done before such day as the Ministers may by order appoint for the purposes of this subsection (in this Act referred to as “the first appointed day”); and, except as otherwise provided by any order made under section 17 of this Act, the following provisions of this section shall have effect in relation to things done on or after that day.
C272
Section 7(2) of this Act shall not have effect in relation to a person in respect of his selling or supplying, or procuring the sale, supply, manufacture or assembly of, medicinal products of any description if, in the course of a business carried on by him, any medicinal products of that description were sold or supplied, or procured to be sold, supplied, manufactured or assembled, at any time before the first appointed day and medicinal products of that description were effectively on the market in the United Kingdom immediately before the first appointed day, and either—
a
information with regard to the composition of medicinal products of that description, and as to their being available for sale or supply in the United Kingdom, had before that day been made known generally to doctors, or to any particular class of doctors, or to dentists or pharmacists, or to veterinary surgeons and veterinary practitioners, in the United Kingdom, or
b
information that the products were available for sale or supply in the United Kingdom had before that day been made known generally to the public in the United Kingdom.
C273
Section 7(3) of this Act shall not have effect in relation to a person in respect of his importing medicinal products of any description in the course of a business carried on by him if, in the course of that business, medicinal products of that description were imported within the period of twenty-four months ending with the first appointed day.
C274
Section 8(2) of this Act shall not have effect in relation to a person in respect of his manufacturing or assembling medicinal products of any description in the course of a business carred on by him if in the course of that business—
a
medicinal products of that description were manufactured or assembled within the period of twelve months ending with the first appointed day, or
b
medicinal products of that description were manufactured or assembled before the beginning of that period and further supplies of such products could, if required, have been manufactured or assembled within that period:
Provided that this subsection shall not have effect in relation to any particular operations carried out in the course of a business on or after the first appointed day unless the manufacture or assembly of the products as mentioned in paragraph (a) or paragraph (b) of this subsection, as the case may be, included those operations.
C275
Section 8(3) of this Act shall not have effect in relation to a person in respect of his selling or offering for sale any medicinal products by way of wholesale dealing in the course of a business carried on by him if, in the course of that business, medicinal products were being sold or offered for sale by way of wholesale dealing within the period of twelve months ending with the first appointed day.
17 Termination of transitional exemptions. C28
For the purposes of subsections (2) to (5) of the last preceding section, the Ministers may by one or more orders under this section appoint one or more days, subsequent to the first appointed day, and may by any such order provide that such one or more of those subsections as may be specified in that order shall cease to have effect either—
a
generally in relation to anything done on or after the day appointed by that order, or
b
in relation to anything done on or after that day in so far as it consists of operations or activities, or relates to medicinal products of any such class, as may be so specified.