Part II Licences and Certificates Relating to Medicinal Products
General provisions and exemptions
C28 Provisions as to manufacture and wholesale dealing. C1
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 (a) to (c) of subsection (1) of that section.
C32
No person shall, in the course of a business carried on by him, manufacture or assemble 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”).
F1C4C53
F2Subject to subsection (3C) 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
C6C7b
distribute, otherwise than by way of sale, any proprietary medicinal product F3, ready-made veterinary drug or industrially produced medicinal product other than a veterinary drug which has been imported, but was not consigned from a member State,
except in accordance with a F4wholesale dealer’s licence.
F53A
Without prejudice to the generality of subsection (3) of this section but subject to subsection (3C), no person shall, in the course of a business carried on by him, distribute by way of wholesale dealing a product to which Chapters II to V of the 1965 Directive 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 Chapters II to V of the 1965 Directive apply by the holder of a manufacturer’s licence in respect of it.
F64
Where the product which a person distributes is not a veterinary drug, subsection (3)(b) of this section shall not apply if the product is—
a
whole human blood, human blood plasma or blood cells of human origin,
b
a radiopharmaceutical in which the radionuclide is in the form of a sealed source, or
c
a homoeopathic medicinal product.
5
Where the product which a person distributes is a veterinary drug, subsection (3)(b) of this section shall not apply if the product is—
a
a vaccine, toxin or serum,
b
a product based on radioactive isotopes,
c
a product specially prepared for administration by a veterinary surgeon or veterinary practitioner to a particular animal or herd which is under his care,
d
a homoeopathic medicinal product, or
e
an additive for animal feeding stuffs to which the provisions of Council Directive 70/524/EEC apply.
6
In this section, “proprietary medicinal product”, “radiopharmaceutical” and “ready-made veterinary drug” have the same meanings as in section 7 of this Act.
F77
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.