PART 10Exceptions to requirement for marketing authorisation etc
Exceptions
Use of non-prescription medicines in the course of a business168
1
The prohibitions in regulation 46 (requirement for authorisation) do not apply to anything done in relation to a medicinal product if the following conditions are met.
2
Condition A is that the medicinal product is not a prescription only medicine.
3
Condition B is that the medicinal product is sold or supplied to a person who is a health care professional (“P”) exclusively for use by P—
a
in the course of a business carried on by P, and
b
for the purposes of administering it or causing it to be administered otherwise than by selling it.
4
Condition C is that the medicinal product is—
a
manufactured and assembled in accordance with the specification of P; and
b
for use by a patient for whose treatment P is directly responsible in order to fulfil the special needs of that patient
5
Condition D is that if sold or supplied through the holder of a wholesale dealer's licence the medicinal product is sold or supplied to such a person and for such use as mentioned in condition B.
6
Condition E is that no advertisement relating to the medicinal product is published by any person.
7
Condition F is that the sale or supply of the medicinal product is in response to an unsolicited order.
F18
Condition G is that if the medicinal product is—
a
manufactured or assembled in the United Kingdom or imported into the United Kingdom from—
i
in the case of a product for sale or supply in Northern Ireland, a country other than an EEA State, or
ii
in the case of a product for sale or supply in Great Britain, a country other than an approved country for import,
it is manufactured, assembled or imported by the holder of a manufacturer's licence that relates specifically to the manufacture, assembly or importation of special medicinal products, or
b
imported into—
i
Northern Ireland from an EEA State, it is manufactured or assembled in that State by a person who is the holder of an authorisation in relation to its manufacture or assembly in accordance with the provisions of the 2001 Directive as implemented in that State, or
ii
Great Britain from an approved country for import—
aa
it is manufactured or assembled in that country by a person who is the holder of an authorisation in that country in relation to its manufacture or assembly, and
bb
it is imported by the holder of a wholesale dealer's licence under Part 3 that includes the import of a medicinal product from such a country.
9
In this regulation “publish” has the meaning given in regulation 277(1) (interpretation: Part 14 advertising).