PART 10Exceptions to requirement for marketing authorisation etc
Exceptions
Mixing of general sale medicinal products169
1
The prohibitions in regulation 46 (requirement for authorisation) do not apply to a medicinal product (“the product”) in respect of which the following conditions are met.
2
Condition A is that the product is manufactured by the mixing of authorised medicinal products with other authorised medicinal products, or with substances that are not medicinal products.
3
Condition B is that any authorised medicinal product that is so mixed is subject to general sale.
4
Condition C is that the product is manufactured by a person (“H”) who is the holder of a manufacturer's licence that—
a
relates specifically to the manufacture of medicinal products in accordance with this regulation; and
b
was granted or renewed not more than five years before the date on which the product is sold or supplied in accordance with paragraphs (5) and (6),
and that the product is manufactured in accordance with the terms of that licence.
5
Condition D is that the product is sold or supplied by H to a person (“P”) for administration to P or to a member of P's household.
6
Condition E is that P is present and asks H to use H's judgment as to the treatment required.
7
Condition F is that no advertisement relating to the product is published by any person.
8
Condition G is that written records of the manufacture of the product and of the sale or supply of the product are maintained and are made available to the licensing authority or to the enforcement authority on request.
9
In this regulation, “authorised medicinal product” means a medicinal product that is the subject of—
a
a F1UK marketing authorisation or EU marketing authorisation;
b
a certificate of registration; or
c
a traditional herbal registration.