Regulation 167 Supply to fulfil special patient needs

The prohibitions in regulation 46 (requirement for authorisation) do not apply in relation to a medicinal product (a “special medicinal product”) if—

Condition A is that the medicinal product is supplied—

Condition B is that no advertisement relating to the medicinal product is published by any person.

Condition C is that—

as are adequate to ensure that the medicinal product meets the specification of the doctor, dentist, nurse independent prescriber, pharmacist independent prescriber or supplementary prescriber who requires it.

Condition D is that written records of the manufacture or assembly of the medicinal product in accordance with condition C are maintained and are available to the licensing authority or to the enforcement authority on request.

F1Except in the case of an MM medicinal product or a POC medicinal product, condition E is that if the medicinal product is manufactured or assembled in the United Kingdom F2, imported into Northern Ireland from a country other than an EEA State or Great Britain, or imported into Great Britain from a country other than an approved country for import or Northern Ireland—

In the case of an MM medicinal product, condition E is that the product is manufactured or assembled by the holder of a manufacturer’s licence (MM) that relates specifically to the manufacture or assembly of special medicinal products and in accordance with the MM master file relating to the product.

In the case of a POC medicinal product, condition E is that the product is manufactured or assembled by the holder of a manufacturer’s licence (POC) that relates specifically to the manufacture or assembly of special medicinal products and in accordance with the POC master file relating to the product.

Condition F is that if the product is F4imported into Northern Ireland from an EEA State or imported into Great Britain from F5... an approved country for import—

F8and it is imported by the holder of a wholesale dealer’s licence in relation to the product in question.

Condition G is that if the product is distributed by way of wholesale dealing by a person (“P”), who has not, as the case may be, manufactured, assembled or imported the product in accordance with paragraph (6)(a) or (7)(a), P must be the holder of a wholesale dealer's licence in relation to the product in question.

In this regulation “publish” has the meaning given in regulation 277(1) (interpretation: Part 14 advertising).