The Human Medicines Regulations 2012 No. 1916

PART 10 Exceptions to requirement for marketing authorisation etc

Exceptions

Supply in response to spread of pathogenic agents etc

174.  The prohibitions in regulation 46 (requirement for authorisation) do not apply where the sale or supply of a medicinal product is authorised by the licensing authority on a temporary basis in response to the suspected or confirmed spread of—

(a) pathogenic agents;

(b) toxins;

(c) chemical agents; or

(d) nuclear radiation,

which may cause harm to human beings.