Amendment of regulation 8 of the Medicines for Human Use (Manufacturing, Wholesale Dealing and Miscellaneous Amendments) Regulations 20054
For paragraph (3) of regulation 8 of the Medicines for Human Use (Manufacturing, Wholesale Dealing and Miscellaneous Amendments) Regulations 2005 (requirement that holders of wholesale dealer's licences comply with certain obligations) M1, substitute the following paragraph—
3
The restriction in paragraph (2) shall not apply to—
a
the sale or offer for sale of any exempt relevant medicinal product;
b
the export to an EEA State, or supply for the purposes of such export, of a relevant medicinal product which may be placed on the market in that State without a marketing authorization by virtue of legislation adopted by that State under Article 5(1) of the Directive; and
c
the sale, offer for sale or supply of an unauthorised medicinal product where the Secretary of State has temporarily authorised the distribution of that product under Article 5(2) of the Directive.