Classification of UK marketing authorisation and certificate of registrationU.K.
4.—(1) Sub-paragraph (3) applies to a UK marketing authorisation granted before 1st April 2002 if—U.K.
(a)the authorisation contains a statement that the product to which the authorisation relates is to be available on one or more of the bases set out in paragraph (2); or
(b)the product to which the authorisation relates is to be available on one or more of the bases set out in paragraph (2) by virtue of any enactment in force immediately before the coming into force of these Regulations.
(2) Those bases are that the product is to be available—
(a)only on prescription;
(b)only from a pharmacy; or
(c)on general sale.
(3) It is a condition of the UK marketing authorisation that the product is only to be available on that basis or those bases.