18. In regulation 28 (amendment of regulation 37 (manufacturing and assembly))—
(a)after paragraph (1) insert—
“(1A) In paragraph (2), after “Good Manufacturing Practice Directive” insert “which apply under or by virtue of regulation B17”.”.
(b)for paragraph (2) substitute—
“(2) For paragraph (4)(b) substitute—
“(b)that unless the active substance is imported into Great Britain from a country other than an approved country for import or into Northern Ireland from a country other than an EEA State from a third country, any manufacturers, importers or distributors supplying active substances to the licence holder—
(i)in the case of a product imported into Great Britain, are registered with the appropriate authority for the registration of such persons in the approved country for import, and
(ii)in the case of a product imported into Northern Ireland, are registered with the competent authority of a member State in which they are established; and”.”;
(c)for paragraph (3) substitute—
“(3) In paragraph (5)(b), after “as described” insert “in the case of a product for sale or supply in Great Britain, in the guidelines which apply under or by virtue of regulation C17 and, in the case of a product for sale or supply in Northern Ireland,”;
(d)for paragraph (4) substitute—
“(4) For paragraph (6)(b) substitute—
“(b)in the case of a product for sale or supply—
(i)in Great Britain, the UKMA(GB), UKMA(UK), COR(GB), COR(UK), THR(GB) or THR(UK), or
(ii)in Northern Ireland, the UKMA(NI), UKMA(UK), COR(NI), COR(UK), THR(NI), THR(UK), EU marketing authorisations or Article 126a authorisations,
applying to the medicinal products.”.”.