Paragraph 15 I1

For regulation 21 (amendment of regulation 26 (general power to suspend, revoke or vary licences)) substitute—

“21

For regulation 26(5)(a) substitute—

“(a)

that the holder of the manufacturer's licence has manufactured or assembled medicinal products to the order of a person who holds—

(i)

in the case of a product for sale or supply in Great Britain, a UKMA(GB), a UKMA(UK), a COR(GB), a COR(UK), a THR(GB) or a THR(UK) (an “authorisation”), or

(ii)

in the case of a product for sale or supply in Northern Ireland, a UKMA(NI), a UKMA(UK), a COR(NI), a COR(UK), a THR(NI) or a THR(UK), an EU marketing authorisation or an Article 126a authorisation (an “authorisation”),

and has habitually failed to comply with the provisions of that authorisation; or”.”.