Amendment of regulation 195

21.  In regulation 195 (obligation on the licensing authority to assess PSURs where EU single assessment procedure does not apply), for paragraph (1)(a) and (b) substitute—

“(a) the medicinal product to which the PSUR relates—

(i) has not been authorised to be placed on the market in accordance with the 2001 Directive in an EEA State other than the United Kingdom; and

(ii) a harmonised EU reference date and frequency of submission of PSURs have not been established for that product under Article 107c of the 2001 Directive; or

(b) the medicinal product is one that is imported into the UK under a parallel import licence.”