Regulation 151 Amendment of regulation 191 (obligation on holder to submit periodic safety update reports: general requirements)I1

for sub-paragraph (b) substitute—

“(b)

where—

(i)

in relation to a product authorised under a UKMA(NI) or UKMA(UK), the product has not yet been placed on the market within the EEA or Northern Ireland, at least every six months following authorisation until the placing on the market within the EEA or Northern Ireland, or

(ii)

in relation to a product authorised under a UKMA(GB), the product has not yet been placed on the market in Great Britain, at least every six months following authorisation until the placing on the market within Great Britain; and”;

for sub-paragraph (c) substitute—

“(c)

where—

(i)

in relation to a product authorised under a UKMA(NI) or UKMA(UK), the product has been placed on the market within the EEA or Northern Ireland—

(aa)

at least every six months during the first two years following the initial placing on the market,

(bb)

once a year for the following two years, and

(cc)

every three years after that;

(ii)

in relation to a product authorised under a UKMA(GB), the product has been placed on the market in Great Britain—

(aa)

at least every six months during the first two years following the initial placing on the market,

(bb)

once a year for the following two years, and

(cc)

every three years after that.”.