Regulation 94 Amendment of regulation 97 (breach of pharmacovigilance condition)

(1)

Regulation 97^f1, is amended as follows.

(2)

In each place where it occurs—

(a)

for “a marketing authorisation” substitute “a UK marketing authorisation”; and

(b)

for “the marketing authorisation” substitute “the UK marketing authorisation”.

(3)

In paragraph (2), after “exceptional circumstances)” insert “, regulation 60A (condition as to the testing of samples by the appropriate authority)”.

Annotations