The Human Medicines Regulations 2012 No. 1916

PART 5 U.K. Marketing authorisations

Obligations of holder of marketing authorisation U.K.

Record-keeping obligations U.K.

77.  The holder of a marketing authorisation [F1 or parallel import licence] must keep any documents or information that will facilitate the withdrawal or recall from sale or supply of any product to which the authorisation relates.

Textual Amendments

F1 Words in reg. 77 inserted (E.W.S.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.I. 2014/1878), regs. 1, 4 and words in reg. 77 inserted (N.I.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.R. 2014/324), regs. 1(1), 4(2)(n)