The Medicines for Human Use (Marketing Authorisations Etc.) Amendment Regulations 2009
These Regulations amend the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994 (“the 1994 Regulations”) by removing the obligation on the licensing authority to consult the appropriate committee (as defined in regulation 1(2) of the 1994 Regulations) before refusing to grant or renew a marketing authorization on grounds relating to safety, quality or efficacy in any case where the licensing authority has requested the applicant to supply information which it regards as relevant to enable the application to be determined and the relevant period has expired without that information having been supplied. The Regulations make provision as to determination of the relevant period and the possibility of its extension at the request of the applicant.