Regulation 75 Obligation to provide information relating to safety etc

The holder of a UK marketing authorisation F1or parallel import licence must provide the licensing authority with any new information that might entail the variation of the authorisation.

The holder F2of a UK marketing authorisation must, in particular, provide the licensing authority with the following information—

The holder of a parallel import licence must, in particular, provide the licensing authority with—

Information within paragraph (1) F4to (2A) must be provided as soon as is reasonably practicable after the holder becomes aware of it.

The licensing authority may require the holder of a UK marketing authorisation to provide the authority with information that—

The licensing authority may require the holder of a parallel import licence to provide further information specified by the licensing authority.

The information that may be required under paragraph (4) F6or (4A) includes information arising from use of the product—

including use in clinical trials.

If the information supplied under paragraph (1), (2)F9, (4) or (4A) entails the variation of the UK marketing authorisation F10or parallel import licence, the holder must make an application to the licensing authority to that effect as soon as is reasonably practicable after becoming aware of the information.

The licensing authority may require the holder of a UK marketing authorisation to provide the authority with proof of the control methods employed by the manufacturer of the product to which the authorisation relates.

The holder of a UK marketing authorisation F11or parallel import licence must provide the licensing authority with information it requests under paragraphs F12(4), (4A) or (7)—