Amendment of regulation 73 of the 2012 Regulations
3. After regulation 73(5) of the 2012 Regulations (obligation to notify placing on the market etc) insert the following paragraphs—
“(5A) The holder of a UK marketing authorisation must notify the licensing authority forthwith if the holder takes action to—
(a)request the cancellation of the authorisation;
(b)not apply for the renewal of the authorisation; or
(c)withdraw the product to which the authorisation relates from the market in a third country (whether temporarily or permanently) and the action is based on any of the grounds set out in Article 116 or 117(1) of the 2001 Directive.
(5B) A notification under paragraph (3) or (5A) must include the reasons for the action, in particular declaring if the action is based on any of the grounds set out in Article 116 or 117(1) of the 2001 Directive.
(5C) The holder of a UK marketing authorisation must also notify the EMA forthwith where the action which is the subject of a notification by the holder under paragraph (3) or (5A) is based on any of the grounds set out in Article 116 or 117(1) of the 2001 Directive.”