Paragraph 38 Application or notification made before IP completion day in respect of a variation under Chapter IIa of Regulation (EC) No 1234/2008 (variations to purely national marketing authorisations)F1

an application or notification in respect of a variation to a UK marketing authorisation has been submitted to the licensing authority under Chapter IIa of Regulation (EC) No 1234/2008 before IP completion day; but

the procedures specified in Article 13e of that Regulation (measures to close the variation procedures in Chapter IIa of that Regulation) have not concluded before IP completion day.

determine which of the provisions specified in Schedule 10A that are relevant to that application or notification need to be taken on or after IP completion day, having regard to the steps that have already been undertaken under Chapter IIa of Regulation (EC) No 1234/2008 before IP completion day;

assess the application or notification in accordance with the provisions of that Schedule the authority has determined are relevant to the application, as if the application or notification had been made under them; and

take all reasonable steps to ensure that it assesses the notification or application in accordance with any relevant time period specified in that Schedule, as if the application had been made under the provisions in that Schedule before IP completion day.