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How can the SPC, package leaflet or labelling be amended to conform to the QRD template?

QRD-template-compliant updates to the summary of product characteristics, package leaflet or labelling can be submitted along with a clinical Type IB or Type II variation application. If the structure of the package leaflet of a medicinal product changes significantly as a result of QRD template updates, the update cannot be done along a Type IB variable, variation application. Instead, the update must be carried out either as a separate Type IB variation application (subtype C.I.z) or along with a clinical Type II variation application. Small and individual QRD template amendments can be made to the package leaflet and the labelling by filing a so-called 90-day notification.

 

When a marketing authorisation has been cancelled, how can the related information be deleted from texts that are shared with another strength or pharmaceutical form?

If the medicinal product whose marketing authorisation is cancelled has a shared SPC or package leaflet with a strength or pharmaceutical form whose marketing authorisation remains in force, the information in the cancelled marketing authorisation can be deleted from the shared text with a Type IB variation application (subtype C.I.z.). Alternatively, the information can be delete along with another variation application that affects the texts, or by submitting a so-called 90-day change notification, if only the package leaflet is common across strengths and pharmaceutical forms.

18 Nov 2015