Skip to main content

Paul Cottingham

I work within the Licensing Division as the Business Support Unit manager

What is understood by 'deletion of a non-significant parameter'?

Posted by: , Posted on: - Categories: Variations
grey jigsaw with one piece missing

The Variation Classification guidelines list approximately 350 different types of variation change codes and classification sub-categories. These variations fall under three possible procedure types: TIA, TIB or TII and cover the active substance and finished product, devices and safety, efficacy, …

Submitting a variation that impacts the SmPC, label and Patient Information Leaflet (PIL)

Posted by: , Posted on: - Categories: Variations

  Several variations have a direct or consequential impact on the product information of a Marketing Authorisation (MA), by introducing changes to the SmPC and fragments, labelling and Patient Information Leaflets (PILs); these variations have a range of submission requirements …

Event updates and the new Composite Coordinated Collection (CCC) calculator

Posted by: , Posted on: - Categories: Conferences and events, Variations

MHRA Variations Masterclass and Workshop  - Third Date Added On 25 September Licensing Division held a single day event, (to be repeated on November 24), with presentations on the submission of variation procedures in the morning and two workshops (quality and …

2017 ‘Applying for an MA’ & ‘Variations Masterclass and workshop’

Posted by: , Posted on: - Categories: Conferences and events, Variations

Earlier this year, I mentioned we are planning events aimed at helping applicants submit that all elusive “ideal” data package and reduce deficiencies during assessment, to reduce the number of ‘Notification With Grounds’ (NWG) letters generated. We can now announce …