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 …
Administrative changes can be either Type 1A or Type 1B and are considered minor variations. These include company name, postcode and/or address changes, the removal of redundant sites, and drug substance name changes. Additionally, changes can include ‘Quality Review of …
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 …
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 …
A batch-specific variation is a variation application to request agreement for a single or small number of batches of product to be released outside of the usual conditions of the marketing authorisation. Every year we receive more than 200 batch …