I work within the Licensing Division as the Business Support Unit manager
My last blog on 'variations' looked at the importance of choosing the right change code, as there are about 350 in total. It can also be tricky choosing the correct procedure, whether that’s minor (Type IA and Type IB) or …
There can be a degree of uncertainty when it comes to writing and formatting an expert report. Companies will often ask questions such as: What is expected from the expert report? Is there a minimum qualification/requirement for acting as a …
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, …
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 …
March 19th saw the third variations masterclass & workshop (a repeated, single day event) conclude with an overall attendance of 143 delegates from 104 companies. Presentations were held in the morning covering the submission of variation procedures involving Patient Information …
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 …
When updating product licence details, there are always areas in the variation submission processes (both National and Mutual Recognition (MR)) which can cause validation issues or the generation of Notification with Grounds (NWG) letters, ultimately resulting in a rejection or …
The Regulatory Information Service (RIS) was formed in 2006 to act as a main point of contact for industry and their representatives for a range of enquiries - from simple administrative queries right through to complex regulatory queries - and …