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 …
Don’t worry, we’re not talking Shakespeare and it’s ‘B’ for baselines – we want to help you understand when a baseline might be required and what it should contain. From January 2019 the EU eSubmissions Roadmap will mandate the use …
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 …
We are delivering cutting-edge technology to improve processes, introduce automation and enhance customer services throughout 2018. Our Information Processing Unit is in the middle of a four-year reform programme designed to improve its services, operations and overall efficiency while …
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 …
MHRA regularly consults its stakeholders on many issues. As Head of Economics I use the consultation responses to gather new evidence to see if we’ve got our policy right, or if we need to change it. It is extremely satisfying …
The Information Processing Unit (IPU) is a part of the Information Management Division at MHRA. As the main submission hub for the Agency, in IPU we are responsible for making sure regulatory applications relating to Marketing Authorisations and Clinical Trial …
In the coming weeks, you will notice that it’s much quieter than usual on this blog. It’s because between midnight on Friday, 21 April and the general election on 8 June is the pre-election period. This means that we communicate …
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 …
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