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 …
Since its launch in 2012 MHRA's Innovation Office has proved a popular resource with not-for-profit organisations and companies alike. We offer a free and confidential regulatory advice service that is tailored to the needs of each individual who contacts us …
From 10 April, we are removing .gsi from our email addresses.
We all know how annoying it is to arrive home after doing the weekly shop and find that we’ve bought an item that we don’t want because the labelling looked the same as the product we intended to buy. The …
Our customers have been asking us for years to move to paperless communications following submissions. With old systems and processes with long delivery timescales for change and underlying poor data quality, this was not a simple task.
Biological medicines, such as vaccines, have long been among the most important medicines available in preventing killer diseases. Increasingly, newly developed biological medicines will play an important role in global healthcare, opening up many new possibilities for the treatment of …
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 …
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 …
A variation allows the applicant to apply for changes to a marketing authorisation. Changes are classed either as minor changes which include Type 1A or Type 1B variations, or as a major change classed as a Type II.
The Product Information Quality Unit (PIQU) team often gets asked for help during a Type 1B variation procedure. This ranges from providing advice on missing documents to explaining why the proposed changes are not acceptable first time around.
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