LNB News 28/01/2025
Document Information
Issue Date: 28 January 2025
Published Date: 28 January 2025
Jurisdiction(s): European Union
On 28 November 2024, the European Medicines Agency (EMA)’S Pharmacovigilance Risk Assessment Committee adopted new guidelines on the use of specific adverse reaction follow-up questionnaires (Specific AR FUQs) in routine pharmacovigilance activities. The guidelines, set to take effect on 1 February 2025, outline when and how to use Specific AR FUQs, recommending their use for safety concerns that may impact a product's benefit-risk balance. The document provides guidance for Marketing Authorisation Holders (MAHs) on developing Specific AR FUQs, as well as considerations for their discontinuation and removal. It also details requirements for the content, format, and dissemination of Specific AR FUQs. The EMA notes that the guidelines do not intend to modify MAHs' internal policies for FUQs.
To continue reading this news article, as well as thousands of others like it, sign in with ÀÏ˾»úÎçÒ¹¸£Àû or register for a free trial
EXISTING USER? SIGN IN CONTINUE READING GET A QUOTE
To read the full news article, register for a free Lexis+ trial
**Trials are provided to all ÀÏ˾»úÎçÒ¹¸£Àû content, excluding Practice Compliance, Practice Management and Risk and Compliance, subscription packages are tailored to your specific needs. To discuss trialling these ÀÏ˾»úÎçÒ¹¸£Àû services please email customer service via our online form. Free trials are only available to individuals based in the UK, Ireland and selected UK overseas territories and Caribbean countries. We may terminate this trial at any time or decide not to give a trial, for any reason. Trial includes one question to LexisAsk during the length of the trial.
* denotes a required field
Scotland—the process for applying for sequestrationSequestration in Scotland is the legal process by which an insolvent debtor’s estate is gathered in, realised and then distributed among their creditors by a trustee appointed for that purpose. The process requires that a formal award of
If planning permission imposes restrictions on a licensed premises opening hours, once operational can the personal licence holder apply for a Temporary Events Notice (TEN) to open for longer hours than those permitted in the planning permission?To use any property for a licensable activity both
Financial clean break orders in family proceedingsDuty of the court to consider a clean breakAlthough there is no presumption in favour of there being a financial clean break between parties on divorce, the court is under a duty to consider whether it would be appropriate to exercise its powers so
Late payment penalties—inheritance taxWhile interest often accrues on overdue tax, the late payment of certain taxes may also attract a penalty. For information on the interest accruing on overdue tax, see Practice Notes: IHT—payment deadlines on death—Interest on IHT and Interest on late paid
0330 161 1234