1. Pink Sheet
  2. >>Drug Safety

MHRA Explains Its Approach To New 'Safety Features' In 2019

 
• By Ian Schofield

The MHRA has set out its position on those aspects of the new “safety feature” rules for prescription drugs where member states have flexibility to choose their options, such as the information to be included in the “unique identifier” and the conditions for “checking out” medicines from the verification system. The European Medicines Verification System is being introduced as part of the EU Falsified Medicines Directive.

Verification Log In User Password Register Concept
The UK MHRA has explained its position on aspects of the EU drug verification system

The UK regulator, the MHRA, says that the safety feature to be affixed to medicine packs as of February next year will not have to include a national reimbursement or other identification number, but that other information can be included provided it has been appropriately assessed by the agency. It has also explained its position on decommissioning of products from the EU verification system.

Under the European Medicines Verification System, which is being introduced as part of the EU Falsified Medicines Directive, all prescription drugs will have to carry a safety feature consisting of...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Drug Safety

MAHA Commission Outlines Enhanced Research On Drug Safety In Children

 
• By Cathy Kelly

Research would include initiatives on reproducing industry-sponsored studies, postmarket surveillance, and studies of long-term neurodevelopmental and metabolic outcomes for commonly prescribed pediatric drugs.

US FDA Will Help States Apply To Import Cheaper Drugs From Canada

 
• By Cathy Kelly

The FDA is not currently signaling that stringent rules for the process will be relaxed, but the agency's change in approach is notable.

International Group Aims To Shape The Inevitable Future Of AI In Pharmacovigilance

 
• By Urtė Fultinavičiūtė

Pharmacovigilance is a perfect rule-based and manual work-intensive playground for experimenting with AI. While some off-patent drug firms are already exploring new automation tools, regulation is lagging behind, leaving a gap for uncertainty.

Safety Review Prompts EMA to Suspend Ixchiq Chikungunya Vaccine For Seniors

 
• By Neena Brizmohun

The European Medicines Agency is investigating whether Valneva’s Ixchiq is safe to use in the elderly, following reports of 17 serious adverse events, including two cases resulting in death, in people aged 62 to 89 years who received the vaccine. This follows actions by US and French authorities last month regarding Ixchiq’s use in people over 65.

More from Pink Sheet

EMA Says Digital Transformation A ‘Fundamental Shift’ In Meeting Regulatory Challenges

 
• By Eliza Slawther

Sponsors can expect faster evaluation processes for key medicines and greater support in mitigating medicines supply shortages this year as part of the European Medicines Agency’s digital transformation overhaul.

EU CHMP Opinions And MAA Updates

 
• By Neena Brizmohun

This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.

HHS Rescinds COVID-19 Vaccine Advice, Usurping US CDC Role

 
• By Sue Sutter

By stepping into the role of the Centers for Disease Control and Advisory Committee on Immunization Practices, HHS Secretary Robert F. Kennedy Jr. is causing further confusion and uncertainty about vaccine policy, experts say.