1. Pink Sheet
  2. >>Archive

EDQM updates guidance on revision/renewal of CEPs

 
• By Karen Finn

The European Directorate for the Quality of Medicines & HealthCare has revised its guidance on the revision/renewal of certificates of suitability (CEPs), which guarantee that the quality of companies’ pharmaceutical substances comply with the relevant monographs of the European Pharmacopoeia. The system for revision/renewal of CEPs will change for all requests received from 1 March, in line with the new Variations Regulation (Regulation 1234/2008).

The European Directorate for the Quality of Medicines & HealthCare has revised its guidance on the revision/renewal of certificates of suitability (CEPs), which guarantee that the quality of companies’ pharmaceutical substances comply with the relevant monographs of the European Pharmacopoeia. The system for revision/renewal of CEPs will change for all requests received from 1 March, in line with the new Variations Regulation (Regulation 1234/2008).

As such, the Guideline on Requirements for Revision/Renewal of Certificates of Suitability to the European Pharmacopoeia monographs1 and the Procedures...

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 Archive

Ocaliva: Still No Clarity On Why EU Court Opposed Revocation Of Approval

 
• By Neena Brizmohun

Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.

Final Chance To Have Your Say: Take Our Reader Survey This Week

 
• By Nielsen Hobbs

This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.

Shape Our Content: Take The Reader Survey

 
• By Nielsen Hobbs

We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in coverage topics, article format, or the method in which you access the Pink Sheet – or if you love it how it is – now is the time to have your voice heard.

Brazil Pilots Digital Drug Pack Inserts

 
• By Francesca Bruce

A new pilot aims to take Brazil closer to ‘digital transformation.’

More from Pink Sheet

Respiratory Treatments Hit Hardest By HTA Terminations In England

 
• By Leela Barham

Exclusive analysis by the Pink Sheet explores how non-submissions by pharmaceutical companies to England’s health technology appraisal body are impacting the availability of medicines on the National Health Service.

New Era Begins In Korea: Policy Predictions For Biopharma

 
• By Jung Won Shin

As South Korea's new president immediately gets to work on setting initial policies, essential drug supplies, R&D incentives and AI-driven digital healthcare are among the key topics in focus.

Aurobindo, MSN Fail To Beat US Nuplazid Patent Expiring In August 2038

 
• By Dean Rudge

Acadia’s Nuplazid for hallucinations and delusions associated with Parkinson’s disease psychosis appears safe from generic competition until well into the next decade, following a favorable infringement and validity decision by a US district court.