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News & Press: Regulatory Updates

PHSS August 2017 Reg Update: Prohibition of supply; Product identifier reqs; Safety feature on pckg

02 August 2017   (0 Comments)
Posted by: Tamsin Marshall
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PHSS August 2017 Regulatory Update

 

INTRODUCTION

During the last 4 weeks, there have been a number of developments in the regulation of the pharmaceutical industry. This month reported issues have come from the EU, USA and WHO regulatory authorities.

The topics covered in this edition of the “Update” include:

 

Europe

·         Implementation plan - introduction of safety features on packaging of medicinal products

·         Prohibition of supply - Chongqing Succeway Pharmaceutical Co LTD

·         Do wholesale distributors require pharmacovigilance agreements?

·         Creating written procedures for new applicants for Wholesale Dealer Authorisations (WDA)

·         GLP Inspections metrics reflections

·         GCP inspections metrics report

 

USA

·         Product identifier requirements under the Drug Supply Chain Security Act – Compliance Policy

·         New steps to help assess opioid drugs with abuse-deterrent properties

·         Drug quality and security act and overseeing the safety of compounded drugs

·         Consumer Antiseptic Wash - Final Rule Q&A

 

International

World Health Organization (WHO)

·         Technical Report Series 1003


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