HMA publishes updated CMDv members list and issues updated guidance from CMDv regarding handling of PSURs and naming of products

30 September, 2016

The HMA has published updated versions of the following:

  • CMDv/BPG/020 – Best Practice Guide for Handling of Periodic Safety Update Reports (PSURs) in the context of the EU PSUR Worksharing (Link)
  • The HMA has published an updated version of CMDv/GUI/007, the List of the CMDv members and their qualifications (Link).

The HMA has also released a new position paper, CMDV/POS/005, on agreeing the product name during the Decentralised Procedure (Link).

Business Units: 

Regulatory Outsourcing Options

Cyton’s dedicated regulatory procedures team can support you with:
 - Dossier preparation, submission & regulatory procedures
 - Regulatory intelligence and strategic planning
 - Life cycle management
 - Key person cover
 - Pharmacovigilance
 - Brexit support services