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eCTD Industry Update (9th May 2023)

May 9, 2023
/
onix

EMA

  • IRIS guide for applicants - How to create and submit scientific applications, for industry and individual applicants (updated)
  • Provisional mandate, objectives and rules of procedure for the Nitrosamines Safety Operational Experts Group (NS OEG)
  • Medical devices (updated)
  • Contact us to discuss these updates info@onixls.com

CMDh

  • Assessment report template for the nitrosamine risk assessment for the outcome of step 2 – “nitrosamine detected” (update)
  • CMDh practical guidance for Marketing Authorisation Holders of nationally authorised products (incl. MRP/DCP) in relation to the Art. 5(3) Referral on Nitrosamines (Clean Version / Tracked Version) (update)
  • Template - D100 CMS Comments (update)
  • Template - D145 CMS Comments (update)
  • Template - D205 CMS Comments (update)
  • Template for the End of Procedure in MRP/RUP (update)
  • Contact us to discuss these updates info@onixls.com

Health Canada 

  • New Master File Application Form: Notice [2023-05-01]
  • To discuss how we can support you email us at info@onixls.com
PreveCTD Industry Update (2nd May 2023)
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