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