Nitrosamines Implementation Dates

31st March 2021

Step 1 − Risk evaluation for Chemical medicines

 

1st July 2021

Step 1 − Risk evaluation for Biological medicines

 

26th September 2022

Step 2 − Confirmatory testing for Chemical medicines

 

1st July 2023

Step 3 − Update marketing authorisations for Biological medicines

 

1st October 2023

Step 3 − Update marketing authorisations for Chemical medicines

 

You can check Tox by Design methodology for Nitrosamine Impurities Assessment report, which are duly validated and signed by an European Registered Toxicologist expert.

In the event you are performing this exercise for innovative compounds GMP scale up manufacturing, please be noted that To by Design is duly accredited for the French Research Tax Credit CIR.

Feel free to contact us using the Quotation Request below to receive a quotation for Nitrosamine Impurities Assessment report for your Drug products.