Kinapse commits to supporting Marketing Authorisation Holders (MAHs) regarding Nitrosamine Impurities

The deadline to respond to EMA Art. 5(3) Referral on NITROSAMINES is fast approaching. MAHs are obliged to submit the conclusions of risk evaluations for all of their medicinal products containing chemically synthesized API by 26.03.2020.

Kinapse can provide support for each step of the process, including:

  • Interpretation of the notification and how it is applicable to you
  • Developing a template for conducting nitrosamine risk assessments
  • Advise you regarding risk evaluation and mitigation
  • Support collation of all assessment information and submission of necessary templates to the EMA and/or national authorities.

Use the button below to download the PDF and learn more.

DOWNLOAD THE GUIDELINE