Medicines: Marketing Authorisation Holders' submission of Nitrosamine risk evaluation, risk assessment and confirmatory testing
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Marketing Authorisation Holders should review their manufacturing processes to mitigate the risk of nitrosamine impurities being present.
Adapted edition
- Document type
- Reference Guide
- Format
- DOCX
- Pages
- 6
- Language
- English
- Version
- 1.0
- Updated
- 2026-09-16
- Category
- AI governance
- Licence
- Open Government Licence v3.0
Description
Marketing Authorisation Holders should review their manufacturing processes to mitigate the risk of nitrosamine impurities being present. Consult the original guidance for current legal and operational details.
Contents
- Overview
- Deadlines and scope
- Step 1
- Step 2
- Step 3
- Article 5(3) Submission of Nitrosamine risk evaluation
- Step 1 - Risk Evaluation
- Step 2 - Risk assessment and confirmatory testing
- Step 3 - Changes to the marketing authorization
- Lifecycle management
- CAPA Implementation
- Further guidance on acceptable intakes
Source and licence
Medicines and Healthcare products Regulatory Agency
AttributionMedicines and Healthcare products Regulatory Agency, ‘Medicines: Marketing Authorisation Holders' submission of Nitrosamine risk evaluation, risk assessment and confirmatory testing’ (updated 25 February 2026), reused under the Open Government Licence v3.0.
ChangesNeutral text-only adaptation from the official GOV.UK Content API body: headings, paragraphs, ordered and unordered list items and clickable source-link destinations in an appendix preserved. Images, logos, page design, accessible-format request widgets and linked attachments excluded; normalised whitespace, invisible format marks and typography.
Version history
- v1.016/09/2026