Rolling review for marketing authorisation applications
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Use the rolling review route when you want to submit your eCTD dossier in separate parts for pre-assessment instead of making a full consolidated document submission.
Adapted edition
- Document type
- Reference Guide
- Format
- DOCX
- Pages
- 4
- Language
- English
- Version
- 1.0
- Updated
- 2026-09-17
- Category
- Safety & operations
- Licence
- Open Government Licence v3.0
Description
Use the rolling review route when you want to submit your eCTD dossier in separate parts for pre-assessment instead of making a full consolidated document submission. Consult the original guidance for current legal and operational details.
Contents
- 1. Overview
- 2. Eligibility
- 3. How to apply
- 4. Fees
- 5. Assessment
- 5.1 Pre-assessment of modules
- 5.2 Before submission
- 5.3 Pre-submission meeting
- 5.4 Validation of applications (MAAs)
- 5.5 Final phase assessment
- 6. Appeals
- 7. Publication
- 8. Further information
Source and licence
Medicines and Healthcare products Regulatory Agency
AttributionMedicines and Healthcare products Regulatory Agency, ‘Rolling review for marketing authorisation applications’ (updated 11 March 2025), 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
- v1.017/09/2026