Search across the website

Find training courses, blog posts, guidelines, knowledge base articles and more.

to navigate esc to close to open
GMP

Sponsor's report on the maintenance of the designation criteria at the time of marketing authorisation for a designated orphan-medicinal-product

Version current

Download version
Publication
-
Effective Date
-
Filename
sponsors-report-maintenance-designation-criteria-time-marketing-authorisation-designated-orphan-medicinal-product_en.doc
Checksum
3ffa5eab149fcf7b3e2e2219f914dcee382cfaa67f8f6a5e9f611f841248f73a

Change Summary

Imported from European Medicines Agency source page.

Version Change Structure

1) Rationale for the change

Not specified for this version.

2) To whom it applies

Not specified for this version.

4) The current change description

Not specified for this version.

Newsletter

Get Guideline Updates in Your Mailbox

Subscribe for major GMP/GDP guideline changes, new publications and timeline updates.

We care about your data. Read our privacy policy .