The European Medicines Agency (EMA) has released guidance for industry with a checklist for use in advance of submission of initial notifications for parallel distribution.
The checklist provides recommendations for inclusion of information related to valid authorisations, latest versions of Annexes to Marketing Authorisations, changes in pack size, member state (MS) of origin and destination and prior notice letters for specific mechanisms.
The checklist also details information required about re-packagers, re-labelling, re-boxing, outer and inner labelling, educational material such as patient alert cards and biological product specifics, and the package leaflet.
This checklist should not be included with the submission. The answer to each point on the checklist should be ‘Yes’ unless is its not applicable (‘N/A’) to the concerned application.
To view the full guidance and checklist, click here.