The Agency fulfils its obligation to check the conditions of parallel distribution by means of five procedures.

Initial Notification

An initial notification is a parallel distributor’s notification to the Agency, informing of their intent to source, repackage and distribute a centrally authorised medicinal product from one or more Member States to one or more Member State(s). The Agency checks compliance of the particulars of this notification with the marketing authorisation and EU legislation on medicinal products and issues a PD notice when the check confirmed that for the medicinal product distributed in parallel, the conditions laid down in the EU legislation on medicinal products and in the marketing authorisation were observed at the time of issuance. For further information on how to submit an initial notification, please refer to the section Initial notification.

Safety Updates

Urgent safety updates to the originator product information are notified to the parallel distributor by EMA on a monthly basis. The resulting safety update by the parallel distributor to verify the update to their product information shall be submitted within a three-month timeframe of the notification by the Agency of the urgent safety update having occurred, otherwise the notification will be invalidated. Urgent safety update is not subject to any fee and it does not affect the duty to submit an annual update. One or more EU presentations of the same product with the same Member State of Destination can be included in a single submission. No other scopes of changes can be added to such notifications.

For further information please refer to the section Safety updates/bulk changes/annual updates.

Bulk Change (change of manufacturer, change of name and/or address, reassignment of notices for parallel distribution)

A bulk change is a notification of changes that affect all parallel distributor’s notices, at any point in time after the approval of the initial notification. The scopes of change are limited to changes in the Re-packager’s information, Update of parallel distributor’s name and/or address, and Reassignment of PD notices. The procedure aims to provide the possibility of implementing a scope of change for all notices held by one company.

Update of parallel distribution notice status

The purpose of this procedure is to allow the parallel distributor to update the status of their notice to ‘dormant’, ‘active’ or ‘withdrawn’ in a simplified procedure. The update of the status does not incur a fee or require a regulatory check and is therefore merely confirmed following receipt based on a declaration that parallel distributors are aware of the obligations/consequences related to the activation of dormant presentation, or request to withdraw a notice.

To change status of notice, parallel distributors can combine many products in one single submission. However, if a dormant product is being reactivated, it is mandatory to simultaneously submit an annual update notification for that said product. The product can be then distributed in parallel once again, from the day of status update in IRIS, provided that the Agency has been made aware of the changes which have occurred since the product was dormant.

Annual Update

The purpose of the annual update is to combine all scopes of changes occurring within one year to one pharmaceutical form of a medicinal product with one Member State of destination in one application. It is aimed at maintaining an up to date database. 

For further information please refer to the section Safety updates/bulk changes/annual updates.