The European Medicines Agency (EMA) on Monday announced that going forward, parallel distributors will be required to use its recently launched
secure online portal, known as Iris, to manage and submit parallel distribution notifications.
Parallel distribution, also known as re-exportation, is a process by which companies in the EU distribute centrally authorized medicines between member states, independent of their marketing authorization holder (MAH). The practice allows for cheaper drugs to be distributed from one member state to another where they can be sold at a markup.
Under Directive 2001/83/EC
, parallel distributors are required to give notice to EMA and the MAH when they intend to re-export a product, as well as pay a fee to the agency to review the notification.
EMA first launched the Iris portal last June for managing and submitting requests for orphan designation as part of an effort to consolidate and integrate
its information management systems.
The agency says that Iris should make it easier for parallel distributors to process and keep track of parallel distribution notices while providing the agency with better data.
“The streamlining of the processes will reduce the time needed for parallel distributors to prepare and submit notifications and ensure better data quality through integration with other EMA systems,” EMA writes.
EMA also says that parallel distributors will be able to use Iris to check the status of their notifications and receive automatic updates whenever the status of a notification changes.
Additionally, EMA has issued a new guideline
on using Iris for parallel distributors and has updated its guideline on registering
for the system.
With EMA’s move to Amsterdam underway, the agency says it will be suspending the submission of parallel distribution annual updates for three months from 1 February through 30 April.
EMA also says it will stop posting physical notice letters between 15 February and 1 April, after which individually signed letters may be requested if needed.