Parallel ­distribution

Parallel distribution of a medicinal product means the sale of a centrally authorised medicinal product in an EEA country other than that for which it was originally manufactured and released.

A parallel distributed medicinal product has the same name and is exactly the same product as the directly imported medicinal product.

It is repackaged or relabelled with a Swedish label by an approved repackager and is accompanied by a Swedish package information leaflet.

Application for parallel distribution

Parallel distribution is handled by the European Medicines Agency (EMA). General questions relating to the parallel distribution of medicinal products should therefore be referred to the EMA.

The Swedish MPA receives information from the EMA when a medicinal product has been authorised for parallel distribution. Information on package size and responsible distributor is entered in the National Substance Register for Medicinal Products (NPL).

Changes to the product are implemented simultaneously in all countries. However, due to different stock levels, the previous and modified products may be available in parallel for some time after a change has been made.

Products with conditions in the marketing authorisation

For products with conditions relating to educational materials or controlled distribution in the marketing authorisation, a parallel distributor must agree with the Swedish MPA on how they will ensure that the conditions of the authorisation are met before the product starts to be parallel distributed. This is done via a notification to the Swedish MPA.

Form for notification

This may also apply to any other conditions which are stipulated in the product’s marketing authorisation. Contact the Swedish MPA for an assessment in such cases.

The conditions are described in Annex IID to the European public assessment report (EPAR) – product information, on the EMA’s website.

Educational materials as a condition

The marketing authorisation holder (MAH) must reach agreement concerning the details of educational material with the national authority prior to launch of the product.

Parallel distributors are not obliged to provide their own educational or information material in addition to the approved labelling and package leaflet, but they must ensure that the educational material is available to the relevant target group (e.g. prescribers and/or pharmacies). This can be done by contacting the MAH.

Controlled distribution as a condition

The MAH must reach agreement on the details of a controlled distribution system with the national authority. To ensure patient safety, a distribution system similar to that established by the MAH must therefore also be set up by the parallel distributor.

The Swedish MPA assesses each proposed solution on a case-by-case basis on the basis of the scope to fulfil the conditions and safeguard the objective of the controlled distribution. This means that different solutions will be possible for different operators.