Parallel importation is the importation from an EU Member State or a country within the European Economic Area of a medicinal product, which has a Marketing Authorisation in Malta. The importer may be someone other than the importer appointed by the marketing authorisation holder of the product on the Maltese market. The medicinal product may then be parallel imported in Malta provided that the importer obtains a licence to market the product. Further information on the licensing of parallel imported products is available in the Guide to Parallel Importation of Medicinal Products.
Parallel Importation of Medicinal Products Regulations (Subsidiary Legislation 458.40)
Commission Communication on parallel imports of proprietary medicinal products for which marketing authorisations have already been granted COM (2003) 839 Final
Guide to parallel importation of medicinal products for which marketing authorisations have already been granted
Application for parallel importation of medicinal products for which marketing authorisations have already been granted
Application for the variation of a parallel import licence
Application for the renewal of a parallel import licence
General Guidelines and Recommendations on the Labelling and Packaging of Medicinal Products placed on the Maltese market
The products authorised in Malta together with the approved product information can be found in the Medicines Database.
If the Marketing Authorisation of a medicinal product is withdrawn for safety reasons, any Parallel Import Licences based on that Marketing Authorisation will be revoked. If a Marketing Authorisation is withdrawn for any other reason not related to safety, any Parallel Import Licences of the same product may be allowed to remain valid, at the discretion of the Medicines Authority.
Following recent discussions between the Medicines Authority and the European Medicines Agency (EMA) regarding issues with the availability of centrally authorised products in Malta, further information is being provided below on the possibility of parallel distribution of centrally authroised products into Malta.
A public register of parallel distribution is now available on the EMA website which provide up-to-date information on parallel distribution notices currently held by the EMA.
Where a product already includes Malta as a Member State of Destination (MSD), the products can already be placed on the market in Malta through the listed parallel distributor/s for that product.
Where the United Kingdom and/or Ireland is a member state of destination (pack is already in the English language), Malta could be added as a destination member state (where not already included) by the listed parallel distributor for that product.
The Medicines Authority should be informed of the intent to place the parallel distributed product on the market in Malta by sending a copy of the notification letter sent to the EMA by the parallel distributor, and sending copies of the labelling/mock-ups to be placed on the market in Malta, by email to parallel.medicinesauthority@gov.mt prior to marketing.
More information can be found on the EMA website.
For further information contact the Medicines Authority on parallel.medicinesauthority@gov.mt or the EMA on ParallelDistribution@ema.europa.eu .
Updated on: 6 April 2020