Description: |
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 (MA) in Malta. The importer may be someone other than the importer appointed by the MA 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. A parallel import licence is granted only for parallel imported medicinal products that fulfil the required criteria. A Parallel Import Licence is granted for a maximum of 5 years, at which time the licence must be renewed. A renewal application must be submitted at least 6 months before the expiry date such that the parallel import licence is renewed on time. |