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Awtorità dwar il-Mediċini



 
 

                 Parallel Importation

Parallel importation is the importation from a EU Member State or a country within the EEA of a medicinal product, which is already authorised on the Maltese-market, by an importer who is 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.

Below are links to documents related to parallel imported medicinal products:

List of Parallel Import Licenses Issued

L.N. 437 0f 2004 - Parallel Importation of Medicinal Products Regulations, 2004

Application for parallel importation of medicinal products for which marketing authorisations have already been granted.  Updated July 2009

Application for the variation of a parallel import license  Updated July 2009

Application for the renewal of a parallel import licence. Updated July 2009

Guide to parallel importation of medicinal products for which marketing authorisations have already been granted.

General Guidelines on the Re-Packaging of Medicinal Products for Human Use.

Commission Communication on parallel imports of proprietary medicinal products for which marketing authorisations have    already been granted COM (2003) 839 Final.  

 

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