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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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