The contraceptive pill Meliane is to be discontinued due to regulatory motives relative to the local distributor, not for safety reasons, the Medicines Authority said.

Although all medicinal products have side effects, rumours were spread that the contraceptive is being withdrawn from the market because of safety issues related to negative side effects. Meliane has side effects like other contraceptives, the authority and distributors Alfred Gera and Sons Ltd said.

German producers Schering AG are stopping its distribution in the small Maltese market but the medicinal will remain available abroad. Alfred Gera and Sons Ltd confirmed with TMID that the drug will be discontinued only because it is not viable to run the costs required for the re-packaging of the product according to EU standards.

According to the European Commission’s guideline on the readability of the labelling and package leaflet of medicinal products for human use directive 2001/83/EC, all medicinal products for human use placed on the market must be accompanied by outer packaging information. A package leaflet can be omitted if the required information is directly shown on the packaging. All the information on the packaging must be in the official local languages of the EU country. The information must be accessible to those who receive it to use the medicinal product suitably.

The Medicines Authority advised women who use Meliane to consult their physician and have their medicine replaced. In January 2009, both physicians and pharmacists were informed of the discontinuation of Meliane. There is a variety of oral contraceptive medication available that can be used instead.