Aug 30, 2013

Alkaloid has been granted marketing authorizations for placing another two medicinal products on the European Union market

Alkaloid obtained an approval for placing two of its medicinal products on the market in the member-countries of the European Union, after a three-year procedure of comprehensive analyses, assessments and careful monitoring of national legislation specifics of countries involved in the marketing authorization procedures.

Methadone, approved in 11 countries and Cefixime, known in Macedonia as Pancef, approved in 12 EU countries, are the said medicinal products. Thus, Alkaloid obtained its first marketing authorizations on the markets in Italy and Spain.

Procedures for obtaining marketing authorizations for these medicinal products have been carried out in accordance with the strictest regulatory procedures in the European Union, such as European Decentralized Procedure, under the guidance of Medicines and Healthcare Products Regulatory Agency of United Kingdom, as Reference Member State, observing the national specific requirements of other countries included in the regulatory procedure such as Germany, Poland, Spain, Austria, Portugal, Italy, the Czech Republic, Slovakia, Romania and Hungary

In addition to the aforementioned countries, the Cefixime antibiotic (Pancef) obtained marketing authorization in France as well.

Due to its specific nature, Methadone was subjected to a detailed national analysis in all respective markets. Furthermore, Alkaloid prepared for the first time a specific application at EU level, the so-called well-established use application for marketing authorization. Based on evaluation of this full application and scientific data provided to support medicinal products quality, safety and efficacy, UK Agency concluded that Methadone product can be treated as a European reference medicinal product.

This year Alkaloid managed to achieve the level of quality through several of its products in countries that, alongside United Kingdom, have the strictest regulatory specific requirements in the European Union, such as: Germany, France, Austria, Spain and Italy.