The Ukraine late last month became the first country to officially ratify the 47-member Council of Europe’s Medicrime Convention — the first binding international treaty to deal with counterfeit drugs and their production.
Initiated in 2010, Medicrime lays a framework for international and national cooperation on preventing counterfeit drug-related crimes and introduces minimum standards on criminal law. It also discusses ways to improve the exchange of information on counterfeit products.
Together with the EU’s new pharmacovigilance legislation that came into effect in July and the falsified medicines directive, the convention encourages more worldwide cooperation in fighting counterfeit drug crimes.
So far, 16 countries, including Israel, have signed onto the convention. Before it can come into force, five countries — including at least three from the Council of Europe — must ratify the document, Caroline Larsen le Tarnec, a spokeswoman for the European Directorate for the Quality of Medicines & HealthCare, said. She said the convention is expected to become operational by 2014.
International compliance is no longer simply a matter of playing by the same old rules. There’s been a dramatic increase in foreign inspections, and many countries are collaborating via joint inspections, confidentiality agreements and other initiatives.
And in many countries, drug safety concerns are prompting new requirements. You either learn the new rules of the game, or cede the playing field to competitors.
That’s where FDAnews’ Guide to International Pharma Regulation: 2012 Edition comes in. With this compilation of more than 150 reports highlighting changes from the past year, you could supercharge your international sales.
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