Slovakia Eases Market Access For Innovative Medicines

Slovakia has introduced a new system for agreeing managed entry agreements that will make it easier for companies to get their innovative medicines to the market.

Slovakia
Slovakia rethinks managed entry agreements • Source: Shutterstock

A new regulatory amendment now in force in Slovakia will make it easier for companies to strike managed entry agreements (MEAs) and therefore secure market access, according to the law firm Allen and Overy. The changes will also bring Slovakian regulations further into line with European standards, according to lawyers.

An amendment to Slovakia’s 2012 Reimbursement Act (Act No. 363/2011 Coll) came into force in August. “This is so far the most significant change in the system of market access since 2012, when the Reimbursement Act became effective,” according to Michal Porubsky and Nina Garajova, lawyers from Allen and Overy based in Slovakia

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