On July 25, the Government approved amendments to the governmental regulation on state registration of the manufacturer’s price for imported medicines. The amendments have covered the legislative gap that had been occurring whenever the manufacturer’s price for imported drugs would not be registered in three “reference countries”, which was a recurrent situation since the majority of EU countries do not register prices for non-reimbursed over-the-counter medicines. The new national regulation keeps the system of external reference pricing but provides solutions by factoring in the price registered or notified in the country of origin, and other relevant data, whenever there are no available registrations in the established “reference countries”. The new version of the regulation includes the recommendations that have been advocated by AmCham Moldova members on a long-term basis and is expected to be officially published in the upcoming weeks.
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