New Legal Provisions on the Methodology for the Calculation and Approval of the Price of Medicinal Products

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The Government Emergency Ordinance no. 59/2016 on the amendment of Article 890 of Law no. 95/2006 was published in the Romanian Official Gazette no. 768 of September 30, 2016 (attached hereto).

According to GEO no. 59/2016, the methodology on the calculation system and approval procedure of the maximum prices of medicinal products for human use authorized for marketing in Romania is approved by Government Decision, at the proposal of the Ministry of Health.

Moreover, according to GEO no. 59/2016, the new methodology on the calculation method and approval procedure of the prices of medicinal products will be drafted and submitted with the Government for approval within 30 days since the entrance into force of GEO. No. 59/2016.

Taking into account the fact that GEO no. 59/2016 has entered into force on September 30, 2016, the new methodology on the calculation method and approval procedure of the prices of medicinal products should be drafted and submitted with the Government for approval until October 30, 2016.

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