Tagged with Oman

Pharma Legal Handbook 1. Are there any rules or regulations requiring and/or encouraging localization in your country? What is the legal framework defining these localization rules and policies? Romania has a favourable tax regime for companies, which encourages many businesses to set up and to operate subsidiaries in Romania. However, there are no…

Pharma Legal Handbook 1. Are biosimilar medicines considered the same as generic medicines in your country? The biosimilar medicinal products are not considered the same as generic medicinal products, since the Romanian legislation regulates biosimilars and generics in a different manner. As per the local legislation, a biosimilar is a biologic medicinal product…

CEE A roundup of some of the top news coming out of the Central and Eastern European (CEE) region’s pharma industry, including Poland’s first draft of a national critical medicines list; Polpharma’s acquistion of the dermatological firm Ziołolek; Sopharma’s sale of its logistics unit, Farmalogistika; Horus Pharma’s significant stake in Romania’s…

Saudi Arabia After various leadership roles at Takeda over the course of ten years, Khaled Sary has taken on the position of general manager for the West Gulf cluster, which encompasses Saudi Arabia, Qatar, Oman and Bahrain. In conversation with PharmaBoardroom, Sary discusses the significant growth the Japanese pharma has seen in…

Market Access & Health Technology Assessment Join industry executives in staying informed on the market access and HTA process in Romania.  1. Please make a general introduction to the public health sector in your country and its organization The Romanian social health insurance system is coordinated at a central level by the Ministry of Health, the…

Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Romania.  1. Which are the administrations, bodies and institutions in charge of public health in your country and what are their respective responsibilities? The main administrations, bodies and institutions in charge of public health in Romania…

Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Romania.  1. What are the pricing models, processes and principles for originator drugs? The main enactment setting out the pricing models and approval procedures for medicines is Ministry of Health’s Order no. 368/2017 approving the Norms…

Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Romania.  1. Price Control 1.1. How does price control at ex-factory prices work in your country? In order to obtain the maximum manufacturer price approval, the medicine’s marketing authorization holder should submit an application dossier to…

Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Romania.  1. Which are the health technology assessment (HTA) evaluation bodies and their responsibilities in your country?  The National Agency for Medicines and Medical Devices (NAMMD) is the main authority that performs health technology assessments (HTA)…

Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Romania.  1. Have local authorities published recommendations surrounding value assessment dossiers? (If yes please add link) Following completion of the evaluation, NAMMD publishes the technical report (HTA report) on its website, in the section reserved for…

Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Romania.  1. In addition to the clinical data obtained through clinical studies please list the data required for: a. Market approval In addition to the clinical data obtained through clinical studies, in order to obtain the…

Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Romania.  1. Are there any Managed entry agreements in place in your country? (If so, please list them) The Romanian legislation provides for the possibility to conclude cost-volume agreements / cost-volume-result agreements with NHIH, which will…