Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Romania. 1. Which are the main actors involved in public procurement and tendering? The administrations, bodies and institutions in charge of public procurement and tendering for medicinal products in Romania are: At centralized/national level: the Ministry…
Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Romania. 1. Please describe the main cost containment policies in place in your country and their fundamental principles a. Pricing and impact of generic/biosimilar approval The price of off-patent innovative medicines cannot exceed, as a rule:…
Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Romania. 1. Has an essential or priority drug list been published in your country? (If so provide the link) The list of essential medicinal products was approved by means of a Ministry of Health’s order, published…
Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Romania. 1. What is the definition of an orphan drug in your country? The Romanian legislation defines “orphan drug” by referring to the criteria provided for by Regulation (EC) no. 141/2000 on orphan medicinal products (“Regulation…
Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Romania. 1. What is the definition of a vaccine in your country? The Health Law classifies vaccines as immunological medicinal products (any medicinal product consisting of vaccines, toxins, serums or allergenic products). 2. What are…
Romania Part of PharmaBoardroom’s new country-focused series on market access and health technology assessment (HTA), this piece is focused on the expenditure control and cost containment policies that currently exist in the Romanian pharma market. Buy The Pharma Legal Handbook: Market Access & HTA – Romania here for £359. 1.…
MEA Healthcare in the GCC continues to undergo major transformation with the introduction of government reforms, a shifting demographic and mandatory health insurance. These factors along with increased private sector participation and an ongoing infrastructure boom are poised to drive further growth in healthcare spending in the region – up to…
Greece Christian Rodseth, VP and managing director for Janssen’s Greece, Poland, and Romania cluster, outlines the multifaceted strengths of his teams, the part of the Janssen portfolio he is most excited to bring to the region, and the policy measures needed to ensure that Greek healthcare remains sustainable and able to…
Romania Mirela Iordan country manager of Pfizer Romania reveals some of her milestones, including integrating new acquisitions and setting up the first financial centre in Europe for Pfizer. She shares her insights on how the affiliate is working to maximise patients’ access to the latest innovations through patient assistance programs, early…
Romania With the 2019 acquisition of Celgene – one of the largest pharma acquisition in history – two of the sector’s most innovative oncology companies have joined forces to lead the charge against cancer. The combined entity is expected to rise in the global biopharma rankings, complete with a fresh new…
Romania According to a 2015 United Nations International Migration Report, since Romania joined the European Union in 2007, around 3.4 million Romanians have left the country in search of a better quality of life and economic opportunity. In 2019, the number of babies born in Romania was approximately 182,000, making…
Romania While the dismal regulatory environment in Romania has negatively affected the innovators with the uncertain and lengthy regulatory approval timelines as well as the dreaded ‘clawback tax’ doubling over the past decade, the generics sector has argued that they are the ones that have borne the brunt of unfavourable industry…
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