Tagged with legal

Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Denmark.    1. What is the definition of an orphan drug in your country? The term “orphan drug” usually refers to medicins used for rare diseases – i.e. diseases where the prevalence of the condition in…

Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Denmark.    1. What is the definition of a vaccine in your country? Danish legislation refers to the definition found in the European Pharmacopoeia.    2. What are the classifications of vaccines in your country? Vaccines…

Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Denmark.  1. In addition to the clinical data obtained through clinical studies please list the data required for:  a. Market approval / b. Pricing Decisions / c. Reimbursement Decisions a. Market approval Please see the detailed…

Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Brazil.  1. Please make a general introduction to the public health sector in your country and its organization As set out in the Brazilian Federal Constitution of 1988, health is a right of all and a…

Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Brazil.  1. Which are the administrations, bodies and institutions in charge of public health in your country and what are their respective responsibilities? SUS is managed collaboratively by the Federal Government, the States of the Federation,…

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 Brazil.  1. What are the pricing models, processes and principles for originator drugs? To set the price of originator drugs, CMED uses Health Technology Assessment (“HTA”) to evaluate whether a drug provides an additional therapeutic benefit…

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…