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Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Denmark.    1. Have local authorities published recommendations/guidelines surrounding value assessment dossiers? (If yes please add link) The Danish Medicines Agency has published two main guidelines: i) The Danish Medicines Council’s process guide for assessing new…

Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Denmark.    1. Are there any Managed entry agreements in place in your country? (If so, please list them) There have been examples of use of managed entry agreements in Denmark. For example, Amgros may enter…

Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Denmark.    1. Which are the main actors involved in public procurement and tendering? During the tender: The main actors involved in a public tender are the contracting authority, i.e., the authority that needs to procure…

Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Denmark.    1. Has an essential or priority drug list been published in your country? (If so provide the link) The guideline process of the Danish Medicines Council results in recommendations with prioritized list of medicines…

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,…

Saudi Arabia SaudiVax, a pioneering force in the halal vaccines field, has recently expanded its focus to include biologics, aligning with broader market trends towards vegan and Halal products. Co-Founder and Managing Director Prof. Mazen M. Hassanain outlines how the company has shifted its distributor strategy to form partnerships with small to…

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…