Tagged with Denmark

Pharma Legal Handbook Keen to learn more about localization in Denmark? Read on! Prepared in association with Gorrissen Federspiel, a leading law firm in Denmark, this is an extract from The Pharma Legal Handbook: Denmark, available to purchase here for GBP 119.   1. Are there any rules or regulations requiring and/or encouraging…

Pharma Legal Handbook An insight into orphan drugs and rare diseases in Denmark. Prepared in association with Gorrissen Federspiel, a leading law firm in Denmark, this is an extract from The Pharma Legal Handbook: Denmark, available to purchase here for GBP 119.   1. What is the definition of Rare Diseases in your country? Pursuant…

Denmark In conversation at DIA Europe 2024 in Brussels, Lars Bo Nielsen lays out the digital transformation that the Danish Medicines Agency has undergone over the past three years and how AI can best be integrated into the work of national regulatory bodies.   What does AI really mean? How can…

Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Denmark.  1. Please make a general introduction to the public health sector in your country and its organization   The Danish healthcare system The Danish public healthcare system is universal – all registered Danish residents are…

Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Denmark.    1. Which are the administrations, bodies and institutions in charge of public health in your country and what are their respective responsibilities? As mentioned, the Danish public healthcare system operates across three levels: the…

Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Denmark.    1. What are the pricing principles and processes in your country? As mentioned above, there are two main markets for medicines in Denmark: the primary healthcare sector (prescription medicines) and the secondary sector (hospitals).…

Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Denmark.  1. Which are the health technology assessment (HTA) evaluation bodies and their responsibilities in your country? The Danish Medicines Council New medicines (or product with new indications) that are intended for the Danish hospital market,…

Denmark Taken from PharmaBoardroom’s new country-focused series on market access and health technology assessment (HTA), this piece gives the lowdown on the HTA decision analysis framework in Denmark. Buy The Pharma Legal Handbook: Market Access & HTA – Denmark here for £359.   Which are the health technology assessment (HTA) evaluation…

Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Denmark.    1. Please describe the main cost containment policies in place in your country and their fundamental principles  On an overall level, control of healthcare expenditures is based on budget laws and annual agreements between…

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…