Tagged with CCE

Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Switzerland.  1. What are the pricing models, processes and principles for originator drugs? An original drug is defined as a drug approved by Swissmedic as the first drug with a specific active ingredient, including all dosage…

Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Switzerland.  1. Price Control 1.1. How does price control at ex-factory prices work in your country? Price control is regulated in Art. 65d HIO. Triennially, the FOPH reviews whether the medicinal products included in the LS…

Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Switzerland.  1. Which are the health technology assessment (HTA) evaluation bodies and their responsibilities in your country? The National HTA program is overseen by the Health Technology Assessment Section (HTAS) of the HIBD (see above chapter…

Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Switzerland.  1. Have local authorities published recommendations and guidelines surrounding value assessment dossiers? (If yes please add link) No official guidelines or recommendations are published. However, all pending and completed HTA projects are published on the…

Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Switzerland.  1. In addition to the clinical data obtained through clinical studies please list the data required for: a. Market approval According to Art. 11 TPA, an application for marketing authorisation must contain all of the…

Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Switzerland.  1. Are there any Managed entry agreements in place in your country? (If so, please list them) 2. Describe the fundamentals of the Managed entry Agreement, its rationale and the process for implementing it. 3.…

Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Switzerland.  1. Which are the main actors involved in public procurement and tendering? The main actors involved are usually the awarding body on the one hand and a private tenderer on the other hand. For the…

Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Switzerland.  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 Based on a price comparison with 15 reference countries (containing among…

Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Switzerland.  1. Has an essential or priority drug list been published in your country? (If so provide the link) Yes, Switzerland publishes such a list in the annex to the ordinance on the Essential Human Medicines…

Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Switzerland.  1. What is the definition of an orphan drug in your country? According to Art. 4 para. 1 lit. adecies TPA, an orphan drug is a medical product for human use for which it has…

Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Switzerland.  1. What is the definition of a vaccine in your country? In Switzerland, most of the regulations related to vaccines are contained in the Federal Act on Controlling Communicable Human Diseases (EpidA; Epidemiengesetz, EpG, SR.…

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…