Searching for "regulations" found 10

Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Portugal.  1. What are the pricing models, processes and principles for originator drugs? Prices of medicinal products are regulated by the System of Assessment of Health Technologies (SiNATS), approved by Decree-Law 97/2015, 1 June 2015, which…

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 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 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 1. What are the pricing models, processes and principles for originator drugs? Originator medicinal products must go through price and reimbursement proceedings (P&R Procedure) where it is decided if they are to be reimbursed or not. If reimbursed, the PVL is also fixed. To determine whether a medicinal product is…

Portugal Part of PharmaBoardroom’s new country-focused series on market access and health technology assessment (HTA), this piece gives the lowdown on post-market approval processes and regulations in Portugal. Buy The Pharma Legal Handbook: Market Access & HTA – Portugal here for £359.   What are the pricing principles and processes in your…

Asia-Pacific Writing in the April edition of DIA’s Global Forum magazine, Dhiraj Behl, Janine Jamieson, and Harikesh Kalonia highlight some of the regulatory challenges for drug-device combination products in APAC, including the lack of an international body dedicated to harmonisation in this field.   In the current innovation era and in the wake…

Pricing Pushback from drug companies on Canada’s newest drug pricing regulations has led the country’s regulatory body to reconsider their implementation. Companies cite the push for cost-effectiveness as a reason for withdrawing drug approval applications, cutting jobs, or delaying launches, claiming the new pricing regulations will substantially reduce revenues.    The…

Croatia Lawyer Ira Perić Ostojić outlines two major new regulatory updates regarding pricing and reimbursement for drugs in Croatia.   Bylaw regulating the maximum permitted wholesale price of the prescription medicinal products The bylaw regulates the detailed criteria for determining the maximum permitted wholesale price of prescription medicinal products in Croatia and…