Tagged with legal

Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Romania.  1. Are there any Managed entry agreements in place in your country? (If so, please list them) The Romanian legislation provides for the possibility to conclude cost-volume agreements / cost-volume-result agreements with NHIH, which will…

Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Romania.  1. Which are the main actors involved in public procurement and tendering? The administrations, bodies and institutions in charge of public procurement and tendering for medicinal products in Romania are: At centralized/national level: the Ministry…

Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Romania.  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 The price of off-patent innovative medicines cannot exceed, as a rule:…

Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Romania.  1. Has an essential or priority drug list been published in your country? (If so provide the link) The list of essential medicinal products was approved by means of a Ministry of Health’s order, published…

Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Romania.  1. What is the definition of an orphan drug in your country? The Romanian legislation defines “orphan drug” by referring to the criteria provided for by Regulation (EC) no. 141/2000 on orphan medicinal products (“Regulation…

Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Romania.  1. What is the definition of a vaccine in your country? The Health Law classifies vaccines as immunological medicinal products (any medicinal product consisting of vaccines, toxins, serums or allergenic products).   2. What are…

Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Brazil.  1. Price Control 1.1. How does price control at ex-factory prices work in your country? The Ex-Factory Price (“PF”) is defined by CMED upon application by the company requesting drug marketing authorization, in accordance with…

Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Brazil.  1. Which are the health technology assessment (HTA) evaluation bodies and their responsibilities in your country? In Brazil, CONITEC is the main HTA evaluation body, which is responsible for recommending the incorporation of health technologies…

Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Brazil.  1. Have local authorities published recommendations surrounding value assessment dossiers? (If yes please add link) Yes, but unfortunately only in Portuguese: Proposal Application Guideline. Guideline related to Cost-effectiveness.   2. Have local Authorities published guidelines…

Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Brazil.  1. In addition to the clinical data obtained through clinical studies please list the data required for: a. Market approval Each product category has its own data requirements, foreseen in specific regulations of ANVISA (which…

Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Brazil.  1. Are there any Managed entry agreements in place in your country? (If so, please list them) The first public and only managed access agreement reported in Brazil was signed between the Ministry of Health…

Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Brazil.  1. Which are the main actors involved in public procurement and tendering? As mentioned in Chapter 2, Question 7, each entity of public administration is able to carry out public procurement and tendering in order…