Tagged with Pharma Legal Handbook

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…

Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Brazil.  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 Generic drugs must have their PF 35% cheaper than the corresponding…

Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Brazil.  1. Has an essential or priority drug list been published in your country? (If so provide the link)   Yes. In Brazil, the National List of Essential Drugs (“RENAME”) provides the selection and standardisation of…

Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Brazil.  1. What is the definition of an orphan drug in your country? There is no specific definition for orphan drug in Brazilian current rules. However, we understand that it corresponds with the definition of rare…

Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Brazil.  1. What is the definition of a vaccine in your country? As per ANVISA Resolution RDC 55/2010, vaccines are immunobiological drugs which contain one or more substances (antigens) that, when injected into an individual, stimulate…

Pharma Legal Handbook An intro to the legal situation for regulatory, pricing and reimbursement in Panamanian Pharma. Prepared in association with AFRA, a leading global law firm, this is an extract from The Pharma Legal Handbook: Panama, available to purchase here for GBP 99.   1. What are the regulatory authorities with jurisdiction…

Pharma Legal Handbook Preclinical and clinical trial requirements in Panamanian Pharma – an overview. Prepared in association with AFRA, a leading global law firm, this is an extract from The Pharma Legal Handbook: Panama, available to purchase here for GBP 99.   Preclinical & Clinical Trial in Panama are regulated on Law 1 January 10,…

Pharma Legal Handbook An insight into marketing, manufacturing, packaging & labeling, advertising in Panama. Prepared in association with AFRA, a leading global law firm, this is an extract from The Pharma Legal Handbook: Panama, available to purchase here for GBP 99.   1. What is the authorization process for the marketing of new drugs, biologics,…

Pharma Legal Handbook A brief overview of the situation regarding traditional medicines and OTC products in Panama. Prepared in association with AFRA, a leading global law firm, this is an extract from The Pharma Legal Handbook: Panama, available to purchase here for GBP 99.   1. What are the regulatory requirements for traditional, herbal, complementary,…

Pharma Legal Handbook The legal framework for product liability in Panama. Prepared in association with AFRA, a leading global law firm, this is an extract from The Pharma Legal Handbook: Panama, available to purchase here for GBP 99.   1. What types of liability are recognized in your jurisdiction? Contractual and extracontractual responsibility. These can…