The key facts about biosimilars & biologics 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 USD 99.   Biological medicines in Panama are regulated by Law 1 January 10, 2001 and Executive Decree 40 of May 14, 2019.   1. Are biosimilar medicines considered the same as generic medicines in your country? No. Generic medicines are defined as medicines distributed…

Keen to learn more about orphan drugs & rare diseases in Panama? Read on! 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 USD 99.   Orphan Drugs in Panama are regulated by Law 1 January 10, 2001, Executive Decree 40 of May 14, 2019 and Executive Decree 1217 of December 7, 2015; Rare Diseases are regulated by Law 28 of October 28, 2014…

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 USD 99.   1. What types of liability are recognized in your jurisdiction? Contractual and extracontractual responsibility. These can be administrative, civil or criminal sanctions.   2. How do these types of liabilities apply to the manufacturers of medicines and devices? In general terms, manufacturers, promoters, sellers and all persons…

The low-down on the situation regarding cannabinoid drugs, medicinal cannabis and opioid drugs 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 USD 99.   Cannabinoid Drugs 1. Are Cannabinoid Drugs authorized in your country? Cannabinoids are substances subject to national control for medical or scientific use.   2. What are the regulatory authorities with jurisdiction over Cannabinoid Drugs? The regulatory authority is the Pharmaceutical…

All legal aspects surrounding regulatory reforms 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 USD 99.   1. Are there proposals for reform or significant change to the healthcare system? There are considerable proposals under analysis to change the healthcare system and the Constitution of Panama.   2. When are they likely to come into force? The new government starts the period on July…

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 USD 99.   1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? The requirements for traditional, herbal, complementary, or alternative medicines and devices that have therapeutically property are the same as for drugs. Please see Question 22. Only…

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 USD 99.   1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over the-counter medications, and other medicinal products? To obtain authorization to develop and market a product, each product must obtain a sanitary registration before the Ministry of Health. STEPS…

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 USD 99.   1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? No, it is not a requirement to conduct the clinical trials for products locally. Moreover, clinical trials are only required when the product is an innovative…

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 USD 99.   1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? The Authority that regulates drugs, biologicals and medical devices in Panama is the Ministry of Health through the following authorities: Pharmaceutical…