Orphan Drugs in Panama are regulated by Law No. 419 of February 1, 2024, Executive Decree No. 13 of March 1, 2023 and Executive Decree 1217 of December 7, 2015; Rare Diseases are regulated by Law 28 of October 28, 2014.   1. What is the definition of Rare Diseases in your country? Rare, less…

What is the definition of Rare Diseases in your country? In Egypt, there is no definition of the “Rare Diseases” however, in accordance with the conclusion of medicine professors’ researches and studies a disease is considered a rare disease if it affects 1 in 2,000 or 2,500 individuals.   Does the designation of ‘Orphan Drug’…

  What is the definition of Rare Diseases in your country? There are no legal documents in Vietnam providing a definition of “rare diseases.”   Does the designation of ‘Orphan Drug’ exist in your country? (Does it correspond with the definition of Rare Diseases?) An orphan drug is a drug that is used for prevention,…

1. What is the definition of Rare Diseases in your country? In Iraq, there is no specific definition of rare diseases in the legal or regulatory framework. The concept of rare diseases generally refers to conditions affecting a small percentage of the population, but an official definition may be absent or ambiguous.   2. Does…

1. What is the definition of Rare Diseases in your country? As at the date hereof, there is no legal definition of rare diseases in Singapore. In a press release dated 2 July 2019, the Ministry of Health of Singapore (“MOH”) defined a rare disease as a condition that affects fewer than 1 in 2,000…

Orphan drugs & rare diseases in Croatia – a legal guide. Prepared in association with Danijel Pribanić, a leading global law firm, this is an extract from The Pharma Legal Handbook: Croatia, available to purchase here for GB 119.   1. What is the definition of Rare Diseases in your country? Simply put, an orphan…

An intro to the legal situation for orphan drugs and rare diseases in Czech Republic. Prepared in association with PRK Partners, a leading law firm in Czech Republic, this is an extract from The Pharma Legal Handbook: Czech Republic, available to purchase here for GBP 119.   1. What is the definition of Rare Diseases in…

Key legal info on orphan drugs & rare diseases in Peru. Prepared in association with Osterling Abogados, a leading global law firm, this is an extract from The Pharma Legal Handbook: Peru, available to purchase here for GBP 119.   1. What is the definition of Rare Diseases in your country? Rare Diseases are defined,…

Want to know more about orphan drugs & rare diseases in India? Read on! Prepared in association with Nishith Desai & Associates, a leading law firm in India, this is an extract from The Pharma Legal Handbook: India, available to purchase here for GBP 119.   1. What is the definition of Rare Diseases in…

Want to know more about orphan drugs and rare diseases in Chile? Read on! Prepared in association with Carey, a leading global law firm, this is an extract from The Pharma Legal Handbook: Chile, available to purchase here for GBP 99.   1. What is the definition of Rare Diseases in your country? Currently, we don’t…