17/09/2021
An intro to the legal situation for orphan drugs and rare diseases in Colombia. Prepared in association with Cavelier Abogados, a leading global law firm, this is an extract from The Pharma Legal Handbook: Colombia, available to purchase here for GBP 99. 1. What is the definition of Rare Diseases in your country? According to the ministry of health and social protection, which is the head of the health sector, rare diseases are those that affect a small number of…
08/09/2021
An intro to the legal situation for orphan drugs and rare diseases in Portugal. Prepared in association with Cuatrecasas, a leading Iberian law firm, this is an extract from The Pharma Legal Handbook: Portugal, available to purchase here for GBP 99. 1. What is the definition of Rare Diseases in your country? There is no legal definition for Rare Disease within the national legislation. However, within the European Union, diseases that affect less than five in ten thousand…
30/08/2021
An intro to the legal situation for orphan drugs and rare diseases in China. Prepared in association with Fangda Partners, one of China’s most prestigious and well-regarded law firms. This is an extract from The Pharma Legal Handbook: China, which can be purchased here for GBP 99. 1. What is the definition of Rare Diseases in your country? As of now, there is no definition of Rare Diseases in China. The List of Rare Diseases (罕见病目录) promulgated by the National Health…
29/07/2021
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 99. 1. What is the definition of Rare Diseases in your country? The relevant Czech regulation defines rare diseases as those with a very low incidence in the population, within the meaning of the relevant…
15/07/2021
Key legal info on orphan drugs & rare diseases in Swiss Pharma. Prepared in association with Wenger Plattner, a leading law firm in Switzerland, this is an extract from The Pharma Legal Handbook: Switzerland, available to purchase here for GBP 99. 1. What is the definition of Rare Diseases in your country? A disease is deemed to be rare if it affects no more than five out of every 10,000 people. 2. Does the designation of ‘Orphan Drug’ exist in…
10/07/2021
An intro to the legal situation for orphan drugs and rare diseases in Russia. Prepared in association with Lidings, a leading global law firm, this is an extract from The Pharma Legal Handbook: Russia, available to purchase here for GBP 99. 1. What is the definition of Rare Diseases in your country? The definition of rare diseases is stipulated by Art. 44 of the Federal law dd 21.11.2011 No. 323-FZ “On fundamental healthcare principles in the Russian Federation” (the…
13/05/2021
Important legal info for orphan drugs and rare diseases in Mexican pharma. Prepared in association with Olivares, a leading global law firm, this is an extract from The Pharma Legal Handbook: Mexico, available to purchase here for GBP 99. 1. What is the definition of Rare Diseases in your country? In accordance with the General health law, rare diseases are those that have a prevalence of not more than 5 people for every 10,000 inhabitants. 2. Does the…
29/04/2021
Keen to learn more about orphan drugs & rare diseases in Bulgaria? Read on! Prepared in association with Kinstellar and PharmDedict, this is an extract from The Pharma Legal Handbook: Bulgaria, available to purchase here for GBP 75. 1. What is the definition of Rare Diseases in your country? Under the Medicinal Products in Human Medicine Act (“MPHMA”), a “rare diseases” is defined as a disease characterized by an incidence not higher than 5 per 10,000 individuals. 2. Does…
20/04/2021
All legal aspects surrounding orphan drugs and rare diseases in the Polish pharma market. Prepared in association with DLA Piper, a leading law firm in Poland, this is an extract from The Pharma Legal Handbook: Poland, available to purchase here for GBP 75. 1. What is the definition of Rare Diseases in your country? There is no legal definition of Rare Diseases in Poland. On official websites the government uses the definition recommended by the EU, i.e. a rare disease…
15/04/2021
All legal aspects surrounding the orphan drugs and rare diseases in Romania. Prepared in association with Mușat & Asociații, a leading global law firm, this is an extract from The Pharma Legal Handbook: Romania, available to purchase here for GBP 75. 1. What is the definition of Rare Diseases in your country? Regulation (EC) no. 141/2000 on orphan medicinal products (“Regulation no. 141/2000”), which is directly applicable in Romania, specifies that a medicinal product could be designated by the European…
12/04/2021
The legal framework for orphan drugs and rare diseases in the Slovakian Pharma. Prepared in association with PRK Partners, a leading global law firm, this is an extract from The Pharma Legal Handbook: Slovakia, available to purchase here for GBP 75. 1. What is the definition of Rare Diseases in your country? The Slovak legislation does not have a specific legal definition for Rare Diseases. The Slovak Act on Medicinal Products rather refers to the Regulation (EC) No. 141/2000 with respect…
26/06/2020
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 have a legal or regulatory definition for rare diseases in Chile. Indeed, neither our Sanitary Code nor Supreme Decree No. 03/2010 (S.D. No. 3/10), which…
26/05/2020
The ins and outs of orphan drugs & rare diseases in Singaporean Pharma. Prepared in association with Drew & Napier LLC, this is an extract from The Pharma Legal Handbook: Singapore, available to purchase here for USD 99. 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…
14/03/2020
The key facts about orphan drugs & rare diseases in Brazil. Prepared in association with Trench, Rossi e Watanabe one of Brazil’s most prestigious law firms, this is an extract from The Pharma Legal Handbook: Brazil, which can be purchased for GBP 75, here. 1. What is the definition of Rare Diseases in your country? According to Resolution RDC No. 205/2017 issued by the National Health of Surveillance Agency (“ANVISA”), “rare diseases” are defined as diseases with incidence of up to 65…
13/03/2020
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 GBP 99. 1. What is the definition of Rare Diseases in your country? Simply put, an orphan drug is indicated for the treatment of a very rare disease. Such diseases are often caused by genetic defects and therefore children and newborns are…
Keen to learn more about orphan drugs & rare diseases in Argentina? Read on! Prepared in association with Marval, O’Farrell & Mairal, a leading global law firm, this is an extract from The Pharma Legal Handbook: Argentina, available to purchase here for GBP 99. 1. What is the definition of Rare Diseases in your country? According to Law No. 26,689 on Rare Diseases, rare diseases are considered to be those whose prevalence in the population is equal to or less than…
31/01/2020
Keen to learn more about orphan drugs & rare diseases in Turkey? Read on! Prepared in association with Moroğlu Arseven, a leading Turkish law firm, this is an extract from The Pharma Legal Handbook: Turkey, available to purchase here for GBP 75. 1. What is the definition of Rare Diseases in your country? There is no definition of rare diseases in Turkey. 2. Does the designation of ‘Orphan Drug’ exist in your country? (Does it correspond with the definition…
The ins and outs of orphan drugs & rare diseases in Japan. Prepared in association with Nishimura & Asahi, a leading law firm in Japan, this is an extract from The Pharma Legal Handbook: Japan, available to purchase here for USD 99. 1. What is the definition of Rare Diseases in your country? In Japan, there is no fixed definition for Rare Diseases, although the concept is included in the definition of Orphan Drugs (refer to Q2). It should be noted…
23/01/2020
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 75. 1. What is the definition of Rare Diseases in your country? Rare Diseases are defined, by Supreme Decree No. 004-2019-SA, as those with danger of death or chronic disability, which have a frequency of less than 1 disease per 100,000…
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 GBP 75. Orphan Drugs in Panama are regulated by Law 1 January 10, 2001, Executive Decree No. 95 of May 14, 2019 and Executive Decree 1217 of December 7, 2015; Rare Diseases are regulated by Law 28 of October 28,…
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 99. 1. What is the definition of Rare Diseases in your country? India does not have a definition of rare diseases. The National Policy on Treatment of Rare Diseases, 2020 (“NPTRD”), which is currently in…
All legal aspects surrounding orphan drugs & rare diseases in Egypt. Prepared in association with Youssry Saleh Law Firm, a leading global law firm, this is an extract from The Pharma Legal Handbook: Egypt, available to purchase here for GBP 75. 1. 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…
19/01/2020
A brief overview of the situation regarding orphan drugs and rare diseases in Algeria. Prepared in association with SAARPE Association, a leading law firm in Algeria, this is an extract from The Pharma Legal Handbook: Algeria, available to purchase here for USD 99. 1. What is the definition of Rare Diseases in your country? Rare diseases are defined in Algeria as those listed in the Ministerial Decree, dated of 6 February 2013 and published in the Official Gazette, fixing…
11/11/2019
An intro to the legal situation for orphan drugs and rare diseases in Thailand. Prepared in association with Tilleke & Gibbins, a leading law firm in Thailand, this is an extract from The Pharma Legal Handbook: Thailand, available to purchase here for USD 99. 1. What is the definition of Rare Diseases in your country? Neither the Ministry of Public Health in Thailand (MoPH) nor the Thai Food and Drug Administration (Thai FDA) has prescribed a definition for “rare diseases.” However, the…
08/09/2019
The key facts about orphan drugs and rare diseases in Ecuadorian pharma. Prepared in association with Corral Rosales, a leading global law firm, this is an extract from The Pharma Legal Handbook: Ecuador, available to purchase here for GBP 75. 1. What is the definition of Rare Diseases in your country? Our law states a specific definition for rare diseases which is the following: They are the ones that are mainly considered life threatening or that debilitate in the…
05/09/2019
All legal aspects surrounding orphan drugs and rare diseases in Canadian Pharma. Prepared in association with Fasken, a leading global law firm, this is an extract from The Pharma Legal Handbook: Canada, available to purchase here for USD 99. 1. What is the definition of Rare Diseases in your country? In Canada, “Rare Diseases” are defined as “life-threatening, debilitating or serious, and chronic conditions affecting a small number of patients, many of which predominantly affect children, as these diseases are often genetically…
17/07/2019
An insight into orphan drugs and rare diseases in Denmark. Prepared in association with Gorrissen Federspiel, a leading law firm in Denmark, this is an extract from The Pharma Legal Handbook: Denmark, available to purchase here for GBP 75. 1. What is the definition of Rare Diseases in your country? Pursuant to Regulation (EC) no. 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products (“Orphan Drug Regulation”), a medicinal product may be designated…
06/10/2019
08/10/2019
See our Cookie Privacy Policy Here
BANNER REGISTER
