11/06/2020
In Algeria, the supplementary Finance Law for 2020 has just been published in the Official Gazette. This law materializes the authorities’ will to significantly ease the control of foreign investments in order to boost Foreign Direct Investment (FDI) and to accelerate the diversification of the national economy. Despite several…
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 USD 99. 1. What is the definition of Rare Diseases in…
30/05/2020
Want to know more about traditional medicines and OTC products in Vietnamese Pharma? Read on! Prepared in association with Tilleke & Gibbins, a leading law firm in Vietnam, this is an extract from The Pharma Legal Handbook: Vietnam, available to purchase here for USD 99. 1. What are the…
09/08/2018
A legal briefing on patents and trademarks in Argentina. 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 USD 99. 1. What are the basic requirements to obtain patent and trademark protection? Patents To obtain patent protection in Argentina, it is necessary to file a patent application before the National Institute of Industrial Property, or INPI after its acronym in Spanish (“Instituto Nacional…
13/03/2020
All legal aspects surrounding biosimilars & biologics in Argentina. 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 USD 99. 1. Are biosimilar medicines considered the same as generic medicines in your country? No, biosimilar medicines have their own legal regime. ANMAT does not use any specific term such as “biosimilar” or “biocomparable”, but defines this type of biological medicines as: “medicinal specialties…
12/02/2019
All you need to know about Marketing, Manufacturing, Packaging & Labeling, Advertising in Bolivian pharma. Prepared in association with Indacochea & Asociados, a leading Bolivian law firm, this is an extract from The Pharma Legal Handbook: Bolivia, available to purchase here for USD 99. 1. What is the authorization process for the marketing of new drugs, biologics, medical devices, non-prescription medications, and other medicinal products? The first step in order to obtain the corresponding authorization to commercialize products in Bolivia is to…
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…
09/11/2019
A brief overview of the situation regarding patents & trademarks 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 are the basic requirements to obtain patent and trademark protection? Patent The “subject matter” contained in a patent application may be patented if the following requirements are met: Novelty: Before the filing date, the subject matter must not…
29/06/2019
The key facts about regulatory, pricing, and reimbursement of drugs in Indonesia. Prepared in association with ABNR, a leading global law firm, this is an extract from The Pharma Legal Handbook: Indonesia, 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 regulatory authorities with specific jurisdiction over drugs, biologicals, and medical devices in Indonesia are: a. Ministry of Health of the Republic of…
08/10/2019
Want to know more about product liability in Czech Republic? Read on! 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 USD 99. 1. What types of liability are recognized in your jurisdiction? Two types of liability are recognized in the Czech Republic: contractual liability, arising from the failure to comply with one’s contractual obligations; non-contractual(civil)liability, arising as a consequence of…
23/10/2018
Regulatory reforms to watch out for in Portuguese pharma. Prepared in association with Cuatrecasas, a leading law firm in Portugal, this is an extract from The Pharma Legal Handbook: Portugal, available to purchase here for USD 99. 1. Are there proposals for reform or significant change to the healthcare system? Currently, a proposal to reform the Health Basis Law is under discussion. This proposal mainly focuses on the reform of the Portuguese National Health System. At the heart of this discussion are…
26/10/2018
A brief overview of the situation regarding traditional medicines and OTC products in Ukraine. Prepared in association with Sayenko Kharenko, a leading law firm in Ukraine, this is an extract from The Pharma Legal Handbook: Ukraine, available to purchase here for USD 99. 1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? Ukrainian legislation distinguishes between traditional and herbal medicines; furthermore, homeopathic preparations are as well recognized as medicines in Ukraine. There is no…
23/01/2020
Cannabinoid drugs, medicinal cannabis and opioid drugs in Egypt – an overview. 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 USD 99. Cannabinoid Drugs 1. Are Cannabinoid Drugs authorized in your country? No, Cannabinoid Drugs are not authorized in Egypt, however, they are regulated by Law No. 182 of the year 1960 concerning combating drugs and regulating their use…
07/11/2019
Key legal info on cannabinoid drugs, medicinal cannabis and opioid drugs in Nigeria. Prepared in association with Olaniwun Ajayi LP, a leading law firm in Nigeria, this is an extract from The Pharma Legal Handbook: Nigeria, available to purchase here for USD 99. Cannabinoid Drugs 1. Are Cannabinoid Drugs authorized in your country? Generally, in Nigeria, it is an offence to manufacture, sell, possess, import, export or otherwise deal in cannabinoid drugs without an appropriate license. Cannabinoid drugs may however be used…
06/11/2018
Hot-button legal issues around marketing, manufacturing, packaging & labelling and advertising in Turkish pharma. 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 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? Under Turkish laws and regulations, a registration process is required for a drug, biologic medicinal product, over-the-counter medications and…
11/10/2019
A brief overview of the situation regarding regulatory reforms 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 USD 99. 1. Are there proposals for reform or significant change to the healthcare system? Digitalization With respect to Czech legislation, the main topic of proposed regulatory changes is the ongoing process of digitalization. The Ministry of Health is keen…
26/06/2019
Preclinical and Clinical Trial Requirements in Chile – a legal guide. 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 USD 99. 1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? No. Chilean legislation and regulations do not require for clinical trials to be conducted locally in order to file for or obtain a…
28/06/2019
The low-down on the situation regarding traditional medicines and OTC products in Germany. Prepared in association with Heuking Kühn Lüer Wojtek, a leading global law firm, this is an extract from The Pharma Legal Handbook: Germany, available to purchase here for USD 99. 1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? The Medicinal Products Act contains special regulations governing Traditional Herbal Medicines and Homoeopathic Medicinal Products: 1. As per secc. 39a et…
08/11/2018
27/06/2020
