13/05/2021
Key facts about biosimilars and biologics in Mexico. 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. Are biosimilar medicines considered the same as generic medicines in your country? No, biosimilars…
08/06/2021
There is no doubt that COVID-19 has impacted almost every aspect of our lives. Due to the ongoing health crisis, among other efforts, governments have implemented measures expecting to break high rates of infection while trying to adapt the regulatory landscape to respond to the new virus and continuing to…
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…
29/08/2018
All you need to know about regulation, pricing and reimbursement 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 are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? The authority responsible for applying and enforcing the regulatory framework in relation to human medicines, biologicals, and medical devices is the…
28/01/2019
A brief overview of the situation regarding regulation, pricing and reimbursement of drugs in Canada. 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 are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? Health Canada is the federal authority responsible for regulating pharmaceutical drugs, biologicals, and medical devices for human use. Health Canada’s…
23/01/2020
The ins and outs of biosimilars & biologics 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. Are biosimilar medicines considered the same as generic medicines in your country? No, they are different. On one side biosimilar products are biologically synthesized products which require a much more complex procedure to elaborate due to the fact that bigger…
01/03/2019
The key facts about conducting preclinical and clinical trials in Singapore. 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. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? No, there is no such express statutory requirement under Singapore legislation. 2. How are clinical trials funded? Clinical trials may be funded by pharmaceutical companies, hospitals,…
The key facts about the localization in Indian Pharma. 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 75. 1. Are there any rules or regulations requiring and/or encouraging localization in your country? What is the legal framework defining these localization rules and policies? There are no specific legislations or regulations requiring and/or encouraging localization in India. 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 GBP 75. 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…
31/01/2020
Biosimilars & biologics in Russia – a comprehensive legal overview. 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 USD 99. 1. Are biosimilar medicines considered the same as generic medicines in your country? Biosimilar drugs are not the same as generic drugs in Russia. A biosimilar drug cannot be a copy of the original biological drug, as in respect of a biosimilar drug it…
22/01/2020
Keen to learn more about patents & trademarks in Belgium? Read on! Prepared in association with ALTIUS, a leading law firm in Belgium, this is an extract from The Pharma Legal Handbook: Belgium, available to purchase here for USD 99. 1. What are the basic requirements to obtain patent and trademark protection? The Belgian legal framework governing patents and trademarks is enshrined in Book XI of the Code of Economic Law (CEL). A specific framework for Benelux trademarks is provided by the…
29/04/2021
The key facts about the cannabinoids drugs in Bulgaria. Prepared in association with Kinstellar and PharmDedict, this is an extract from The Pharma Legal Handbook: Bulgaria, available to purchase here for GBP 75. Cannabinoid Drugs 1. Are Cannabinoid Drugs authorized in your country? Pursuant to the Narcotic Substances and Their Precursors Act and secondary legislation for its implementation, Cannabis, as well as Cannabinoid Drugs, are classified in Bulgaria as plants constituting high risk to public health due to the…
06/11/2018
Preclinical and clinical trial requirements in Turkey – a legal guide. 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. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? Clinical trials for drugs are regulated by the Regulation on Clinical Trials of Drugs and Biological Products. Clinical trials for medical devices are regulated…
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…
26/04/2021
An insight into regulatory, pricing and reimbursement overview in the UAE. Prepared in association with STA, an international law firm, this is an extract from The Pharma Legal Handbook: UAE, available to purchase here for GBP 75. 1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? The UAE Ministry of Health (MOH) is the primary authority responsible for oversight of all the regulatory functions concerning pharmaceuticals in the UAE. The Ministry…
14/03/2020
Key legal info on biosimilars & biologics in Croatia. 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. Are biosimilar medicines considered the same as generic medicines in your country? Biosimilar medicines are not the same as generic drugs (a drug that contains the same molecule as an existing non-biological medicine, such as aspirin). Namely, biological medicine, unlike non-biological…
06/05/2021
Key legal info on litigation in Croatia. 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.Who has the burden of proof in litigation for drug side effects? The burden of proof is on the plaintiff, there is no automatism. The parties are obliged to state all the facts on which their claims are based in the lawsuit and the…
01/05/2018
Find out about product liability in Colombian pharma. 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 USD 99. 1. What types of liability are recognized in your jurisdiction? Contractual and extracontractual responsibility under the general principle that anyone causing damages to a given person is liable for those damages. 2. How do these types of liabilities apply to the manufacturers of…
11/10/2018
25/10/2016
20/04/2021
