17/09/2021
The key facts about biosimilars and biologics 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. Are biosimilar medicines considered the same as generic medicines in your country?…
A structured legal guide to marketing, manufacturing, packaging & labelling and advertising 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 GBP 99. 1. What is the authorization process for…
All legal aspects surrounding cannabinoid drugs, medicinal cannabis and opioid drugs in Colombia. Prepared in association with Cavelier Abogados, a leading law firm in Colombia, this is an extract from The Pharma Legal Handbook: Colombia, available to purchase here for GBP 99. Cannabinoid Drugs 1. Are Cannabinoid Drugs authorized in…
23/01/2019
An overview of the legal framework for patents and trademarks for pharmaceuticals 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 are the basic requirements to obtain patent and trademark protection? Industrial Property Rights are regulated in Brazil through Federal Law No. 9,279/1996 (“IP Law”). Under its Article 8, the main requirements for the grant…
10/05/2021
The COVID-19 pandemic has caused economic and social disruption and affected the behaviour of both consumers and producers in Argentina, with an important impact on Argentine currency (ARS) devaluation and inflation, among others. We are not yet able to measure the real impact of the uncertainty the world is currently facing and its impact on the country. In December 2019, President Macri ended his term and Alberto Fernandez took office with Cristina Kirchner as vice president, after having promised…
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 GBP 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 with the National Institute of Industrial Property (the “INPI” after its acronym in Spanish). The…
29/06/2019
Patents and trademarks in Indonesia – a comprehensive legal overview. 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 basic requirements to obtain patent and trademark protection? In order to obtain patent or trademark protection, the applicant must register them with the Directorate General of Intellectual Property (“DGIP”). Trademark registrations are valid for 10 years and may be extended for…
23/01/2020
An insight into biosimilars & biologics 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 biosimilar medicines considered the same as generic medicines in your country? Biosimilar medicines are not regulated in the same manner as generic medicines in India. While biosimilars and generic medicines are classified as drugs under the Drugs…
31/01/2020
Keen to learn more about cannabinoid drugs, medicinal cannabis and opioid drugs in Japan? Read on! 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. Cannabinoid Drugs 1. Are Cannabinoid Drugs authorized in your country? No. In Japan, usage of cannabis (all kinds) is severely restricted by two acts. The first is the Cannabis Control Act, under which “Cannabis” is…
20/04/2021
All about marketing, manufacturing, packaging & labeling, advertising in Polish Pharma. 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 authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products? a) Medicinal products Chapter 2 of the Pharmaceutical Law sets forth the rules relating to the marketing of…
27/06/2019
An insight into upcoming regulatory reforms affecting Croatia pharma. 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 there proposals for reform or significant change to the healthcare system? Bill of Ordinance on benchmarks for the classification of medicinal products on basic and additional list of medicinal products of the Croatian Health Insurance Fund and on benchmarks on…
12/04/2021
The legal framework for localization in 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. 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 generally not such rules. However, the handling with medicinal products (as defined by the Act on Medicinal…
28/06/2019
An intro to the legal situation for regulatory reforms 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. Are there proposals for reform or significant change to the healthcare system? No, but the Comprehensive Health Insurance Scheme Law No. 2 of the year 2018 was issued on 11th of January 2018 and its Executive Regulations…
04/02/2020
The key facts about regulatory, pricing and reimbursement overview in Zimbabwe. Prepared in association with Honey & Blanckenberg, a leading law firm in Zimbabwe, this is an extract from The Pharma Legal Handbook: Zimbabwe, 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 Medicines Control Authority of Zimbabwe (MCAZ) is the authority tasked with regulation of drugs and medical devices in Zimbabwe. It…
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 competitive advantages, including low cost of energy, skilled and inexpensive workforce, and geographic location at the crossroads of Europe, Africa, and the Middle East, FDI flows into Algeria have remained…
08/10/2019
A brief overview of the situation regarding traditional medicines and OTC products in Malaysian Pharma. Prepared in association with Skrine, a leading law firm in Malaysia, this is an extract from The Pharma Legal Handbook: Malaysia, available to purchase here for USD 99. 1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? Alternative medicine is regulated by the Traditional and Complementary Medicine Council (“TCM Council”) established under the Traditional and Complementary Medicine Act 2016 (“TCMA…
08/11/2018
All you need to know about traditional medicines and OTC products in Latvian pharma. Prepared in association with TGS Baltic, a leading law firm in Latvia, this is an extract from The Pharma Legal Handbook: Baltics, available to purchase here for USD 99. 1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? Traditional herbal medicinal products are regulated by the PL and its regulations. Traditional herbal medicinal products may receive a marketing authorization following a…
06/11/2019
All legal aspects surrounding preclinical and clinical trial requirements in Nigerian Pharma. 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. 1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? Clinical trials are not required in all cases, clinical trials will be required to be conducted as a condition for marketing approval…
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