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…
30/05/2020
The low-down on the situation regarding product liability in Vietnamese Pharma. 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 types of liability are recognized in…
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…
06/11/2018
Key legal info on regulatory reforms in Uruguay. Prepared in association with FERRERE, a leading law firm in Uruguay, this is an extract from The Pharma Legal Handbook: Uruguay, available to purchase here for USD 99. 1. Are there proposals for reform or significant change to the healthcare system? Currently, a project to reform drugs regulations is being reviewed by the MSP (e.g. expedited proceedings, validity term of authorizations, etc.). 2. When are they likely to come into force? Between…
08/02/2019
Get to know the legal situation around product liability 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 USD 99. 1. What types of liability are recognized in your jurisdiction? Regarding the quality of the pharmaceutical products and medical devices, the responsibility will lie with the manufacturing company when these are made in the country, with the importer holding the Sanitary Registration when…
23/01/2019
A guide to the state-of-play regarding traditional medicines and over-the-counter (OTC) products 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 USD 99, here. 1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? Resolution RDC No. 26/2014 provides for traditional and herbal drugs requirements. These drugs are subject to registration, simplified registration…
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…
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…
The key facts about marketing, manufacturing, packaging & labeling, advertising in Vietnamese Pharma. 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 is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products? PHARMACEUTICAL PRODUCTS Under Vietnamese law, pharmaceutical products or drugs are defined to cover all modern…
22/10/2018
Preclinical and clinical trials in Portugal – a legal guide. 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 clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? No, clinical trials may be conducted abroad. In those cases, and whenever clinical trials are conducted outside the European Union, the applicant of the marketing…
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…
24/10/2018
All about patents and trademarks 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 USD 99. 1. What are the basic requirements to obtain patent and trademark protection? Patents The Russian law provides protection for registered inventions, utility models and industrial designs. Pharmaceutical substance is generally protected as an invention. An invention is a technical solution in any field related to a product (inter…
04/02/2020
A brief overview of the situation regarding patents & trademarks 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 basic requirements to obtain patent and trademark protection? Patent Protection The Patents Act [Chapter 26:03], provides that in order to qualify for patent protection, an invention must consist of patentable subject matter and…
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 USD 99. 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 of…
23/01/2020
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 USD 99. 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…
08/11/2018
A brief overview of the situation regarding regulatory, pricing and reimbursement in Latvia. 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 authorities with jurisdiction over drugs, biologicals, and medical devices in your country? There are several authorities responsible for applying and enforcing the regulatory framework in relation to drugs, biologicals, and medical devices:…
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 USD 99. Orphan Drugs in Panama are regulated by Law 1 January 10, 2001, Executive Decree 40 of May 14, 2019 and Executive Decree 1217 of December 7, 2015; Rare Diseases are regulated by Law 28 of October 28, 2014…
17/07/2019
The ins and outs of regulatory reforms 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 USD 99. 1. Are there proposals for reform or significant change to the healthcare system? Clinical Trial Regulation The aim of the Clinical Trial Regulation is to ensure greater harmonisation of the rules on clinical trials throughout the EU. To this end, it will introduce, i.a.:…
26/06/2019
