20/12/2022
Taken from PharmaBoardroom’s new country-focused series on market access and health technology assessment (HTA), this piece gives the lowdown on the HTA decision analysis framework in Denmark. Buy The Pharma Legal Handbook: Market Access & HTA – Denmark here for £359. Which are the health technology assessment (HTA) evaluation…
19/12/2022
Want to know more about localization 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 119. 1. Are there any rules or regulations requiring and/or encouraging…
10/03/2023
An extract from PharmaBoardroom’s new country-focused series on market access and health technology assessment (HTA), this piece gives the lowdown on price controls and reference pricing systems in Switzerland. Buy The Pharma Legal Handbook: Market Access & HTA – Switzerland here for £359. 1.1 How does price control at…
08/11/2022
The ins and outs of the marketing, manufacturing, packaging & labeling, and advertising 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 GBP 119. 1. What is the authorization process for the marketing of new drugs, biologics, medical devices, non-prescription medications, and other medicinal products? The authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other…
03/05/2022
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 119, 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…
08/07/2019
The key facts about regulatory reforms 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. Are there proposals for reform or significant change to the healthcare system? Currently there are no proposals to change the Law. 2. When are they likely to come into force? It is unlikely that the new law will be approved this year…
27/11/2021
The key facts about localization in the Indonesian pharma market. 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 GBP 99. 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? In principle, MOH Regulation No. 1010/MENKES/PER/XI/2008, as amended by MOH Regulation No. 1020/MENKES/PER/XII/2008 on Drugs Registration, requires that the…
13/10/2022
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 GBP 119. 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…
18/08/2022
The key facts about regulatory reforms in Japanese Pharma. 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 GBP 149. 1. Are there proposals for reform or significant change to the healthcare system? No proposal is pending for significant reform or change to the healthcare system in Japan. However, there are small changes every year. For example, there have been changes…
15/02/2019
All about marketing, manufacturing, packaging & labeling and advertising in Greek pharma. Prepared in association with Calavros Law Firm, a leading global law firm, this is an extract from The Pharma Legal Handbook: Greece, 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? Medicinal Products In line with EU legislation, four different procedures may alternatively be followed in view of obtaining marketing authorization…
10/07/2021
An intro to the legal situation for regulatory, pricing and reimbursement 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 are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? The authorities responsible for applying and enforcing the regulatory framework shall be: concerning drugs and biologicals – the Ministry of Healthcare…
08/11/2021
Introducing the legal situation around marketing, manufacturing, packaging & labelling and advertising of pharmaceuticals in Lithuania. Prepared in association with TGS Baltic, a leading law firm in Lithuania, this is an extract from The Pharma Legal Handbook: Baltics, available to purchase here for GBP 99. 1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products? Possible authorisation procedures for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and…
28/06/2019
An insight into regulatory, pricing, and reimbursement of drugs 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 are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? The pharmaceutical regulatory body in Egypt is the Egyptian Drug Authority (EDA) operating and working under supervision of the Ministry of…
25/05/2020
The ongoing reform of pharmaceutical regulations in Algeria has been marked on January 2020 by publication in the Official Gazette of the long-awaited Decree No 19-379 dated of 31st December 2019. This Decree has laid down procedures for specific administrative, technical and safety control of substances and drugs with psychotropic properties (i.e. including Cannabinoids). The Decree No 19-379 was initially planned to enter into force by 5th of April 2020 according to its Article 41, but considering COVID-19 pandemic…
20/01/2020
A brief overview of the situation regarding biosimilars and biologics. 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. Are biosimilar medicines considered the same as generic medicines in your country? The Health Law No 18-11, dated of 2 July 2018 and published in the Official Gazette, has made a clear distinction between similar biotherapeutic products and generic…
11/10/2018
Upcoming regulatory reforms affecting 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 119. 1. Are there proposals for reform or significant change to the healthcare system? E-pharmacy regulations The Government has recently released draft regulations that propose to create a streamlined system of licensing e-pharmacies and governing the sale of drugs online. The rules grant legal recognition…
Need to know about regulation, pricing and reimbursement in Colombian pharma? Read on! 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 119. 1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? Jurisdiction over drugs, biologicals and medical devices is centralized at the Colombian National Food & Drug Surveillance Institute, better known as INVIMA.…
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…
19/07/2023
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