Legal & Regulatory

Important legal questions related to cannabinoid drugs, medicinal cannabis and opioid drugs 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.   Cannabinoid Drugs 1. Are Cannabinoid Drugs authorized in your country? Yes. We understand Cannabinoid Drugs as psychoactive cannabis for recreational non-medical use, as opposed to Medicinal Cannabis (understood as cannabis used for pharmaceutical purposes), the regulatory framework of which is…

On October 27th, 2019, presidential candidate Alberto Fernández was elected president of Argentina defeating the Macri Administration with more than 48% of votes. The key proposals of Fernández’s political campaign were based on socially-friendly reforms, such as helping the most vulnerable population to progress in the struggling economy, aiding the local industry and blue-collar workers, and ending with the increasing external debt and economic crisis. Another key element to the campaign was his political message promising everyone’s better access to…

The key facts about preclinical and clinical trial requirements in Venezuelan Pharma. Prepared in association with Hoet Pelaez Castillo & Duque (HPCD), a leading law firm in Venezuela, this is an extract from The Pharma Legal Handbook:Venezuela, 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? Yes.   2. How are clinical trials funded? Clinical trials are funded by those interested in obtaining…

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…

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…

Anay Shukla leads the pharmaceutical, life sciences, med-tech and healthcare practice at Nishith Desai Associates, a leading Indian law firm. In this article, he examines the benefit of the recent policy changes to price controls for innovative drugs in India.  Unlike many other countries, India controls prices of all drugs sold in India.   Last month, India announced two key policy changes: First, that all patented new drugs would be exempt from all forms of price control that exist in…

The key requirements for conducting pre-clinical and clinical trials in Greece. 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. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? No. Article 9 par. 3 of Ministerial Decision Δ.ΥΓ3α/Γ.Π. 32221/Government Gazette B 1049/2013, issued in application of Directive 2001/83/EC of the European Parliament and…

All about product liability 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. What types of liability are recognized in your jurisdiction? The Slovak legal order recognizes three types of liability: civil, criminal, and administrative. Civil liability may be further divided into contractual liability, which results from a failure to comply with contractual obligations (e.g. failure to perform…

A legal intro to the situation regarding regulation, pricing and reimbursement 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 are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? The National Organization for Medicines (hereinafter referred to as E.O.F.) which was established in 1983 as a public entity…

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…

Drugs, biologicals and medical devices authorization fees are fixed as part of Finance Law in Algeria. Fees are payable by the person who makes the application or submits variations, in local currency for locally-manufactured products, and in convertible foreign currencies for imported ones.   The supplementary Finance Law for 2020 has just been published in the Official Gazette. Its Article 61 has modified authorization fee due for a new application related to imported and non-essential drugs and biologics.   As…

All legal aspects surrounding preclinical and clinical trial requirements 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. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? There is no such requirement. The Medicines and Allied Substances Control Act only requires that a medicine be registered. In…

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…

An intro to the legal situation for medical cannabis, cannabinoid drugs and opioids in Ecuador. 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.   Cannabinoid Drugs 1. Are Cannabinoid Drugs authorized in your country? On September 17, 2019, the Congress approved the production, commercialization, distribution, use and consumption of cannabis for medicinal or therapeutic uses in the country. lArt. 220 of…

The lowdown on the situation regarding traditional medicines and OTC products in Turkey. 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. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? Traditional herbal medicinal products are pharmaceutical preparations which have specific indications for use, which are specifically administered according to the specified dose and posology,…