30/05/2020
All about patents & trademarks in Viatnamese 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 are the basic requirements to obtain patent and trademark…
11/06/2020
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…
27/06/2020
The key facts about biosimilars and biologics in Chile. Prepared in association with Carey, a leading global law firm, this is an extract from The Pharma Legal Handbook: Chile, available to purchase here for USD 99. 1. Are biosimilar medicines considered the same as generic medicines in your country?…
05/09/2019
Biosimilars and biologics in Canada: A legal guide. 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. Are biosimilar medicines considered the same as generic medicines in your country? A biosimilar is not a generic biologic product since it is not identical to its reference product; its authorization does not constitute evidence of pharmaceutical equivalence, bioequivalence or clinical equivalence. A biosimilar is a…
28/01/2019
The legal framework for cannabinoid drugs, medical cannabis and opioids 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. Cannabinoid Drugs 1. Are Cannabinoid Drugs authorized in your country? Yes. Cannabinoids can be the active ingredient of a drug product in Canada, provided that such product meets applicable safety, effectiveness and quality requirements under the Food and Drugs Act and its regulations. This…
02/07/2019
The ins and outs of regulatory reforms in Nicaragua. Prepared in association with Bendaña & Bendaña, a leading Nicaraguan law firm, this is an extract from The Pharma Legal Handbook: Nicaragua, available to purchase here for USD 99. 1. Are there proposals for reform or significant change to the healthcare system? No 2. When are they likely to come into force? N/A Click the following links to read more legal articles from Nicaragua: Regulatory Pricing and Reimbursement Overview Preclinical…
09/11/2019
The low-down on the situation regarding cannabinoid drugs, medicinal cannabis and opioid drugs 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. Cannabinoid Drugs 1. Are Cannabinoid Drugs authorized in your country? For the purpose of this chapter, cannabinoid drugs are drugs containing a cannabinoid, which may be extracted and purified from a cannabis plant or synthesized by other…
09/08/2019
All legal aspects surrounding product liability 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 USD 99. 1. What types of liability are recognized in your jurisdiction? Liability under contract and liability under tort law are two basic civil liabilities. The liability under tort law, in principle, requires intention or negligence. However, there is a Product Liability Law, under…
08/10/2019
All legal aspects surrounding product liability 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 types of liability are recognized in your jurisdiction? Violation of laws and regulations may result in civil liabilities, administrative penalties and criminal liabilities Civil Liability discontinuance of infringements; restitution (restoration of original condition); specific performance; compensation for loss; payment for breach of…
Preclinical & clinical trial requirements in Czech Republic – an overview. 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 clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? No, clinical trials may be also conducted abroad. If a clinical trial was conducted in a country outside of…
Cannabinoid drugs, medicinal cannabis and opioid drugs in Russia – a legal guide. 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. Cannabinoid Drugs 1. Are Cannabinoid Drugs authorized in your country? Cannabinoid Drugs are regarded as narcotic drugs of ‘List I’ which circulation within the Russian Federation is prohibited. Cannabinoid Drugs might be imported for scientific and expertise purposes only. 2. What…
23/08/2019
The key facts about traditional medicines and OTC products in Bulgarian Pharma. Prepared in association with Kinstellar, a leading law firm in Bulgaria, this is an extract from The Pharma Legal Handbook: Bulgaria, available to purchase here for USD 99. 1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? Bulgarian law regulates medicinal products and medical devices differently. Medicinal products are grouped in three categories: (i) conventional medicinal products; (ii) traditional herbal medicinal products; and (iii)…
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 USD 99. 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…
23/01/2020
Biosimilars & biologics in Egypt – a legal guide. 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. Are biosimilar medicines considered the same as generic medicines in your country? In Egypt, Biosimilars are considered different from Generic Medicines but similar to biological products, where the “Biosimilar” definition according to the Guidelines for Registration of biosimilar products…
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…
08/02/2019
An intro to the regulatory, pricing and reimbursement scenario for pharmaceuticals 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 are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? Drugs, biological and medical devices are regulated by the Directorate General of Medicines, Supplies and Drugs (known in Spanish as DIGEMID)…
25/10/2016
Key legal info on marketing, manufacturing, packaging & labeling, advertising 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 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? The authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products are…
26/06/2020
26/06/2019
04/12/2020
