18/07/2019
The low-down on the situation regarding product liability in Spain. Prepared in association with Faus & Moliner Abogados, a leading law firm in Spain, this is an extract from The Pharma Legal Handbook: Spain, available to purchase here for USD 99. 1. What types of liability are recognized in your jurisdiction? The…
15/02/2019
Key information on patents and trademarks 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 basic requirements to obtain patent and trademark protection? Patents Currently,…
02/07/2019
Procedure for renewal of pharmaceutical products in Nicaragua – an overview. 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. RENEWALS OF PRODUCTS THAT HAVE NOT BEEN MARKETED IN NICARAGUA Bill…
25/10/2016
Conducting preclinical or clinical trials in Mexico? Get the legal lowdown here. 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. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? Clinical trials for innovator biological products must take place in Mexico when the product is to be manufactured in Mexico. For products…
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…
14/03/2020
The key facts about orphan drugs & rare diseases 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 is the definition of Rare Diseases in your country? According to Resolution RDC No. 205/2017 issued by the National Health of Surveillance Agency (“ANVISA”), “rare diseases” are defined as diseases with incidence of up to 65…
18/01/2019
A brief overview of the situation regarding marketing, manufacturing, packaging & labeling and advertising within Chinese pharma. 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 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? Please refer to Questions 3 & 6 of the…
29/06/2019
The low-down on the situation regarding cannabinoid drugs, medical cannabis and opioids in Indonesia. 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. Cannabinoid Drugs 1. Are Cannabinoid Drugs authorized in your country? There is no definition of “Cannabinoid” under the Indonesian law. In general, under Law No. 35 of 2009 on Narcotics (“Narcotics Law”), all substances which are categorized under Class 1 Narcotics…
09/08/2019
The legal framework for patents and trademarks 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 are the basic requirements to obtain patent and trademark protection? The Patent Act stipulates that an invention must be novel, non-obvious and have industrial applicability. The Trademark Act allows any trademark unless the mark is the same or similar…
27/06/2019
Preclinical and Clinical Trial Requirements in Croatia – an overview. 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 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 to be conducted locally as a condition for marketing approval. 2. How are clinical trials funded? Clinical…
17/07/2019
An insight into orphan drugs and rare diseases 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. What is the definition of Rare Diseases in your country? Pursuant to Regulation (EC) no. 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products (“Orphan Drug Regulation”), a medicinal product may be designated as…
22/01/2020
All legal aspects surrounding preclinical and clinical trial requirements in Belgium. Prepared in association with ALTIUS, a leading law firm in Belgium, this is an extract from The Pharma Legal Handbook: Belgium, 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 are not required to be conducted locally to receive marketing approval in Belgium. In order to obtain marketing approval, for new drugs,…
06/11/2018
Patents and trademarks in Turkey – an overview. 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 are the basic requirements to obtain patent and trademark protection? Both patents and trademarks are regulated under the Industrial Property Rights Law numbered 6769 entered into force on 10 January 2017 (“IP Law”). Any sign which meets the following can be…
12/10/2018
Traditional medicines & OTC products in South Africa – a legal guide. Prepared in association with Fasken, a leading global law firm, this is an extract from The Pharma Legal Handbook: South Africa, available to purchase here for USD 99. 1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? In terms of the Medicines Act medication is classified into 4 categories from Category A- Category D depending on the In terms of the…
Hot-button legal issues around marketing, manufacturing, packaging & labelling and advertising in Turkish pharma. 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 authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products? Under Turkish laws and regulations, a registration process is required for a drug, biologic medicinal product, over-the-counter medications and…
30/06/2019
The legal framework for regulatory, pricing and reimbursement in Romanian Pharma. Prepared in association with Mușat & Asociații, a leading global law firm, this is an extract from The Pharma Legal Handbook: Romania, 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 regulatory authorities competent in these fields are: the Ministry of Health (http://www.ms.ro/); the National Agency for Medicines and Medical Devices (https://www.anm.ro/);…
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…
28/06/2019
A brief overview of the situation regarding traditional medicines and OTC products 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 are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? The regulatory requirements for traditional and herbal products shall follow the regulations and standards: WHO requirements and guidelines; Good Manufacturing…
23/01/2019
08/11/2018
20/01/2020
