17/09/2021
Read more to find out about patents and trademarks in Colombian pharma. 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 99. 1. What are the basic requirements to obtain patent and…
The key requirements for conducting preclinical and clinical trials in Colombia. 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 99. 1. Are clinical trials required to be conducted locally as a…
Find out about product liability in Colombian pharma. 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 99. 1. What types of liability are recognized in your jurisdiction? Contractual and extracontractual responsibility…
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 GBP 75. 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…
06/11/2018
All about marketing, manufacturing, packaging & labeling and advertising in Uruguayan pharma. 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. 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 Question 3 in Regulatory, Pricing, and Reimbursement Overview. 2. What is the authorization process for the marketing…
28/01/2019
All about product liability 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 USD 99. 1. What types of liability are recognized in your jurisdiction? In general terms, product liability arises from claims in contract or civil wrongs under the common law or civil code, depending on the province. Plaintiffs can hold manufacturers concurrently liable in either contract or civil wrongs. Contractual Liability Plaintiffs…
01/03/2019
The key facts about conducting preclinical and clinical trials in Singapore. Prepared in association with Drew & Napier LLC, this is an extract from The Pharma Legal Handbook: Singapore, 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, there is no such express statutory requirement under Singapore legislation. 2. How are clinical trials funded? Clinical trials may be funded by pharmaceutical companies, hospitals,…
09/11/2019
The key facts about marketing, manufacturing, packaging & labeling, advertising 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 GBP 75. 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 The authorization processes for the marketing of new drugs, biologics, over-the-counter medications, and other medicinal products…
Upcoming regulatory reforms in Singaporean pharma. Prepared in association with Drew & Napier LLC, this is an extract from The Pharma Legal Handbook: Singapore, available to purchase here for USD 99. 1. Are there proposals for reform or significant change to the healthcare system? PROPOSED HEALTHCARE SERVICES BILL Currently, hospitals and private medical clinics are regulated under the Private Hospitals and Medical Clinics Act (PHMCA), which was first enacted in 1980. Since then, there have been significant changes to the healthcare…
07/11/2018
All legal aspects surrounding preclinical and clinical trials in Estonia. Prepared in association with TGS Baltic, a leading law firm in Estonia, this is an extract from The Pharma Legal Handbook: Baltics, 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. Following the national procedure, clinical trials may be conducted…
03/03/2020
On 3 February 2020 the Act of 20 December 2019 amending various legal provisions concerning shortages of medicinal products was published in the Official Gazette. Except for Articles 2 and 4, which entered into force on 31 January 2020, the act’s provisions entered into force on 13 February 2020. In our view, the new legislation does not prevent pharmaceutical companies from applying quotas, provided that they do not affect the public service obligation of wholesaler-distributors (also known as full-line wholesalers. In addition, we…
23/01/2020
The low-down on the situation regarding product liability in Italy. Prepared in association with DLA Piper, a leading law firm in Italy, this is an extract from The Pharma Legal Handbook: Italy, available to purchase here for USD 99. 1. What types of liability are recognized in your jurisdiction? The Italian system recognizes the following types of liability: criminal liability for violation of the Italian Criminal Code; liability for breach of contract according to Article 1218 of the Italian Civil Code; liability…
06/11/2019
The key facts about regulation, pricing and reimbursement in Nigerian Pharma. Prepared in association with Olaniwun Ajayi LP, a leading law firm in Nigeria, this is an extract from The Pharma Legal Handbook: Nigeria, 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 with jurisdiction over drugs, biologicals and medical devices in Nigeria are: (i) The National Agency for Food and…
26/04/2021
The key facts about marketing, manufacturing, packaging & labeling, advertising 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 is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products? Under the Pharmaceutical Law, all applications for marketing authorization must be made through the Ministry of Health (MOH). The authorization…
Preclinical and clinical trial requirements in Turkey – a legal guide. 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. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? Clinical trials for drugs are regulated by the Regulation on Clinical Trials of Drugs and Biological Products. Clinical trials for medical devices are regulated…
30/08/2021
The essential requirements for conducting preclinical and clinical trials 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 99. 1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? No. According to the Technical Guidelines Governing Acceptance of Drug Clinical Data from Foreign Studies issued by the…
28/06/2019
An insight into product liability in Germany. Prepared in association with Heuking Kühn Lüer Wojtek, a leading global law firm, this is an extract from The Pharma Legal Handbook: Germany, available to purchase here for USD 99. 1. What types of liability are recognized in your jurisdiction? Under German law, liability can result from a culpable failure to comply with contractual or quasi-contractual obligations (contractual/quasi-contractual liability), or from a failure to comply with legal obligations which are not at…
An insight about product liability 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 GBP 75. 1. What types of liability are recognized in your jurisdiction? Medicinal product liability arises from the Code of Obligations as tort liability and contractual liability, as well as from the Consumer Protection Law. To claim under tort law, the claimant must prove the existence…
20/04/2021
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