06/11/2018
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…
Key legal info on regulatory reforms 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. 1. Are there proposals for reform or significant change to the healthcare system? Currently, a project to reform drugs regulations is being reviewed by the MSP (e.g. expedited proceedings, validity term of authorizations, etc.). 2. When are they likely to come into force? Between…
An insight into patents and trademarks 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. 1. What are the basic requirements to obtain patent and trademark protection? For trademarks, the basic requirements are novelty, fancifulness and originality. The trademark must be inherently registrable, that is to say, it cannot be descriptive of the goods or services it intends to identify…
The legal framework for product liability 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. 1. What types of liability are recognized in your jurisdiction? Product liability could be attributed to the manufacturer, importer and/or the sales channel (to consumer) and it could be administrative (e.g. regulatory), civil or criminal depending on the defect and the harm caused by the…
The key facts about traditional medicines and OTC products 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. 1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? Regarding medicines and devices please refer to Question 3 in Regulatory, Pricing, and Reimbursement Overview. Decrees 403/016 and 404/016 state that any company undertaking operations with herbal…
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…
Preclinical and clinical trial requirements in Uruguay – a legal guide. 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. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? No. 2. How are clinical trials funded? Clinical trials can be funded by a promoter (individual, company, institution or organization responsible…
A brief overview of the situation regarding regulatory, pricing and reimbursement 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. 1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? The authority responsible for applying and enforcing the regulatory framework in relation to drugs, biologicals and medical devices is the Ministry…
Key legal info on regulatory reforms in Uruguay. Prepared in…
The key facts about traditional medicines and OTC products in…
A brief overview of the situation regarding regulatory, pricing and…
An insight into patents and trademarks in Uruguay. Prepared in…
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