30/05/2020
The legal framework for cannabinoid drugs, medicinal cannabis and opioid drugs 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. Cannabinoid Drugs 1. Are Cannabinoid Drugs authorized in your country? No. 2. What are the regulatory authorities with jurisdiction over Cannabinoid Drugs? The National Unique Registry of Chemicals Operators. Meanwhile, they are…
Keen to learn more about regulatory reforms in Venezuelan Pharma? Read on! 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 there proposals for reform or significant change to the healthcare system? We are not aware of any reform or proposed change within the health system. 2. When are they likely to come…
An insight into patents & trademarks 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. What are the basic requirements to obtain patent and trademark protection? The basic requirements for a patent application consist of: (Art. 59 Industrial Property Law) A. Submit the application and a copy of it to the Autonomous…
29/05/2020
The ins and outs of product liability 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. What types of liability are recognized in your jurisdiction? Civil, criminal and administrative liability. 2. How do these types of liabilities apply to the manufacturers of medicines and devices? The 3 types of responsibilities apply.…
Traditional medicines and OTC products in Venezuelan Pharma – a comprehensive legal overview. 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. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? The Constitution of Venezuela recognizes the practice of traditional medicine in indigenous peoples and communities. Alternative medicine is not…
Key legal info on marketing, manufacturing, packaging & labeling, advertising 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. What is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products? To request the authorization of a clinical protocol of a Pharmaceutical Specialty, the…
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…
All legal aspects surrounding regulatory, pricing and reimbursement 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. What are the Regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? The Regulatory authority is the National Institute of Hygiene. 2. What is the regulatory framework for the authorization,…
The key facts about preclinical and clinical trial requirements in…
Keen to learn more about regulatory reforms in Venezuelan Pharma?…
The ins and outs of product liability in Venezuelan Pharma.…
Traditional medicines and OTC products in Venezuelan Pharma – a…
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