04/07/2019
An insight into regulatory reforms in Bolivian Pharma. Prepared in association with Indacochea & Asociados, a leading Bolivian law firm, this is an extract from The Pharma Legal Handbook: Bolivia, available to purchase here for USD 99. 1. Are there proposals for reform or significant change to the healthcare system? For several years now they have been talking about a new law that will be issued but we don’t expect it to pass any time soon. 2. When are…
12/02/2019
Want to know more about patents and trademarks in Bolivian pharma? Read on! Prepared in association with Indacochea & Asociados, a leading Bolivian law firm, this is an extract from The Pharma Legal Handbook: Bolivia, available to purchase here for USD 99. 1. What are the basic requirements to obtain patent and trademark protection? The formalities to request a trademark registration are: Name and design (if applicable) of the brand International Classification Nice Basic information of the applicant (if the applicant is a…
The ins and out of product liability in Bolivian pharma. Prepared in association with Indacochea & Asociados, a leading Bolivian law firm, this is an extract from The Pharma Legal Handbook: Bolivia, available to purchase here for USD 99 1. What types of liability are recognized in your jurisdiction? Civil liability occurs when an individual or a legal entity causes harm to another. Given the event, the aggrieved party must claim the reparations for the compensatory damages caused. The complaint must be…
Bolivian regulation regarding traditional medicines and OTC products. Prepared in association with Indacochea & Asociados, a leading Bolivian law firm, this is an extract from The Pharma Legal Handbook: Bolivia, available to purchase here for USD 99 1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? Products must contain vegetal, mineral or animal components in order for them to be classified as “traditional, herbal, complementary or alternative medicines”. 2. Can these traditional, herbal, complementary, or…
All you need to know about Marketing, Manufacturing, Packaging & Labeling, Advertising in Bolivian pharma. Prepared in association with Indacochea & Asociados, a leading Bolivian law firm, this is an extract from The Pharma Legal Handbook: Bolivia, available to purchase here for USD 99. 1. What is the authorization process for the marketing of new drugs, biologics, medical devices, non-prescription medications, and other medicinal products? The first step in order to obtain the corresponding authorization to commercialize products in Bolivia is to…
Preclinical and Clinical Trials in Bolivia – an overview. Prepared in association with Indacochea & Asociados, a leading Bolivian law firm, this is an extract from The Pharma Legal Handbook: Bolivia, 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, it’s not a set condition. Studies issued by other countries are accepted. 2. How are clinical trials funded? The interested party is responsible for…
An overview of the regulation, pricing and reimbursement of drugs in Bolivia. Prepared in association with Indacochea & Asociados, a leading Bolivian law firm, this is an extract from The Pharma Legal Handbook: Bolivia, available to purchase here for USD 99. 1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? In Bolivia the authority that regulates all matters is the State Agency for Medical Products and Health Technology (Agencia Estatal de Medicamentos y…
An overview of the regulation, pricing and reimbursement of drugs…
Preclinical and Clinical Trials in Bolivia – an overview. Prepared…
Bolivian regulation regarding traditional medicines and OTC products. Prepared in…
All you need to know about Marketing, Manufacturing, Packaging &…
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