Legal & Regulatory > Nicaragua

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…

The legal framework for patents and trademarks 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. What are the basic requirements to obtain patent and trademark protection? Power of Attorney, duly legalized by Apostille For patents, all data related to the priority or PCT application, as well as a copy of the specification and claims in Spanish For…

All legal aspects surrounding product liability 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. What types of liability are recognized in your jurisdiction? Civil Liability Criminal liability   2. How do these types of liabilities apply to the manufacturers of medicines and devices? It must be shown that human health has been affected as a consequence of…

An insight into traditional medicines and OTC products 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. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? Find attach a document with drugs Requirements. Find attachment document with Device Requirements.   2. Can these traditional, herbal, complementary, or alternative products be advertised directly to…

The key facts about marketing, manufacturing, packaging & labeling, advertising 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. What is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products? Have a distributor authorized by the Ministry of Health that has a valid health license. Grant power to a…

A brief overview of the situation regarding preclinical & clinical trial requirements 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 clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? It is not a requirement that they be done locally.   2. How are clinical trials funded? The Manufacturer Laboratory…

All you need to know about regulation, pricing and reimbursement in Nicaraguan pharma. 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. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? The National Health Regulation Authority (ANRS) has been created, which is the competent body of the Ministry of Health, which will…

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 GBP 75   RENEWALS OF PRODUCTS THAT HAVE NOT BEEN MARKETED IN NICARAGUA Bill Authorization for sending a sample to file the application. The reference standard can be sent together with the sample to file the application or send it together with the first…

All of the requirements for Pharmaceutical Regulatory Affairs 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.   According to the RTCA, subsection 7. The requirements for sanitary registration are the following: 1. Power of attorney to the legal representative duly legalized or apostilled. We attach format. 2. Copy of the acknowledgment of receipt of the distribution power or contract…

All about pharmaceutical registrations 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.   REGISTRATION OF NEW PRODUCTS Bill Authorization for sending a sample to file the file The reference standard can be sent together with the sample to file the file or send it together with the first importation of the product. Filing of the application of sanitary…

All of the Requirements for the Sanitary Registration of Medical Devices 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.   CLASS I. LOW RISK: Sanitary license of the establishment, issued by the Directorate of Registration of Medical Devices of the Ministry of Health. Free sale certificate that demonstrates its use in the country of origin. Certificate of Good Manufacturing…