Pharmaceutical Registrations in Nicaragua
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 registration
- Acceptance Certificate
- Issuance of Certificate
- Approval of invoice to import the product and / or first marketing. This procedure is carried out by the distributor before the Minister of Health.
- Importation of the product to Nicaragua with the registration number assigned by the Ministry of Health
- Deposit of the product in the warehouse of the distributor
- Request for Analysis. The cost of the analysis depends on the number of batches that have been imported of the product.
- Obtaining samples for the National Laboratory of Quality Control, delivered by the distributor to the Head of the Registry.
- Approval of Analysis. This result will be delivered by the Ministry of Health to the Registrar.
- Marketing of the product. The product will be marketed until its analysis is approved; while it is not approved, it cannot be commercialized.