Legal & Regulatory > Nicaragua > 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

1. Bill Authorization for sending a sample to file the file
2. 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.
3. Filing of the application of sanitary registration
4. Pre-evaluation
5. Evaluation
6. Acceptance Certificate
7. Issuance of Certificate
8. Approval of invoice to import the product and / or first marketing. This procedure is carried out by the distributor before the Minister of Health.
9. Importation of the product to Nicaragua with the registration number assigned by the Ministry of Health
10. Deposit of the product in the warehouse of the distributor
11. Request for Analysis. The cost of the analysis depends on the number of batches that have been imported of the product.
12. Obtaining samples for the National Laboratory of Quality Control, delivered by the distributor to the Head of the Registry.
13. Approval of Analysis. This result will be delivered by the Ministry of Health to the Registrar.
14. Marketing of the product. The product will be marketed until its analysis is approved; while it is not approved, it cannot be commercialized.