Legal & Regulatory > Nicaragua > Procedure for Renewal of Pharmaceutical Products in Nicaragua

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

1. Bill Authorization for sending a sample to file the application.
2. The reference standard can be sent together with the sample to file the application or send it together with the first import of the product.
3. Filing of the renewal application.
4. Pre-evaluation.
5. Evaluation.
6. Acceptance Certificate.
7. Issuance of Certificate.
8. Approval of invoice to import the product. This procedure is carried out by the distributor before the Minister of Health.
9. Importation of the product in Nicaragua.
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 from 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.

RENEWAL OF PRODUCTS THAT ARE ALREADY TRADED IN NICARAGUA

1. The distributor must deliver a sample to the person responsible for the registration, to file the application.
2. El estándar de referencia puede ser enviando junto con los documentos.
3. Filing of the renewal application.
4. Pre-evaluation.
5. Evaluation.
6. Request for Analysis.
7. Obtaining samples for the National Quality Control Laboratory, delivered by the distributor to the Director of the Registry.
8. Approval of Analysis. This result will be delivered by the Ministry of Health to the Registrar.
9. Acceptance Certificate.
10. Issuance of Certificate.
11. Marketing of the product.