Marketing Authorization Approval (MAA) for a drug product in Guatemala: How to obtain
If you want to market drug products in Guatemala, you must first obtain a Marketing Authorization Approval (MAA). Scheel Consulting offers this service in Guatemala, as well as in Central America and the Dominican Republic. There are two types of processes:
a) Normal process: Sample and standard submission is required.
b) Process through approval by High Vigilance and Maturity Agencies:** No sample or standard required.
Each project has different characteristics. At Scheel Consulting, we specialize in offering the regulatory strategy that best fits your goals.
In Guatemala, the normal process is as follows:
Preparation of the dossier:
The Scheel Consulting team will provide an updated checklist with the requirements. We will review the documents provided by the manufacturer and offer feedback to complete the dossier.
Sending legal documents, samples, and standards to Guatemala:
Scheel Consulting will confirm the documents required in original. These include the Certificate of Pharmaceutical Product (CPP) or Free Sale Certificate (FSC) and the Power of Attorney, among others.
Technical and legal translations:
All documents submitted to the Authority must be in Spanish. Scheel Consulting provides this service for both technical and legal translations.
Dossier submission:
As of September 2024, this process is carried out in Guatemala in person and on paper.
The Scheel Consulting team submits the dossiers to two entities:
1. The Department of Regulation and Control of Pharmaceutical and Related Products (DRCPFA)
2. The National Health Laboratory (LNS), where the dossier, samples, and standards are submitted.
Each entity evaluates the dossiers independently and issues observations or approvals. The DRCPFA waits for the analysis results issued by the LNS to approve the procedure.
For more information, contact us at info@scheelconsulting.com
