El Salvador Drug Product Registration

In the vibrant pharmaceutical landscape of El Salvador, adherence to the regulatory framework is paramount for companies aiming to introduce their products into the market. The process is governed by the National Medicine Directorate (Dirección Nacional de Medicamentos – DNM), and U.S. companies looking to register their pharmaceutical products must navigate a structured set of requirements and procedures.

Legal Representation and Documentation

For a seamless entry into the Salvadoran market, U.S. companies must appoint a local legal representative or importer, along with a pharmaceutical chemical representative. A crucial requirement is a Power of Attorney, which must be drafted in Spanish, notarized, or apostilled.

Article 20 Compliance: Essential Documents

The Salvadoran Medicine Law, specifically Article 20, outlines the requisite documents for pharmaceutical product registration. These documents include:

1. Application Form: Accompanied by a Power of Attorney if signed by the local representative.
2. Power of Attorney or Document Naming the Representative: Original or certified copy.
3. Certificate of Pharmaceutical Products: Aligned with World Health Organization (WHO) standards. In its absence, a Certificate of Free Sale from the country of origin, or a Certificate of Good Manufacturing Practices, is required.
4. Formulas: Qualitative and quantitative formulas, included in the Certificate of Free Sale if applicable.
5. Product Analysis Certificate: Issued by the manufacturer’s quality control laboratory.
6. Stability Study: For climate zone IV, signed by the responsible pharmacist or assigned technical professional.
7. External Analysis Certificate: Original and copy.
8. Chemical Monograph: For active principles or pharmacognosic monograph for natural products.
9. Packaging Labeling: Primary and secondary packaging, as intended for sale in the country.
10. Additional Technical Scientific Information: As required by the Regulatory entity.
11. Method of Analysis: Validated method for analyzing the finished product.
12. Sample of Inserts: Any insert, prospect, or instructive, when necessary.
13. Pharmacology Information: Details about the finished product’s pharmacology.
14. Registration Fee Payment Receipt: Proof of payment for the registration fee.

Registration Process and Timeline

The Registry and Certification Unit (Unidad de Registro y Visado) of the DNM handles the registration process. The foreign pharmaceutical product registration fee is $500, and the processing time ranges from 3 to 6 months. The registration remains valid for five years, after which renewal is possible with a fee of $86.

Financial Obligations for Local Importers

Local importers of foreign pharmaceutical products must be aware of financial obligations beyond the registration process. An importer license fee of US$86 and an annual sales license of US$75 are mandatory. All documentation, a crucial aspect of the registration process, must be submitted in Spanish and carry an Apostille. Additionally, the number of samples required depends on the specific product.