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El Salvador Drug Product Registration

Pharmaceutical Product Registration in El Salvador: National Medicine Directorate (Dirección Nacional de Medicamentos - DNM)- Unidad de Registro y Visado

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. 

Compliance with Central American Technical Regulations (RTCA’s)

Apart from the requirements outlined in the Salvadoran Medicine Law, companies must adhere to all Central American Technical Regulations (RTCA’s) related to pharmaceutical products. This includes compliance with Stability Studies for Pharmaceutical Products for Human Use and Labeling for Pharmaceutical Products for Human Use. Ensuring conformity with these regulations is essential for a seamless registration process.

Product Classification and Registration Code

Upon submission of all required documentation, the National Medicine Directorate (DNM) assigns a registration code to the pharmaceutical product. This code comprises a letter indicating the type of pharmaceutical product. The classifications are as follows:

– F: Pharmaceutical

– H: Homeopathic

– N: Natural

– SN: Nutritional supplements

– BT: Biotechnology

– BL: Biological

The letter is followed by the month, day, and year of approval. Any changes to documentation or formulas after approval necessitate additional fees.

Registration Process and Resources

The DNM provides a User’s Guide (Guia de Usuarios Registro) detailing the pharmaceutical product registration process. The application form, available in Spanish, can be accessed [here](http://www.medicamentos.gob.sv/index.php?option=com_phocadownload&view=category&id=6:unidad-de-registro&Itemid=115). Familiarizing oneself with these resources is crucial for a smooth registration process.

Mutual Recognition for Foreign Sanitary Registration

In February 2013, the Salvadoran government approved the decree “Special Regulation for the Mutual Recognition of Foreign Sanitary Registration.” This recognition applies to pharmaceuticals (drugs) with registration from a Sanitary Regulator certified at level IV by the Pan American Health Organization (PAHO) and regulators from the United States, Canada, Australia, Switzerland, Japan, and the Medicine European Agency (EMA).

For biotechnological and biological products, mutual recognition is permitted only if the aforementioned countries have specific regulations for these products. Companies seeking mutual recognition must provide all documentation outlined in Article 20 of the Salvadoran Medicine Law. If the documentation is correct and complete, the DNM will issue a sanitary registration within 10 business days.