Cosmetics Registration in El Salvador
Imports, Exports, and Donations Unit of the National Medicine Directorate (DNM)
Link for RA:
Regulations of the Medicines Law of April 2012
Who can register :
- Local legal representative
- Pharmaceutical chemical representative
If necessary, a power of attorney must be in Spanish or translated into Spanish if essential and notarized or apostille.
Data to be communicated :
The DNM requires the following documentation for sanitary registration of cosmetic products:
- Form for Sanitary Registration (which requests information on the product name, manufacturer, importer, legal representative, etc.)
- A Good Manufacturing Practices Certificate from the nation where the manufacturer is located, issued by a regulator or recognised entity.
- Power of attorney on the Legal Representative’s behalf.
- A qualitative full formula supplied by the producer that specifies the quantity of banned chemicals and is signed and approved by the local pharmaceutical chemical representative.
- The manufacturer’s specifications for the finished product
- The item’s original packaging. It is not acceptable to submit a copy. The labels must be written in Spanish.
- Payment receipts for the registration process, which will contain the fees for the various analyses.
Timeframe and fees:
Once all the documents are submitted, the DNM will issue a sanitary certificate within ten business days. All documents should be authenticated or apostille.
The registration is valid for five years.
The registration fee is US$75 per product, and the renewal fee is US$25.
Castilian/Spanish language is required, with translations as necessary. Among the modifications directly addressed by this section is a change of manufacturer, a change of ownership, a formulation change, a change of either the manufacturing company name or the owner’s name, a product name change, the addition of an alternate manufacturing facility, a change in packaging/presentation, adding or removing shade(s), variants or fragrance(s), change/addition/removal of a distributor, and a change of legal representative.