El Salvador Pharmaceutical Products Registration, El Salvador Registration
The requirements for the application of pharmaceutical product registration in El Salvador are:
-
- Power of attorney for sanitary registration, authenticated either through the consulate of El Salvador or Apostille. We provide the model of Power of attorney whether accepted our offer of service.
- Recently issued free sale certificated, which includes the good manufacturing practices. Authenticated either through the consulate of El Salvador or by Apostille. Because its validity in El Salvador is 2 years starting from the date of issue that appears in the document.
- Certification of good manufacturing practices, if it has not been included in the certificate of free sale, authenticated either through the consulate of El Salvador or by apostille.
- Original Quali-Quantitative formula, signed by the responsible party. Expressed in International System of Units, in the case that the formulation contains plant species, the scientific name of the plant, its name and the part of the plant used must be declared. (Not to be qualitative) it must be identical to the one expressed in the Certificate of Free Sale (CFS).
- Finished Product Analysis Method (Test Method), including VALIDATION.
- Original finished product Certificate of Analysis with the signature and seal of the responsible party; corresponding to the batch number of the samples to be submitted.
- Primary and secondary packaging projects in Spanish (for the primary package the detail or scheme of how many units are per blister must be included) the way it will be commercialized in El Salvador. The tag must contain: the information of the product; formula per unit or doses, number of inscription, date of manufacturing and expiration, or final date for the product to be consumed. Selling mode and route of administration etc.
- Stability study data and protocol both signed and sealed by the responsible parties, conducted for climatic zone IV conditions.
- Chromatograms or absorption spectrum from the sample batch to be submitted.
- Pharmacological information and literature. (Insert / prospect).
- Active ingredient chemical monography.
- Bibliography.
- Relevant information that the patient must know for the appropriate product use.
- Clinical studies, if required by authorities.
Professional Fees:
Our fee for Pharmaceutical Product Registration is USD 615.00, plus official rates for registration and examination of internal and external laboratories, required by the National Drug Bureau, which is the authority that determines the type of analysis and its cost, during the process of registration.