El Salvador Pharmaceutical Products Registration, El Salvador Registration
The requirements for the application of pharmaceutical products registration are:
- Power of attorney for sanitary registration, authenticated whether the consulate of El Salvador or Apostille. We provide the model of Power of attorney whether accepted our offer of service.
- Certificate of Free Sale (CFS) which includes the good manufacturing practices. Authenticated whether the consulate of El Salvador or by Apostille) with recent date, because its effect in El Salvador is 2 years from the date of issue that appears in the document.
- Certification of good manufacturing practices, just if have not been included in the certificate of free sale (Authenticated whether the consulate of El Salvador or by Apostille)
- Original Quali-Quantitative formula, signed by the responsible. Expressed in International System of Units, in the case that the formulation contains plant species, must be declared the scientific name and the part of the plant used. (Not to be qualitative) Must be identical to the expressed in the Certificate of Free Sale (CFS).
- Analysis Method of Finished Product, which must include the requirement of VALIDATION, authenticated whether the consulate of El Salvador or Apostille.
- Certificate of analysis of original finished product with signature and seal of the responsible; corresponding to the number of lot of the samples to submit.
- Packaging Project (primary including details or scheme of how many units are in blister and secondary) as it will be commercialized, in Spanish Idiom. 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, considering the following data.
- 40°C ± 2°C; 75 % ± 5% RH (ACCELERATED)
- 30°C ± 2°C; 65 % ± 5% RH (NORMAL)
- Samples of the products, the validity shall not be less than 6 months at the time of submission, so it is recommended to be sent at least one year of validity.
- Standard work of the active or actives in an amount not less than 1 gram and its corresponding certificate of analysis. The duration shall be not less than 1 year at the time of submission.
- Chromatograms or absorption spectra of the lot of samples to submit to registration (photocopies)
- Pharmacological information and literature (prescription information)
- Chemical monograph of the active principle
Our fee for Pharmaceutical Product Registration is USD 615.00, plus official rates for registration and examination of internal and external laboratories, that during the process of registration, the Public Health Council order, entity that provides the type of analysis and the value of this.