Application of Foreign Pharmaceutical Sanitary Registration, Sanitary Registration El Salvador.
In El Salvador, the competent health authorities officially recognize medical records provided by health authorities in countries where drug regulatory agencies have been certified to Level IV by the Pan American Health Organization (OPS in Spanish), as well as those granted health records by health authorities in the United States, Canada, Australia, Switzerland, Japan and the European Medicines Agency (EMA)
The recognition applies to all drugs that have been registered by the countries mentioned in the preceding paragraph. However, biotech drugs, or biosimilars and biologics, will be awarded the appropriate register, provided they have been recorded by these countries and that these countries have specific regulations for these.
The requirements for the application of foreign pharmaceutical sanitary registration are:
- Special POA for sanitary registration, authenticated to the El Salvador Consulate or Apostille. We provide the model once it is accepted our offer of professional services..
- Certificate of Free Sale (CVL) which includes the good manufacturing practices. (Authenticated the consulate of El Salvador or Apostille) recent date, since its effect in El Salvador is 2 years from the date of issue to appear in the document.
- Certification of Good Manufacturing Practices, only in the case of not including the Certificate of Free Sale (Authenticated the consulate of El Salvador or Apostille)
- Original of the Qualitative and Quantitative Formula document, signed by the responsible. Expressed in SI units, in the case that the formulation contains plant species should be declared the scientific name of the plant used. (It mustn’t be qualitative) It must be identical to that expressed in the CVL.
- Analysis Method Finished product.
- Certificate of Analysis Finished original signature and stamp of the responsible for the lot number to submit samples.
- Packaging sample project (primary or scheme including details of how many units are for blister and secondary) as will be marketed in Spanish Language. The label must contain: product information; formula per dosage unit, registration number, date of manufacture and expiration, or date by which the product should be consumed. It must include sales mode and administration among others.
- Stability study, noting next:
- 40 ° C ± 2 ° C, 75% ± 5% RH (ACCELERATED)
- 30 ° C ± 2 ° C, 65% ± 5% RH (NORMAL)
- Samples of the products, the effect will be not less than six months at the time of submission, so we recommend that you send at least one year in duration.
- Working Standard or active in an amount not less than 1 gram and its corresponding certificate of analysis. The force shall be not less than 1 year at the time of submission.
- Chromatograms or batch absorption spectra of the samples to submit to registration (photocopies)
- Drug Information and Literature (Prescribing Information)
- Monograph active chemistry.
Our rate for the recognition of medical records estrange is USD 535.00 plus the official fees for registration and laboratory tests internal and external, that through the registration process, the Salvadoran National Medicine Office, which provides the type and analysis costs.