Sanitary Registration in El Salvador.


Requirements to start the registration process and / or renewal of food and beverage products:

1.

Power of attorney for sanitary registration, authenticated whether the consulate of El Salvador or Apostille.

2.

Certificate of Free Sale (CFS) which includes the good manufacturing practices. Authenticated whether the consulate of El Salvador or by Apostille) with recent date.

Propiedad Intelectual en El Salvador

Requirements for Registration of Pharmaceuticals in El Salvador
 

The requirements for the application of pharmaceutical sanitary registration are:

1.

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.

2.

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.

3.

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).

4.

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).

5.

Analysis Method of Finished Product, which must include the requirement of VALIDATION, authenticated whether the consulate of El Salvador or Apostille.

6.

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.

7.

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.

Estudio de Estabilidad, tomando en cuenta los datos siguientes:

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.

Professional Fee:

Our professional fee for Product Registration is USD 475.00, plus official rates for registration and examination of internal and external laboratories, that during the process of registration, the National Medicine Office of El Salvador request, entity that provides the type of analysis and the value of this.

Requirements for Sanitary records cosmetics in El Salvador:
 

1.

Power of attorney for sanitary registration, authenticated whether the consulate of El Salvador or Apostille, according to the model, that we will provide in case our offer whether accepted.

2.

Certificate of Free Sale (CFS) which includes the good manufacturing practices. Authenticated whether the consulate of El Salvador or by Apostille) with recent date.

3.

Original Quali-Quantitative issued by the manufacturer and supported with signature and stamp of responsible professional.

4.

Specifications of finished products, issued by the manufacturer laboratory.

5.

Authorization document for distribution in El Salvador, granted by the manufacturer for the distributor.

6.

If the product is manufactured by third parties, add subcontracting agreement, authenticated whether the consulate of El Salvador or Apostille.

7.

Samples of Packaging, as will be commercialized.

8.

Permission of importer from the Cosmetic Products Distribution Company.

Professional Fee:

Our professional fee for Product Registration is USD 475.00, plus official rates for registration and examination of internal and external laboratories, that during the process of registration, the National Medicine Office of El Salvador request, entity that provides the type of analysis and the value of this.