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El Salvador Pharmaceutical Products Registration, special rates

El Salvador Sanitary Registration, Registration of Pharmaceutical Products in El Salvador.

El Salvador Pharmaceutical Products Registration.

 

Procedure Estimated Time: 9-12 months

Special rates

2 to 10 registrations Discount 5% USD 502.94
More than 20 registrations Discount 8% USD 487.06
More than 50registrations Discount del 10% USD 476.47
More than 100 registrations Discount del 15% USD 450.00

LEGISLATION FOR RECOGNITION OF SANITARY REGISTRATION OF MEDICINES IN CENTRAL AMERICA

GUATEMALA, HONDURAS, NICARAGUA AND EL SALVADOR ARE THE COUNTRIES THAT ARE PART OF THE CUSTOMS UNION IN CENTRAL AMERICA. YOU CAN OBTAIN THE MEDICINES REGISTRATION BY MEANS OF THE RECOGNITION OF SANITARY REGISTRATION OF MEDICINES WITHIN THE FRAMEWORK OF CUSTOMS UNION.

The Customs Union has approved the recognition of sanitary registrations for medicines manufactured and registered in Honduras, Nicaragua, El Salvador and Guatemala. Nowadays, it is not necessary to carry out registration process in each country.

Advantages

  • It is a fast process. The cost of the surveillance covers a 5 year period, If the effective period is shorter than 5 years, its cost will be shorter as well.
  • Lab’s analysis cost is saved.
  • Fees for the Chemist Pharmacist are lesser.

Requirements for recognition of Sanitary Registration within the Framework of Customs Union:

  1. Original application for the of recognition of Sanitary Registration, sealed and signed by the responsible Chemist Pharmacist, who has to be native of the country where the recognition will take place.
  2. Power of Attorney duly legalized on behalf of the Chemist Pharmacist. (this power is filed only at one time)
  3. Attested photocopy of Legal Representation. (In Guatemala, Nicaragua and El Salvador = Legal Representative; in Honduras = Commercial Agent.
  4. Original and copy of Unique Form of Certificate of Pharmaceutical Product for marketing within the Customs Union, duly legalized including the quantitative/qualitative formula of the product and the accomplishment of the Good Practice of Manufacture.

Mechanism for recognition of sanitary registration within the framework of customs union:

  1. The responsible Chemist Pharmacist files the established requirements before the sanitary authorities.
  2. Verification of requirements by the sanitary authorities.
  3. The application is resolved by the sanitary authorities within 8 working days.
  4. In case of approval, the sanitary authorities issue a payment order for the sanitary surveillance and recognition.
  5. The responsible Chemist Pharmacist makes the payment for the sanitary surveillance and recognition.
  6. The Unique Form of Certificate of Pharmaceutical Product for marketing within the Customs Union is sealed in original and copy by the sanitary authorities.

The expiration date of the recognition must be the same for the sanitary registration in the country of origin.

COST OF RECOGNITION AND SURVEILLANCE

The professional fees (including the Chemist Pharmacist’s expenses) for the processing is USD 391.43 by product; we can make a substantial discount depending on the number of registrations to be filed.

Additionally, you have to pay for the inspection and surveillance and for the sanitary annuities by product.

The registration can not be recognized in the following cases:

  1. When confusion or similitude of trademarks could exist. In this case, the interested party shall solve his situation. (for instance, the following can be accepted: agreements between companies as long as sanitary risks are not involved, change of trademark or the use of generic name with the manufacturer identification.
  2. When the medicine contains chemical ingredients or mixture of the same that do not have well-documented scientific proof of its security and efficacy.
  3. When the association of chemical components is within the criteria for evaluation of associations to fixed doses not allowed
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