Registration of Pharmaceutical Products in El Salvador.

Procedure Estimated Time: 9-12 months

Special rates

SANITARY REGISTRATION RECOGNITION OF PHARMCEUTICAL PRODUCTS  IN CENTRAL AMERICA

 THE CENTRAL AMERICAN COUNTRIES THAT BELONG TO THE CUSTOMS UNION (GUATEMALA, HONDURAS, NICARAGUA AND EL SALVADOR), CAN OBTAIN THE REGISTRATION OF PHARMACEUTICAL PRODUCTS THROUGH THE RECOGNITION OF THE SANITARY REGISTRY FROM ITS COUNTRY OF ORIGIN.

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

Advantages

• It is a faster process, the cost of the surveillance covers a period of 5 years, if the surveillance period is less than 5 years, the cost will be less as well.
• There is no need to pay for laboratory analysis.
• The fees for the Chemist are lower.

Requirements for recognition of sanitary registration within the framework  of the Customs Union:    

1. Original application for the of recognition of sanitary registration, sealed and signed by the responsible professional, who must be from the country where the recognition is requested.
2. Duly legalized Power of Attorney granted to the Chemist. (This Power of Attorney is filed only once).
3. Attested copy of legal representation. In Guatemala, Nicaragua and El Salvador known as Representante Legal and in Honduras as Representante Comercial.
4. Duly legalized original and copy of the Pharmaceutical product unique format certificate for sales within The Customs Union which must include the quali-quantitative formula of the product and the good manufacturing practice certificate.

Recognizement procedure for the sanitary registration within the framework of the Customs Union:

1. The responsible Chemist files the established requirements before the sanitary authorities.
2. The sanitary authorities verify the filed requirements.
3. The sanitary authorities solve the application within the next 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 makes the payment for the sanitary surveillance and recognition.
6. The sanitary authorities seal the original and copy of the unique format certificate for sales within The Customs Union.

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

COST OF RECOGNITION AND SURVEILLANCE

The fees (including the Chemist's fees) for the service are USD 391.43 by product, from which we can make a substantial discount depending on the number of recognitions to be filed.

In addition, it is necessary to pay the official fees for recognition and sanitary surveillance for each product, with an approximate cost of USD 330.00.

The sanitary registry cannot be recognized in the following cases:

1. Whenever there is a similar trademark that may cause confusion. In such case the interested party shall solve this situation. (As examples of this, agreements between companies are acceptable, as long as there are no sanitary risks involved, trademark change or the use of a generic name with the manufacturer identification).
2. When the product contains active ingredients or a mixture of the same that do not have well-documented scientific proof of its safety and effectiveness.
3. When the active ingredient association, is within the evaluation criteria of the unallowed fixed-dose association.