Snapshot

The Special Regulations for the Recognition of Foreign Health Registrations. pathway has been developed by the National Medicine Directorate (Dirección Nacional de Medicamentos- DNM) of El Salvador.

This pathway can be used where all therapeutic products..

It is a verification review (a recognition pathway).

When relevant, the agency relies on prior decisions from Australia Canada EU-EMA Japan Switzerland United States

The procedure for providing the sanitary registration of pharmaceutical products, taking into account the knowledge of foreign sanitary registrations, shall be as follows: 1. Submit the application with the requirements and documents established in Article 20 of the General Regulations of the Medicines Law. 2. Once the application and other requirements have been submitted, a technical documentary analysis of the same will be carried out, for which the Directorate will have ten (10) working days, following the receipt of the application. 3. If observations are found from the technical analysis, the interested party will be notified only once. The notification must be withdrawn from the offices of the Directorate by the applicant or by the person who has his written authorization: 4. The applicant shall have a period of eight (8) working days, counted from the date of notification, to correct the observations relating to the application and its annexes. If within the term indicated above, the applicant does not do so or does so improperly, the Directorate, within five (5) business days from the date of presentation of the document or the expiration of the term indicated, as the case may be, shall declare the application expired and notify the applicant to withdraw the documentation within fifteen (15) days following the notification of said administrative act. If the applicant does not withdraw it; it will be archived. 5. If the technical documentary information is favorable, the Directorate, within a maximum of ten (10) working days from the receipt of the application and other requirements indicated in the supplementary articles, will automatically assign the sanitary registration number and will grant the respective Sanitary Registration Certificate with recognition of the foreign Sanitary Registry using the format determined for this purpose by the respective Registration Unit.