04
Regulatory
Representation
(holder)
¿What is a sanitary registration holder?
A holder or sanitary registration holder (RH) is a locally established company in the country where the products are to be marketed. Not all companies (e.g., distributors) are qualified to manage these registrations, as each country sets specific requirements for granting holder licenses. In Peru, the Regulatory Authority requires that the holder have authorization to import, store, and distribute medical devices, pharmaceutical products, and cosmetic products.
Seven & Eleven does not recommend that manufacturers allow their distributors to manage product registrations. Instead, manufacturers should assign this responsibility to their authorized representative in Peru.
This way, your registrations in Peru remain under your control. If you decide to terminate commercial relationships with distributors at any time, you will not need to re-register your products.
Regulatory Representation (holder) >
Pharma Consulting Representation Tasks
To maintain permanent contact with official organizations, in order to prepare the technical dossier for sanitary registration authorization for Registration, Re-Registrations, Response to Notifications, changes and/or updates in the sanitary registration of pharmaceutical products or medical devices, in accordance with current administrative technical procedures and/or current regulations.
- To keep updated the status (virtual and physical) of submitted dossiers for Registration, Re-Registrations, Response to Notifications, changes and/or updates in the sanitary registration of pharmaceutical products or medical devices.
- To stay informed about regulatory updates that may affect the development of products with sanitary registration.
- To carry out pharmacovigilance, technovigilance and cosmetovigilance activities.





Dirección: Calle José Toribio polo 260, oficina 201, Miraflores. Lima, Peru.

