Holder Services for Sanitary Registration in Peru

Foreign companies that do not have a presence in the country and wish to market pharmaceutical products, medical devices or health products must have the services of a health registration holder in Peru.

The holder or titleholder is responsible for submitting the sanitary registration applications to the sanitary authority (DIGEMID) and coordinating with them on behalf of their company.

The holder must have a drugstore license, a warehouse certified in Good Storage Practices, an administrative office and a pharmaceutical chemist as technical director.

This company is responsible from the health point of view before the health authorities, and is the one who must have a Quality Management System that guarantees compliance with health regulations in terms of labeling, advertising, storage, release, logistics, traceability, inventory control, as well as the technovigilance and pharmacovigilance unit. This includes a technical manager (pharmaceutical chemist, biologist, doctor or similar) with a professional title acquired in each country respectively.

Aruna Asesores SAC provides local representation services for foreign companies that manufacture or distribute pharmaceutical products, medical devices and health products.