A registration holder (RH) is a business with a local presence in the country you want to market your products. Not all businesses (i.e importers, distributors) are able to manage your registrations, as every country establishes specific requirements to grant a holder license. In Perú, the National Regulator requires registration holders to be licensed as importers and distributors of medical devices, pharmaceutical products or personal care/hygiene products.

Pharma Consulting meets all organizational requirements set by our national regulatory authorities:

If you wish to separate your commercial and regulatory interests in Perú, is not a good idea to appoint a distributor as your in-country representative.

Pharma Consulting highly recommends manufacturers not to allow distributors to perform registrations of products but to allow their authorized representative to take care of the registration process.

This way, your registrations in Perú are under your control. If you decide to end the relationship with your commercial distributor at any point, you would not be required to re-register your products.