Snapshot

The Conditional Sanitary Registration of Medicines and Biological Products pathway has been developed by the Dirección General de Medicamentos, Insumos y Drogas (DIGEMID) of Peru.

This pathway can be used where The conditional sanitary registration is granted to medicines and biological products with clinical studies in phase III with preliminary results, in the prevention and treatment of seriously debilitating or life-threatening diseases, which give rise to a declared emergency due to risks or damage to public health, recognized by the Executive Power or by the WHO. The conditional sanitary registration of a medicine or biological product authorizes its manufacture, import, storage, distribution, commercialization, dispensing, sale or use. The conditions under which the conditional sanitary registration is authorized must be maintained during its validity..

This pathway accelerates the regulatory review process.

It is an abridged review (a reliance pathway).

When relevant, the agency relies on prior decisions from EU-EMA WHO

The ANM, within a period of no more than ninety (90) calendar days from the receipt of the request, approves or denies the request for registration or re-registration in the conditional sanitary registration. The application evaluation period is up to thirty (30) calendar days, when the product is approved in the European Medicines Agency (EMA) or in the High Health Surveillance Countries; or they have been prequalified by WHO; and the reports of the evaluation analysis for the authorization of the product in said Agencies are available; and the company has submitted all the documentation in accordance with the provisions of this Regulation, which supports the quality, safety and efficacy with which they were authorized by the aforementioned Agencies. *High surveillance countries are those established in the Regulation for the Registration, Control and Sanitary Surveillance of Pharmaceutical Products, Medical Devices and Sanitary Products, approved by Supreme Decree No. 016-2011-SA and amendments.