Snapshot

The Facilitated Access Law 32319 pathway has been developed by the of Peru.

This pathway can be used where medicines and biological products intended for the treatment of rare diseases, orphans, cancer and other diseases, registered and marketed in countries with high health surveillance.

This pathway accelerates the regulatory review process.

It is an abridged review (a reliance pathway).

When relevant, the agency relies on prior decisions from Austria Belgium Bulgaria Croatia Cyprus Czech Republic Denmark EU-EMA Estonia Finland France Germany Greece Hungary Iceland Ireland Italy Latvia Liechtenstein Lithuania Luxembourg Malta Netherlands Norway Poland Portugal Romania Singapore Slovakia Slovenia South Korea Spain Sweden Switzerland United States

Target time assessment is - The application of the provisions of Articles 10 and 11 of Law 29459, Law on Pharmaceutical Products, Medical Devices and Health Products, is exempted from the application of medicines and biological products intended for the treatment of rare diseases, orphans, cancer and other diseases that are registered and marketed in countries with high health surveillance. - These products are subject to an accelerated evaluation procedure within a period of no more than forty-five calendar days with positive administrative silence, provided that it complies with submitting the complete information on quality, safety and efficacy in the format of the common technical document, the same that was authorized in the country of high sanitary surveillance in English or Spanish, and that includes stability studies in climate zone IV-A or IV-B; as well as the Certificate of Pharmaceutical Product (CPP) or free marketing certificate, which certifies that the same pharmaceutical product is authorized and is being marketed in said PAVS; risk management plan; labels, technical data sheet and insert, in Spanish, and batch release certificate issued by the competent authority of the country of origin in the case of vaccines and plasma derivatives. - The validity and conditions of updating (modifications or changes in the sanitary registration and compliance with specific obligations) in the sanitary registry will be the same as those granted in the PAVS..