Sponsors of product registrations and importers will benefit from this regulation since it will enable the uninterrupted flow of pharmaceutical products from and to Peru until 2028.
Good Manufacturing Practices (GMP) certificates for pharmaceutical products (including medicines, biologics, and dietary supplements, among others) issued by foreign countries’ national authorities will be accepted as valid by the Peruvian National Regulatory Authority until 2028, provided that interested companies get listed in the pharmaceutical products manufacturers register pending on GMP certification by DIGEMID.
DIGEMID's role
The National Regulatory Authority, through the General Directorate of Medicines, Supplies, and Drugs (DIGEMID, for its acronym in Spanish), conducts the processes of registration of pharmaceutical products, and medical devices. Peruvian NRA demands foreign manufacturers of pharmaceutical products demonstrate compliance with current Good Manufacturing Practices to assure the quality, safety, and efficacy of imported products.
Our NRA is struggling to keep up with the pace of GMP certification applications from local and foreign companies. This new resolution aims to prevent that the current regulation represent an obstacle to commercial activities.
Source: DIGEMID
Learn more about our medical device and pharmaceutical market at 997556699 or by mail [email protected]
Calling Peru from abroad? From North America, please use 011 51 997556699, from Europe, and most APAC countries use 00 51 997556699