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
Emergency decree No. 0-26-2020 established various exceptional and temporary measures to prevent the spread of the new coronavirus (COVID-19) in Perú. Our national regulator, DIGEMID, has established the prioritization of several administrative procedures: • Exceptional authorizations for individual treatment of patients, which grants the bearer authorization to import medicines, biological products, and medical devices. •
Estimates of the Peruvian Cosmetic and Hygiene Guild (COPECOH) indicate that the market for personal hygiene and cosmetic products would mobilize up to 9.8 billion soles during this year. The products with the greatest demand, mainly by women, are fragrances, hair products, skincare products, and makeup. In terms of consumer channels for these products, the
The National Authority of Pharmaceutical Products, Medical Devices, and Health Products has reduced the maximum period of evaluation for the inscription and reinscription of medical devices in the Peruvian sanitary registry. Medical Devices (MD) Class I, low risk: Up to thirty (30) calendar days. Medical Devices (MD) Class II, moderate risk: Up to sixty (60)
The president of the Pharmaceutical Industries Association (ADIFAN), José Silva, explained that Peruvian laboratories are at disadvantage compared to foreign manufacturers who are favored by tariff exemptions. Due to this situation, Peruvian laboratories manufacture less quantity of medicines, causing up to 70% of medicines in Perú to be imported and only the remaining 30% to
Pharma Consulting warns the general public about the danger of acquiring pharmaceutical products, medical devices, and other health products in unauthorized establishments or through advertisements on social networks and e-commerce websites. We express our concern about an increase in advertisements for products that lack the registration required, advertisements that proclaim unauthorized benefits, or therapeutic properties
The Directorate of Medicines, Supplies, and Drugs - DIGEMID, issued a list of medical devices that can be marketed directly to end-users. In order to acquire a particular product, users must present a medical prescription, if required. Biomedical Equipment Class I (low risk), class II (moderate risk), class III (high risk), and class IV (critical