According to Bill N° 01668/2021-CR and with the support of the Positive Administrative Silence, the National Authority of Pharmaceutical Products, Medical Devices and Sanitary Products (ANM) must grant, in a term no longer than 45 working days, the sanitary registration to all those drugs included in the category of Rare or Orphan Diseases (ERH) and also those used in oncological treatments.

In spite of being drugs that are submitted to rigorous quality standards and have the approval of countries that exercise a high sanitary vigilance, the procedure in Peru would be extended up to a period of 3 years. The regulation also states that pharmaceutical products, medical devices and health services are exempted from the application of the State Contracting Law (29698) and its regulations through innovative procurement mechanisms for patients with ERH

OMC PHarma Medic is at your disposal, for further information or advice on the subject you can write to us at: omago@omcpharmamedic.com y porlandini@omcpharmamedic.com