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Mrz 27, 2012 (Newsletter Issue 5/12)
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Regulation for Registration of Pharma Products

The regulation for the registration, control and sanitary surveillance of pharmaceutical products, medical devices and sanitary products has been approved through Supreme Decree 016-2011-SA, published in official gazette El Peruano on July 27, 2011.

This norm establishes a new authorization regime that covers medical devices, pharmaceutical products, herbal (plant-based) health products, and dietary, galenic and biological products. It also includes pharmacovigillance and surveillance for medical devices (technovigillance), as well as inspection procedures for the sanitary authorities.
This decree encompasses all the aspects related to the products included in the Peruvian law for Pharmaceutical Products, Medical Devices and Sanitary Products (Law 29459). Its provisions will be implemented by the General Directorate of Medicinal Products, Supplies and Drugs Agency (DIGEMID), depending on the Peruvian Ministry of Health.
Law 29459 repealed Chapter III, part of Title II, of Law 26842 (General Law of Health).
This regulation also addresses the use of trademarks concerning pharmaceutical products.
The norm entered into force on January 27, 2012.

Source: Moeller IP Advisors, Buenos Aires, Argentina