Today, in an increasingly globalized world, the international trade of food and dietary supplements is subject to a complex web of regulations and standards. The Southern Common Market, abbreviated in Spanish as Mercosur, is a South American trade bloc comprising Argentina, Brazil, Paraguay, Uruguay, and Venezuela (whose membership has been suspended since 2016). Mercosur plays a vital role in shaping the regulations and standards for food and dietary supplements in the South American region.
The Brazilian Medical Devices market is growing significantly and is expected to reach USD 1.8 billion by 2023. Medical devices in Brazil are regulated by the National Health Surveillance Agency i.e., ANVISA (Agência Nacional de Vigilância Sanitária). Medical devices using functionalities such as Bluetooth, Wi-Fi, Radio Frequency (RF), and other wireless interface require ANATEL certification and homologation as a pre-requisite for ANVISA registration.
Finished drug products contain minute amount of impurities which find their way into drugs at various junctures of manufacturing. They can be residual catalysts from synthesis or might get picked when in contact with manufacturing equipment, containers or other sources. These impurities are generally referred to as ‘Elemental Impurities.’ Their presence in drugs is deemed subject to regulation, as they do not contribute to the ailment and can, at times, lead to potential harm.
Keeping at par with industry trends and following the European Union directives, Turkey has recently introduced a new regulation on packaging, inserts and tracking of pharmaceuticals. On April 25th, 2017, the Turkish Ministry of Health published the Regulation on Packaging Information, Inserts and Tracking of Medicinal Products for Human Use in its Official Gazette.