SÃO PAULO and LONDON, November 24, 2015 /PRNewswire/ --
R&B Rastreabilidade Brasil SA, the Brazilian leader in track and trace solutions, and Aegate, the world's leading provider of medicines authentication services, have formed an alliance with the aim of providing a comprehensive service to both fulfil the requirements for the ANVISA service as well as launching medicine authentication in Brazil.
This alliance brings together two market-leading companies with the shared goal of achieving better patient safety. R&B Rastreabilidade Brasil S.A. is the leading track and trace company in Brazil and has developed a proprietary solution that supports manufacturers, importers, distributors, hospitals, primary and secondary care pharmacies and other members of the distribution chain to be in compliance with the local Track and Trace legislation. Aegate has more than a decade of experience, and is the first and only medicines authentication provider to provide a live service to more than 24,000 dispensing points in 12 countries in Europe, and the only validated authentication hospital service live today at the Oxford University Hospital in the UK.
As a demonstration of its commitment to the Brazilian market, Aegate will establish a Brazilian business unit in alliance with R&B Rastreabilidade Brasil. The sharing of expertise between Aegate and R&B Rastreabilidade Brasil will enable the swift achievement of national legal compliance to medicine authentication standards within the mandated Brazilian adoption period.
Mark De Simone, CEO of Aegate said: "Aegate is committed to supporting the health of Brazilian citizens, and patients throughout South America. This exciting alliance with R&B Rastreabilidade Brasil is one of unprecedented synergy and impact, and complements Aegate's activities in North America in response to the Drug Safety and Quality Act (DQSA). Aegate is confident that its expertise in technology, operation and implementation offers extraordinary value to all stakeholders in the healthcare value chain that will ultimately reduce cost, increase profitability and, above all, safeguard patient safety."
Amilcar Lopes, CEO of R&B Rastreabilidade Brasil said: "R&B Rastreabilidade Brasil, has been collaborating with leading academic, public and private hospitals in Brazil to improve the understanding of the RDC 54 and the track and trace process in the country. The alliance with Aegate will bring greater security to the patient through the authentication process already used by Aegate in Europe. We are ready to act on this important synergy for medicinal products in South America and globally."
Aegate and R&B Rastreabilidade Brasil will make further announcements to inform all stakeholders of their next steps together.
NOTES TO EDITORS
In 2014, 20% of the Brazilian pharmaceutical market comprises counterfeit medicines. (http://www.cartacapital.com.br/revista/821/o-mercado-negro-de-medicamentos-1645.html)
The number of counterfeit drugs sent for expert examination in Brazil increased by more than 200% between January 2007 and December 2009. Out of the total number of reports, 80% included counterfeiting of the drugs Cialis® and/or Viagra®. Anabolic steroids were the next most common drug to be counterfeited. (Source: http://www.scielosp.org/scielo.php?script=sci_arttext&pid=S0034-89102012005000005&lng=en&nrm=iso&tlng=en)
Aegate shared its experience captured in the Good Authentication Practice (GAP™) protocol, developed in collaboration with the University of Oxford. GAP™ is a registered trademark of Aegate Ltd. Full details of the GAP protocol are available open access via the European Journal of Hospital Pharmacy: http://ejhp.bmj.com/content/early/2015/10/01/ejhpharm-2015-000750.short?rss=1
Aegate furthered the commitment to promoting stakeholder understanding through the publication of an expert open access resource on falsified medicines regulations in collaboration with leading academics, in the core text for the Regulatory Affairs Certificate (RAC) examination, Fundamentals of EU Regulatory Affairs. Fundamentals of EU Regulatory Affairs, Seventh Edition:
Aegate operates a highly secure real‐time service to verify the authenticity of medicines. This operates seamlessly from manufacturer to pharmacy, and has been independently certified as reliable, secure and 100% accurate. Aegate fully meets the requirements of a number of worldwide legislative efforts to combat falsified medicines, including the EU Falsified Medicines Directive, and is the only medicines authentication provider to provide a validated hospital authentication service, developed in collaboration with the University of Oxford. Aegate are also one of the chosen service providers for the National Blueprint Service available to stakeholders in European countries.
Aegate was established in 2003 and now has its authentication system operating in over 24,000 dispensing points. The Aegate service has checked over 3.7 billion medicine packs and has issued over 2.5 million individual patient safety alerts to pharmacies across Europe. Aegate has offices across Europe and North America and continues to grow year on year through international expansion.
For more information on Aegate, please visit http://www.aegate.com
About R&B Rastreabilidade Brasil
R&B Rastreabilidade Brasil was founded in 2013 and is a specialist in track and trace and check-in services, with 2.5 million IUMS (Identificador Único de Medicamentos) tracked the market and a customer base of 32 laboratories between multinational and national plus one of the largest pharmacy chains from Brazil. In addition, R&B Rastreabilidade Brasil has a validated software according to ANVISA'S RDC 17 and FDA 21CFR PART 11
R&B Rastreabilidade Brasil was created to help all elements of the medicine supply chain and laboratories, to meet completely ANVISA's RDC 54 standards, offering top technology and high quality services.
Using Dashboard R&B Rastreabilidade Brasil you will be able to monitor all track and trace events in real time.
Responsible for First track and trace medicine pilot in Brazil, DATAFARMA R&B has advanced technology to connect to all hardware solutions providing great flexibility for implementation.
R&B Rastreabilidade Brasil and Amazon.com are partners. By using Amazon Brazil's data center to store all data collected with maximum security and efficiency, we have reduced our costs resulting in very attractive prices to our clients.
See more on Link: https://vimeo.com/121161163
For more information on R&B Rastreabilidade Brasil, please visit http://www.rastreabilidadebrasil.com.br