Countdown to implementation of the National Medicaments Control System

Cases R&B Pharma

Boiron

Boiron, a homeopathy leading company supplies to over 80 countries and has approximately 4,000 employees worldwide. For more than 80 years it has been committed to financing scientific research and educating consumers and HCPs on the homeopathic medicines’ benefits. As a pharmaceutical company, Boiron keeps the highest standards strictly following ANVISA regulations.
As to comply with the National Drug Control System and the current legislations, Boiron Medicamentos Homeopáticos started identification through dataMatrix in Stodal Xarope Homeopático 150 ml, product manufactured by Boiron SA – France.
All events pursuant to RDC 54/13 were duly carried out and recorded within R&B system and are available for consultation. Thus, the pilot test was concluded in compliance with the criteria established by the current legislation, showing the traceability process efficiency of the Boiron products in Brazil.

SETRM 2016

R&B attended SETRM 2016 event, an event organized by USP, HC and Gaesi who presented, among other topics, a model of the SNCM (National Drug Control System) central database to be proposed to ANVISA. R&B took part of this study supporting data streaming platform with a 100% Brazilian solution.

LIBBS

Libbs Farmaceutica is a 100% Brazilian company with more than 50 years of history always in the pursuit of innovation. Located in Embu das Artes, in the state of São Paulo, it is a company that constantly seeks to offer the best to its patients, seeking the best within its own structure firstly, continuously investing in the improvement of its processes, growth of its employees, improvement of its facilities, technology innovation and development of its products.

With that spirit, Libbs decided to embrace traceability and became the first national manufacturer to voluntarily adopt the system and outline an implementation plan across its production lines. Libbs adopted the R&B Pharma solution and in October of 2014, it held an event, with the presence of various government authorities in order to demonstrate the success of the first drug traceability pilot in Brazil conducted in conjunction with R&B.

Hisamitsu

Hisamitsu Pharmaceutical was founded in mid-19th century under the name Komatsuya. A century and half has elapsed and the company developed a broad variety of health-related products, becoming then world leader in the market of analgesic and topical anti-inflammatory medications, position held up to nowadays.

For the concerned project, three boxes, each one from three distinctive batches for the product Salonpas Gel 40g, manufactured by Brazil Hisamitsu Farmacêutica located in the city of Manaus, were duly identified with a Datamatrix code, shipped to the GPZ distributor through a sales process, which, then, made a sale to Organização Farmacêutica Nakano Ltda, which is a dispensing point, both located in the city of São Paulo - SP. Every check-in and check-out event for each establishment were duly performed and recorded within the system, making the product location prompt available in the system for consultation. Thus, the pilot test was concluded in compliance with the criteria proposed by RDC 54/13, showing the traceability process efficiency of the products.

Bracco

Bracco was founded in 1927 in Milan, is a health market-oriented company using innovation in the development of new drugs and products. Being an innovation company, Bracco saw in the Serialization and Traceability project a great opportunity to give its Brazilian customers an extra guarantee at the moment of purchase of its products.

For that, it initially implemented the serialization, in a production line in its production plant in Switzerland, meeting the standard required by the Brazilian legislation for pilot compliance, and following the production, it exported the serialized products to its Brazilian unit, in Rio de Janeiro, where products destined for 3 hospitals were commercialized. During the project, traceability import status, material withdrawal for retention/quality and check-out intended for hospitals were recorded.

D-HOSP

D-Hosp, founded in 1974 acting in retail sales of drugs, standing out for its excellence as service provider due to its constant innovation vision. Taking advantage of this vision, D-Hosp adjusted its warehouse management system in order to perform readings using Datamatrix imprinted by the pharmaceutical industry.

In order to meet the invitation of one of its suppliers, D-Hosp participated in the traceability pilot by making the check-in process for each unit received at its warehouse through the reading of aggregation labels stamped on the shipment boxes, from the 3 batches involved in the pilot.

The 3 batches were commercialized to 3 hospitals referred by D-Hosp and invited to participate in the traceability pilot.
With the units’ sales, D-Hosp recorded within the DATAFARMA R&B system the check-out events for each unit intended for each hospital invited to participate in the pilot, performing check-in events for each of them.

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