On 8 June 2011, the European Parliament approved Directive 2001/83 / EC, stating that falsified medicinal products pose a significant risk to the public health sector (point 7 of 2001/83 / EC). This Directive incorporated the requirements which led to the follow of Regulation (EU) 2016/161 of 2 October 2015, which detailed and extended the technical requirements for systems to control falsified medicinal products. Under this regulation, with a few exceptions, wholesale distributors and pharmacies in all Member States are required to ensure the control of falsifications from 9 February 2019.
Wholesalers, who receive medications and pharmacies, hospitals and other health care facilities will be responsible for checking them. They will need to make sure that the medicines are registered in the data warehouse and that they are decommissioned when they are sold to ensure that the products are not resold.
Changes in drug status may include dispensing of drug packages, locking packages for further investigation, destruction of packages, recording of theft and export of packages to third countries. The National Verification System Data Warehouse can provide packaging designs as samples, including free samples.
In accordance with Directive, SKS as an IT company with more than 20 years of experience in the pharmaceutical market, offers IT solutions to help pharmaceutical companies implement FMD smoothly.
If required, the data of the drug counterfeiting system can be collected and integrated with the systems used by the clients.
SKS - Certified IT service provider for Falsified Medicines Directive (FMD)
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