SKS - Certified IT service provider for Falsified Medicines Directive (FMD)

 

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.

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.

FMD requirements compliant solution

Directive 2011/62/EU: prevention of the entry into the legal supply chain of falsified medicinal products

Suitable for Manufacturers

EMVS Connector is prepared for manufacturers

Suitable for Parallel Importers

Repacking process compatible.
Check-out used packages and register new packages

HELP with on-boarding process

Our specialsts helps you to comply with the requirements with EMVO and register to OBP portal

Serial number generator

Serial number are generated and saved in the system for 6 years

Master Data registration

Master Data records are entered in the EMVS system through EMVS Connector

Information registration to EMVS

After manufacturing or repackaging, all succesfully made products are registered to EMVS

Automated process Ready

According to client requirements, all processes can be held automatically

Integration with CMO system

We are able to integrate EMVS Connector with all your CMO's

Extra benefits

 

Alert system

All alerts from EMVS and National Medicines Verification Systems appears in EMVS Connector

Success stories with TraceLink, SAPh, sFTP data transfer

Contact us

We are happy to talk you through any projects for those wishing to see what it is to use our products and how they look like.