Are your operations compliant EU FMD regulations?
PharmaSecure can help you by extending support and services to make your organization compliant with EU FMD regulations. Need more information? Get in touch with us today and request a quote for our FMD compliance solutions.
What is EU FMD Mandate?
On February 9, 2016, the Delegated Act on safety features detailing implementation requirements for the EU Falsified Medicines Directive was published in the Official Journal of the European Union. With this publication, the regulations for coding, serialization, compliance reporting and verification as described in the Delegated Act now become binding on the EU member states
Implementation timelines for the EU regulatory requirements, based on the publication date, are as follows:
February 9, 2019 – EU Member States (excluding Belgium, Italy, Greece) EEA members (Norway, Iceland, Liechtenstein) Switzerland
February 9, 2025 – Belgium, Italy, Greece
Unique Identifier requirements: DATA-Matrix Code, developed to ISO-standards, including Product code, unique serial number, Expiry date, Batch number, National health number (Wherever necessary)
How PharmaSecure can help
PharmaSecure is one of the leading providers of regulatory serialization solutions to pharmaceutical companies operating around the world. PharmaSecure is currently a Candidate for being a registered Connection Provider (Gateway Provider) for the EMVO hub. Our solutions are backed by an experienced team that understands the criticality of plant operations and the complexities of Printers and Vision systems. Our teams support your during the entire lifecycle of your FMD journey and ensure you maintain compliance with regulations moving forward.
- Serving pharmaceutical clients for around a decade
- Solutions based on non-proprietary and latest technology to deliver maximum value
- Seamless integration using industry standards
- Modular and easily customisable applications to fit your business process
- Require minimal training/education to end users
- Secure Application access can be enabled to 3PL or Distribution warehouse.
For more details, please contact us or mail to: firstname.lastname@example.org or call us on 022-67556011