ESP and their partners, GS1 Ireland, are once again preparing to publish their annual Serialisation Industry Readiness Report for the pharmaceutical industry.
This year, the focus of the report will centre on the approaching European FMD regulations which will be coming fully into force on the 9th February 2019.
The Falsified Medicines Directive (FMD) “introduces tougher rules to improve the protection of public health with new harmonised, pan-European measures to ensure that medicines are safe and that the trade in medicines is rigorously controlled. To this end, these new measures include:
- Obligatory safety features on the outer packaging of the medicines;
- A common, EU-wide logo to identify legal online pharmacies. This would make it easier to distinguish between legal and illegal online pharmacies throughout the European Union;
- Tougher rules on the controls and inspections of producers of active pharmaceutical ingredients; and
- Strengthened record-keeping requirements for wholesale distributors”.*
The GS1 Ireland/ESP Industry Readiness Report will endeavour to ascertain the extent of the industries activities in preparation for the Feb 2019 deadline – questions such as “What are your principal concerns in relation to your ability to meet your obligations under the EU FMD?” and “Are your warehouse processes ready for EU FMD?” will provide a bird’s eye view into how your level of preparation compares to your peers.
Have Your Say!
This survey is open to all Manufacturers, CMOS, 3PLs and Distributors who will be affected by the directive.
To register your details and take part in the survey, click here.