FMD and Returns with Sigma

Understanding changes to the returns policy post FMD implementation

FMD product returns with Sigma

Following the recent implementation of the Falsified Medicine Directive (FMD) on 9th February 2019, you will see minimal changes to the way you work with Sigma.  However, as a result of FMD there are some changes you need to be aware of:

FMD applies to prescription only medicines, therefore Non-prescription, P meds, GSL, non medicines such as food products and medical devices with CE markings as illustrated below are out of scope.

When a product is returned to Sigma each product will be checked and scanned against the NMVS.  Products that fall under FMD will only be accepted as a return if they meet our standard returns policy and;

  • the 2D barcode and anti-tamper device remain undamaged
  • where the product has NOT been de-commissioned
Updated 20th February 2019

As you may be aware, the EMVS is experiencing several technical issues which is resulting in error messages to its users from the NMVS.  At present it is not known when these technical issues are likely to be resolved.

Potentially with such difficulties in mind, the MHRA have stated;

…. the MHRA will also be taking a pragmatic, flexible approach to how we enforce the new legal requirements, as long as the normal checks are carried out, and there is no reason to think that the medicine is falsified. This position will be kept under review.”

Taking all the above into account and in order for us to help maintain patient supply, Sigma will continue to report the response code issue to the MAH and MHRA until the issues are resolved.

We assure our customers that while we encounter the above issues we continue to carry out our verification processes to ensure all products delivered via Sigma meet quality and patient safety standards.

If your Company is not willing to accept medicinal products with error response codes (but not falsified) from Sigma, approved by our Responsible Person and Quality Assurance Department whilst these technical issues are ongoing please advice by email to qa@sigmaplc.com.

Useful Information on FMD

How do i know if a product is FMD compliant?

All products manufactured after 9th February entered into the NVMS will include an anti-tamper device, a 2D barcode, serial no., batch no. and expiry date.  Examples are shown below:

 

 

 

 

 

 

 

The 2d barcode is normally printed on the side of the pack and can be printed as white on black, or black on white.

Know your Barcodes

You may come across products with a barcode which are not related to FMD.  These may be;

Examples of product markings in pharmacy not covered under FMD.

                  CE Markings                                            Non-prescription                                           QR Barcode (3 squares in the corners)

There will be many packs in the supply chain without the FMD features as they are only required on products manufactured after 9th February 2019.

These products can still be safely dispensed after the normal checks have been conducted.