The Messy FMD Deadline

07.02.2019
Serialization

This is, finally, the week of the grand deadline of the EU FMD (Falsified Medicines Directive). Considering the amount of work required from all stakeholders, the ecosystem has fared fairly well. The full test of the system is about to come when: pharma manufacturers (MAH and CMO) begin communicating the codes with each other and reporting the codes to the repositories; wholesalers and 3PL begin checking the codes in suspect cases and decommissioning the codes of products shipped to mass users, and pharmacies begin authenticating the products and decommissioning the codes.

Stabilization Period

As is well known, a lot of MAHs have begun the system setup late. Reasons are many: there may be too little resources in the company or other projects, such as a concurrent factory upgrade, have consumed the personnel and monetary resources. Some of the smaller MAHs have studied their product repertoire, made some calculations, and found that the few Rx products that they act as a MAH for (using a CMO as a manufacturer), are not worth the investment. Thus, they have reoriented themselves as MAH to OTC products only and just an importer/wholesaler for Rx products. This is understandable as for some generic drugs there is a multitude of both manufacturers and MAHs available and thus very heavy competition based on price or brand recognition.

A safe bet is that a vast majority of the code verification problems stem from other sources:

  1. export codes from India, indistinguishable from the EU FMD codes
  2. EU FMD codes printed in product batches released to market before the 9.2.2019 deadline without uploading the codes to EMVS due to EMVS or level 4 software not available

For these cases, we have different local guidance in e.g. Finland and Denmark. Dirk Rodgers discussed the Danish solution in a recent blog post.

 Danish Medicines Agency Lægemiddelstyrelsen (Denmark):

“Because the safety feature provisions do not enter into force before 9 February 2019, medicinal products manufactured before this date may not necessarily be uploaded to the repositories system. Attempts to verify these products will appear in the system as ‘unknown’. As medicinal products may have a shelf life of up to five years, it may take up to five years before all medicinal product packs covered by the safety feature provisions are uploaded in the repositories system. The Danish Medicines Agency finds that during this period, no action should be taken in response to medicinal products returned as “unknown” by the repositories system in connection with a verification attempt. The suppression of packs returned as ‘unknown’ by the system has to do with the product’s authorised shelf life. It remains important, however, to report it to the Danish Medicines Agency if a medicinal product pack looks suspicious or if there are visible signs of falsification.” (link)

 Finnish Medicines Agency Fimea (Finland)

Reporting to Fimea is not required, however, when reading the 2D barcode, according to the procedures agreed in cooperation among wholesaler and retail logistics chain parties, it is unequivocal that they have been freed to free traffic in the EU region before 9.2.2019. It must also be unequivocal that the question is not of an suspected falsified medicinal product. In these cases, if the aforementioned conditions are met, and there is no basis for suspecting a falsified medicinal product, the product can be dispensed to the customers.” (unofficial transl. by Iiro Jantunen, org. link)

These questions have also been noted by the EMVO, which has proposed a ‘Stabilisation Period‘ with “flexible alert handling” and an increase of EMVS stability and performance. The Stabilisation Period is expected to run for roughly 8 months until September 2019. The Stabilisation Period is not, however, for delaying serialization of medicines at the production lines.

National Legislation Processes

I have not looked too much into the other countries implementing EU FMD, but in Finland, at least, we are on a deadline-licking schedule. Due to the concurrent healthcare and social services reform that has overloaded the Finnish Ministry of Social Affairs and Health with legislative work, the Finnish government was able to give the implementation proposed legislation to the Parliament of Finland on 29.11.2018, and after a speedy hearing and approval process (including the equally overloaded Social Affairs and Health Committee of the Parliament), the legislation was approved on 5.2.2019. There is thus just a couple of days left for the President of Finland to sign the law before the EU FMD deadline.

Have other countries had similarly delayed legislative processes?

Brexit Mess

The possible Hard Brexit would cause a lot of trouble to the pharmaceutical industry in general (in addition to other industries, of course). Importing drugs from the UK would work similarly as from other 3rd countries, with the MAH responsible for the upload of the serialized codes to the EMVS. What may cause trouble, however, are the medicinal packages made for the UK market and uploaded to the EMVS before the day of Brexit. As the case of uncontrolled Hard Brexit would sever the link between the SecurMed (UKMVO), there may be code verification or decommissioning problems, resulting in e.g. ghost codes lingering in the EMVS even after the medicines have been used.

In any case, the British are left with a discussion about delaying the authentication at the point of dispense requirements for the case of GPs. This would require the wholesalers to decommission the serial codes before shipping the drugs to the GP surgeries. Another minor headache in the UK EU FMD case is the crown dependency of Gibraltar as well as Sovereign Base Areas on Cyprus, which are deemed out of scope for EU FMD and, thus, medicines shipped to them from areas governed by EU FMD, including UK, Spain, and the Republic of Cyprus, would have to be decommissioned in the EMVS. In the case of no Hard Brexit, however, it has been clearly stated that the EU FMD will apply to the UK unless “specifically revoked”. We’ll see.

Servicepoint offers services of an experienced full-service packaging, device assembly, machine vision, robotics, and serialization and track & trace automation integration company. In the last few years, Servicepoint has implemented serialization to more than a dozen sites for several manufacturers, our implemented or started projects at customers ranging from Russia to Spain, from Finland to Cyprus. Call us, we can help you!

Merry FMD deadline to you all!

Servicepoint Kuopio Oy — the reliable partner for the manufacturing industry

Iiro Jantunen
CTO, Chief Technology Officer
Servicepoint Kuopio Oy
iiro.jantunen@servicepoint.fi
+358 44 7868 215