Serialisation: in Full Compliance or a Race Against the Clock?

By Robert Jan Van Der Horst, CIO, DSM Sinochem Pharmaceuticals, and M Kumaresan, Head-IT (AMEA), DSM Sinochem Pharmaceuticals

M KumaresanPharmaceutical Serialisation is the tracking and tracing of the passage of prescription drugs through the supply chain from manufacturing to dispensing to the patient. A unique serial number to each medicinal pack is assigned, which is linked to information about the product’s origin, batch number and expiration date. With less than 10 months to go to the moment that the EU Falsified Medicines Directive (FMD) comes into force (09-02-2019), the serialisation journey shows all signs of a race against the clock. A significant number of businesses

(estimated 25 percent) have not yet started the journey and/or are not yet on full swing. A typical serialisation project easily takes around 6 to 9 months. Considering the duration of the project, the entire industry, including the pharmacies, should have now started the serialisation project. Complicating factors as of today is the lack of expert resources in the industry as well as with service providers, the lack of available equipment in the market activities of systems which can easily double the project throughput time.

A large part of the industry (mainly the market authorization holders and logistic service providers) also needs to connect to the European Medicines Verification System (EMVS). The setup of this EMVS connection also takes time and should be properly planned for. Meanwhile the on boarding fees are already increased and expected to increase further.  Recent Personal experience: I recently bought some medicines in 5 different pharmacies in my neighbourhood where I live, in Barcelona. None of the pharmacies were aware of Serialisation and had no clue that they will have to scan and verify every single pack in less than 10 months from now before it is dispensed to the patient.

Ultimately, this will control the dispensing to the patient as a last step in the total chain and is the proof of the pudding of serialisation. On the other hand, good things also happened in the Market, such as, the majority of the industry will be ready in time. Especially this part of the industry should already be compliant for non-EU markets where serialisation came into force earlier than in the EU. The experience gained in these regions/industries can be of good use for EU FMD compliance DSM Sinochem Pharmaceuticals (DSP) is fully convinced that serialisation will bring benefits to the Pharma Industry. It will deliver brand protection and it will help combat against counterfeiting. Next to that, the entire supply chain (from manufacturer to pharmacist) will become fully tracked and traceable so that pharmacists can always verify the authenticity of the

product before it is dispensed to endconsumers. And in addition, DSP’s “Sustainable Antibiotics Program” fits perfectly with the objectives of serialisation.

 

This program aims to have sustainable manufacturing and to ensure sustainable use. As such, DSP combats

primarily the unsustainable/irresponsible manufacturing while serialization will help the Industry/patients.

The end-markets drive the speed:

• Depending on the end markets where the company is active, serialisation is already or will be soon a legal requirement;

• New markets come up as Saudi Arabia, Ukraine, Russia and Brazil although not always with clear requirements and moving targets in terms of deadlines.

Engage your customers and CMO’s in time:

• As your own customers and CMO’s are simply struggling with the same, it is highly recommended to take the lead in serialisation and demonstrate leadership as a competitive advantage.

Building sufficient time for setbacks:

• As this is a new for most companies, it is evitable that there will be technical setbacks in the solution and you need to overcome these challenges.

• It is hard to predict availability and level of readiness of on-boarding partners. Therefore, have a flexible plan that can cope with priority changes.

Preparing for success:

• Start on time and as early as possible.

• Get your best resources in the project.

• Select a proper vendor that has proven capabilities The success of serialization for

your company is in the simplicity and

practicality in which the recommendations as above can be applied.

Conclusion:

Coming back to the challenge in the title of this article, the entire industry (from manufacturer till pharmacist) should strive for full compliance as there is too much at stake: The responsible supply of medicines to patients, including lifesaving medicines. And also, reinforcing that it is a race against the clock. It is the right time to push the accelerator button at all levels.

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