Serialization: How does it affect the pharmaceutical industry?

Counterfeit or distribution of medication whose manufacturing does not comply with the regulations – in some countries it translates into 20% of the pharmaceutical market – has dire consequences, both for consumers’ safety and for the industry’s economy.

Although it clearly affects developing countries the most, Europe does not escape from this problem that has rung the alarm for national and international administrations. But what is the current situation?

European Falsified Medicines Directive

To protect people from this threat to public health, the European Union published the Falsified Medicines Directive about counterfeit medicines. The  European Medicines Verification System or EMVS came into effect on February 9, 2019, in every EU member state (except for Belgium, Italy, and Greece, whose deadline for implementation is 2025).

Therefore, pharmacies are now bound to verify medicines before dispensing them. Otherwise, the competent authorities could impose sanctions in the event of inspections or audits.

Serialization advantages

The implementation of this verification system will constitute a benefit for the consumer and also for authorities, manufacturers and distributors. It will provide a more thorough control of the produced batches. For instance, when making a recall on the market, it will not be necessary to remove a whole batch from the market (since the authorities and the manufacturers will be able to identify each unitary product through the unitary codes).

Thanks to its traceability, consumers ensure products authenticity, the pharmaceutical lab guarantees the medicine’s quality and the pharmacy keeps on working as a guarantee for safe and efficient medicines.

For the pharmacist, this verification speeds up the product recall process, improves the pharmacy’s logistics  (stock, batch and expiration date management) and represents an opportunity to suppress the prescription coupon (the coupon that is cut out when dispensing a prescription medicine). The Spanish Ministry of Health’s intention is to suppress it, although it is not clear how and when this will happen.

How will the Directive affect the pharmacies’ daily routine?

The pharmacist, as the person responsible for distribution, has to be ready to verify medicines, both through a visual inspection of the packaging to certify it remains intact and also through a device that deactivates the unitary codes (by connecting to the Hub and communicating this medicine has been dispensed).

To this end, pharmacies need to have camera-based scanners able to read two-dimensional codes (known as Datamatrix) as well as barcodes, since serialized medicines will coexist with the ones incorporating the usual barcodes (launched before February the 9th).

Along with the scanner or scanners (at least one is recommended at dispensation and another one at reception), pharmacies should adapt their software and should also have their own credentials to access Nodofarma Verificación, -the platform in charge of the connection and authentication through all 22.000 pharmacies in Spain-.

Investment and possible impacts

During the past years, the pharmaceutical manufacturers have been compelled to adapt their infrastructure and to invest great amounts of money to comply with the European Directive against falsified medicines. This investment has translated into the acquisition of new machinery and new technologies for code printing.

The adaptation to the new directive has also meant costs for the pharmacies. The unitary authentication of medicines also entails the task to inform users of the new methodology and train the personnel about how the new system works, as well as how to react when possible incidents arise.

For instance, it may occur that after deactivating a code the patient finally decides not to purchase the medicine. In this case, the pharmacist should ask for a reactivation of the code, contacting with the national repository through the software. The repository verifies if the case meets the conditions to proceed and, if so, the medicine will be dispensable again.

At Nekicesa Packaging we have been working for more than 6 years offering solutions to our clients for unitary code printing and pre-serialization. If you have any doubts or you need advice on how to comply with the directive, do not hesitate in contacting us.

Download exclusive content

Discover the 4 key issues for the application of bollinos.