Serialization and uninterrupted traceability verification of the medicinal product, together with the mandatory inclusion of safety devices, have as main objective to reinforce the legal chain of human medical products face to the counterfeit medicines reality.
This system allows to verify the authenticity of the product.
There are currently two types of mandatory safety devices:
- Unique Identifier (UI): to verify the authenticity of the individual packaging of medicines and its identification.
- Tamper-evident device (TE): to prove that the packaging of the product has not been tampered.
This system guarantees anomalies identification, transparence of the whole product process and therefore the quality of the product and patient safety and helps to generate trust in the market and creates confidence in the mind of the patients.
The applicable regulation that can be found on the AEMPS website is the following one:
- DIRECTIVE 2001/83/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 6 November 2001
- DIRECTIVE 2011/62/UE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 8 June 2011
- COMMISSION DELEGATED REGULATION (EU) 2016/161 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 2 October 2015
- COMMISSION DELEGATED REGULATION (EU) 2016/161 SUPPLEMENTING DIRECTIVE 2001/83/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 2 October 2015
As of 2019, serialization process will be mandatory in the pharmaceutical industry.
Qualipharma offers this turn-key service that allows the clients to activate the codes according to the regulation. This service includes ingoing support on serialization, verification and data transfer to the national repository or hub.
- Together with our business partner Lixis, specialist in trace and trace equipment, we master the whole procedure including printing a unique reference code per packaging, carrying out inspections, discard phase and, if required, to group product according to the needs.
- Through Verifarma, activated and deactivated codes are transferred to the national repository or hub. We offer a comprehensive support for generating codes, connecting with other Trace and Trace available systems in the market and transferring codes to the hub.
- Ongoing monitoring post-sales services of trace and trace system to predict and minimize the risk of errors in the transmission of data.
We are expert on serialization, traceability verification and transfer data with hubs, with more than 5 years of experience and successful cases in more than 20 different countries.
- Expert on serialization and traceability equipment
- Comprehensive knowledge of the industry: more than 2000 implementations in countries such as Argentina, Brazil and Colombia among others
- 24/7 multilingual customer service. Qualipharma provides uninterrupted customer service during the whole year