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November 23, 2016

Falsified Medicines Regulations of Annex 16 and their practical implementation

The EU GMP Annex 16 has been revised in order to reduce the risk of undiscovered sub-standard medicines in the supply chain. Using the example of one of our customers we present the guideline’s requirements and show how to fulfill these in practice by introducing two software solutions.

The term Falsified Medicines includes both drugs containing no active substance and drugs containing active substances of an inadequate quality or in improper doses. The most dangerous factor about these falsified medicines is their availability: they are not sold illegally, e.g. on websites, but enter the supply chain in lawful ways. An estimated 100,000 people or more worldwide are killed by falsified medicines every year.


Falsified Medicines
In order to reduce this risk, the revised directive EU GMP Annex 16, “Certification by a Qualified Person and Batch Release” came into effect on 15 April 2016.

The revisions particularly include globalization and require that the entire supply chain be documented, ranging from the active pharmaceutical ingredient, i.e. the components used in producing the active substance to the import and storage of the intermediary products and distribution of the final medicine. The qualified person (QP) responsible for the quality and final release of the product must know the entire supply chain and ensure that all production and storage sites are authorized to carry out their assigned activity.


How can these complex requirements be implemented in practice?

Any supply chain documentation must be updated on a regular basis. The Annex 16 directive does not specify relevant intervals and methods. From our experience we know that for companies that are active on international markets, simple written documentation often constitutes an insufficient method of capturing the complex structures of the supply chain and ensuring regular monitoring. One of our customers, a global pharmaceutical corporation, therefore decided to develop and launch two software solutions. We established a business process for the verification of the supply chain by the qualified person.


Through this process we enable the qualified person to

  • maintain full transparency of the batch-specific supply chain by means of daily updates from various IT systems and GGMP certificates,
  • adjust the actual and target states of the supply chain in order to prevent the intrusion of falsified batches,
  • guarantee GMP compliance (including Annex 16).


The integration of interfaces was an important factor for facilitating the representation and comparison of existing information. Especially the acquisition of relevant data, ensuring they are up to date and consideration of different national licenses adds to the increased complexity. That is why we ensured the solutions’ quality through requirements engineering and by providing expertise on GMP and regulatory compliance, and we conducted a smooth rollout through organizational change management. The establishment of new processes and their anchoring within the organization through appropriate actions such as trainings is indispensable for detecting irregularities in the supply chain quickly and easily.

Not only does this guarantee the future compliance with GMP regulations, the business process and new tools also assist the qualified person in monitoring the complex supply chains, thus improving the quality of the final product.


Falsified Medicines



Do you have any questions about Annex 16 or do you need help to implement the GMP regulations? Please contact us!

Your Contact:

Stewart Spears

Global Head of Business Development

+41 61 717 82 00