Serialisation – New EU Aide Memoire for GDP

The Commission Delegated Regulation (EU) 2016/161, which outlines detailed requirements for the application of safety features on the packaging of medicinal products for human use, came into effect on 09 February 2019.

According to a position paper issued by the European Medicines Verification Organisation (EMVO) in July 2019, five months after the safety features implementation date, it was estimated that 40% of all applicable manufacturers and 25% of other ‘supply chain actors’ or stakeholders including wholesalers, hospitals and pharmacies had not connected to the medicines verification system.

At the time that the EMVO position paper was published, approximately 3% of all scans were identified as ‘false alerts’ whereas the target alert level is 0.05%. The aim therefore was that once all ‘supply chain actors’ were fully compliant with the requirements of the new directive, there would be a decrease in the number of alerts that were being generated. To read the position paper in full, including details regarding the key areas for compliance as proposed by the EMVO, follow the link: EMVO Position Paper_July 2019

Data analysis carried out by the Irish Medicines Verification Organisation (IMVO) between 09 February 2019 and 30 September 2019 has revealed that the IMVO were receiving on average 2,500 alerts per day in September 2019 which represented a significant improvement on the number of alerts that were initially being received. The key causes for the alerts generated during this timeframe were as follows:

• Batch not found (approx. 23,000 alerts)
• Pack already in requested state (approx. 11,000 alerts)
• Batch ID mismatch (approx. 7,500 alerts)
• Status change could not be performed (approx. 5,000 alerts)
• Expiry date mismatch (approx. 4,800 alerts)
• Pack not found – unknown serial number (approx. 4,000 alerts)

An aide memoire was recently published by the European Commission on 18 Nov 2019 related to the GDP inspection of wholesaler compliance. It contains six pages of questions that assess wholesaler compliance to the Commission Delegated Regulation (EU) 2016/161 for safety features. It is comprised of a set of general questions, some specific topics and also emphasizes the importance of the technical agreements that should be in place for outsourced logistics provider activities. The full aide memoire can be viewed in the following link: GDP Aide Memoire.

The general questions in this aide memoire are made up a set of high-level questions, for example:

• Is the wholesaler a designated wholesaler? For which companies and products?
• Are there products exempted under Annex 1?
• How are the different requirements for different products controlled/managed?
• At what point is verification conducted?

The questions related to the specific topics cover the following areas:

• Connection to the Repository System
• Registration with the NMVOs
• The Quality System in place
• Verification of the safety features
• Records
• Suspected falsified medicinal products
• Decommissioning of unique identifiers
• Reversing the status of a decommissioned unique identifier
• Provisions to accommodate specific characteristics of Member States’ supply chains
• Training
• Outsourced Activities

A new set of Frequently Asked Questions (FAQ’s) were also issued on the GDP Association Website that relate to Chapter 4 (Documentation) and Chapter 5 (Operations) of the EU Good Distribution Practice Guide. This as available by clicking on the following link (new FAQs on GDP) and the types of questions asked include:

• Who authors documents? Who needs to approve them?
• In which language should documents be written?
• What needs to be considered when importing medicinal product from outside the EU?
• How can I check if a supplier has an appropriate legal authorization?

If you have any concerns that your organisation may not have successfully incorporated the relevant aspects of EU Directive 2016/161 for the application of safety features to medicinal products within your supply chain, Pharmalex can support you.

At PharmaLex, we help organisations assess the robustness and identify potential gaps that may exist in serialisation programmes, or wider GDP activities. In addition, we have trained and experienced GDP professionals available to assist in the provision of contract RP services.  If you would like further information or wish to discuss how PharmaLex can support you, please connect with us at +353 1 8466 4742 or contactirl@pharmalex.com