Medical Device Regulation – Article 117 Action Required
A recent statement was issued by the European Medicines Verification Organisation (EMVO), warning that June 2018 is the very latest that manufacturers should commence the serialisation process or risk being non-compliant in February 2019. https://emvo-medicines.eu/wp-content/uploads/2018/01/12.01.2018_Letter-of-Announcement-Last-Opportunity-for-a-Timely-On-boarding.pdf. With the publication of the Delegated Act on safety features, those who manufacture, sell or dispense medications in the European Union have until February 2019 to comply with complex track and trace regulations (https://ec.europa.eu/health//sites/health/files/files/eudralex/vol1/reg_2016_161/reg_2016_161_en.pdf) The safety features include a requirement for a Unique Identifier which will be an alphanumerical code enabling the identification and authentication of an individual pack. It involves the assignment of a unique serial linked to the individual production data in the form of a Data Matrix Code. Under the Falsified Medicines Directive, the Marketing Authorisation Holder has several reporting and notification requirements to make to the European hub, the two primary ones being for product master data and serialised product pack data. This means that, by June (yes- in a couple of weeks!), companies will need to have chosen their serialisation solutions, and implementations must have advanced far enough that companies are able to test their systems connection with the European Hub. It is the responsibility of the Marketing Authorisation Holder (MAH) to ensure that an effective end-to-end verification system is in place to prevent falsified medicinal products from entering the supply chain. With effect from 09 Feb 2019, all medicinal product released for sale or distribution must be serialised. Un-serialised medicinal product released in Ireland before 09 Feb 2019, that is not subject to further repackaging or relabelling activities may be placed on the market, distributed and supplied to the public until its expiry date. Are you serialisation ready? Here are some questions to help you to answer this question:
- Do you fully understand the regulations and legal requirements associated with serialisation?
- Do you understand the supply chain flow for all of your products?
- Have you selected your cloud based service provider and established IT infrastructure?
- Have your Standardised Numerical Identifers (SNI) been generated?
- Will you aggregate now or at a later date?
- Have you upgraded and qualified your equipment?
- Has your artwork been updated in line with serialisation?
- Have you updated all associated validation and batch documentation?
- Have your SOP’s been updated to reflect the serialisation process?
- Are your staff trained on the new requirements?
If you would like advice or support in relation to serialisation readiness within your company please connect with us +353 1 846 4742 or contactirl@pharmalex.com
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