Medicines verification, which aims to prevent falsified medicines from entering the supply chain, will be implemented as of 9 February 2019. After this date, the majority of packages of prescription medicines for human use must bear certain safety features, that is, a unique identifier and an anti-tampering mechanism.
Medicines verification was also on the agenda of the Nordic QA Forum held in Copenhagen on 14 November 2018. Presentations on the topic were given by e-Vis, the organisation which manages the Swedish Medicines Verification System, and the Swedish Medical Products Agency. Judging from the numerous questions asked, pharma companies are not clear about what they need to take into consideration.
Below is a checklist you can use to check whether you have already taken care of the key points.
- Updating of packaging materials for serialisation and (if needed) submission to regulatory authorities.
- Change of product code (NTIN/GTIN) if needed and registering product codes in the national database.
- Onboarding to the European Hub and retrospective uploading of data to the database.
- In-house discussion on how information is transmitted within the company, should the medicines verification system raise an alert.
- Agreement with the national medicines verification organisation (NMVO).
If you were not able to tick all items on the list as done, take action now. And if you are interested in taking the fastest route, contact us.