Falsified Medicines Directive (FMD)
Recently, the European Commission adopted the COMMISSION DELEGATED REGULATION (EU) 2016/161. It provides measures for preventing the entry of falsified medicinal products into the legal supply chain by requiring the placing of safety features that consist of a unique identifier and an anti-tampering device on the packaging of prescription medicinal products for human use for the purposes of allowing their identification and authentication.
The implementation of FMD will be mandatory from 9 February 2019.
FMD poses new demands on marketing authorisation holders, manufacturers, and parallel importers in the EU.
There are three key elements of the new regulation:
- Manufacturers have to codify and label each individual package of the medicinal product with a unique identifier (serialisation) printed on the secondary package in the form of a 2D bar code, and also to protect the package from unauthorised opening and tampering with the contents of the package. These elements are referred to as the safety features.
- The marketing authorisation holders and parallel importers have the obligation to send the defined data set on each individual package into the national repositories and the European Hub.
- Pharmacies and wholesalers have to check the validity of each package of the medicinal product that they dispense to patients, or send it to the end-users who do not have the means of checking the validity of safety features, and to decommission the unique identifiers.
The regulation will affect the whole supply chain, from manufacturers and marketing authorisation holders to wholesalers and pharmacies.
The challenges the industry faces:
- Identify relevant products which need to bear the safety features
- Identify the impact on your medicinal products
- Produce and store relevant product information
- Handle mock-up variations and implement the safety features
- Create the defined data set, submit it to the repository, and keep records of the data for certain period of time
We have added features to READY! that will enable organisations to maintain relevant data in the READY! medicinal product database, create security codes, exchange them with the manufacturing, and submit them to the Hub.
A standard part of our solution is also tracking and archiving these codes for each product and batch.