From 9 February 2019 onwards, pharmaceutical wholesalers will authenticate the unique identifier for pharmaceutical packages in their physical possession by scanning the Data Matrix Code and based on the reconciliation with the securPharm system triggered this way. At the very least, they must verify the following:
- Pharmaceuticals returned by pharmacies or another pharmaceutical wholesaler;
- Pharmaceuticals they receive from another wholesaler who is neither the manufacturer nor a wholesaler with a marketing licence, nor a wholesaler designated by the holder of a marketing licence in a written contract to store and market the pharmaceuticals subject to said marketing licence on his behalf.
In addition, wholesalers must deactivate the unique identifier for the following:
- Pharmaceuticals to be sold outside of the EU;
- Pharmaceuticals that are returned to the wholesaler and cannot be included in the saleable inventory, e.g. returns due to a product recall;
- Pharmaceuticals to be destroyed;
- Pharmaceuticals that were requested by the authorities as a sample;
- Pharmaceuticals that – pursuant to Section 6 para. 1a of the Arzneimittelhandelsverordnung (German Pharmaceutical Trading Act) – are delivered to individuals, who are authorised and licenced to dispense pharmaceuticals but are not employed at a health care institution or pharmacy, as well as to veterinarians, dentists, the German Bundeswehr, the police, government institutions, universities or other academic institutions.
To inform the participants, securPharm e. V. has generated and sent a letter to all pharmaceutical wholesalers.
The EU-Commission points out the legal obligations of the stakeholders regarding the implementation of savety features under the Falsified Medicines Directive in the letter of 18 october 2018.