Serialization and verification of medical products

Serialization and verification of medical products

Oral presentation

Nedelko Nedelkov
Faculty of Chemistry and Pharmacy, University of Sofia “St. Kliment Ohridski”, Sofia

In order to counteract the spread of counterfeit medicinal products, the European Union adopted a Directive on the fight against falsified medicinal products (Directive 2011/62 / EU), published on 1 July 2011. The draft provides for the introduction of a unique number from 9 February 2019 of each pack of medicines in combination with a mandatory packet integrity indicator. The two markers will indicate that the packaging is unique and that the contents, blisters or ampoules are not changed. The Directive also requires the establishment of a national system for the verification of medicinal products, which will keep information on individual identification marks and will allow for a check in the pharmacy of each package given to a patient. National systems will be linked to a European verification system and will work in synchron with it.