With the official publication of the European Union Delegated Act (EUDA), the clock starts for pharmaceutical manufacturers who supply drugs for the E. U. market to include two safety features on their drug packages. One safety feature is some type of tamper evident seal, and the other is a “unique identifier”, also known as “serialisation” (see “The ‘Unique Identifier’ in the EU Delegated Act“).
I posted an essay when the first draft of the EUDA was made available back in August of 2015 and I used the wrong terminology at that time (see “Breaking News: The EC Has Published The Delegated Act“). In the European Commission (E.C.), the term “published” is reserved for the final publication of the adopted law when the law has been carefully published in all 23 official languages of the E.U.. That is what happened today.
So, the deadline is now set for February 9, 2019 for full serialization and authentication of all drugs, except for Belgium, Greece and Italy which do not have to comply until February 9, 2025 because they already had a type of pharma serialization system at the time this new one was adopted.
The website that contains the newly published EUDA is: http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv:OJ.L_.2016.032.01.0001.01.ENG&toc=OJ:L:2016:032:TOC .
I will have much more to say about the EUDA now that it is official in the coming months.