The directive (EU) 2016/161 “Falsified Medicines Directive” has now been published. Stefan Oeing, Director Business Development at Atlantic Zeiser came together with other experts to discuss this topic during the 10th Jahresforum Pharma Packaging in Berlin to discuss this topic. For those who are familiar with the range of expectations, the discussion revealed that although the changes are minor, they could still have an effect on serialization and aggregation decisions. In particular:
- There are mainly four and in some cases five, plain text lines to be expected next to the Data Matrix code. Serial number and product code, e.g. GTIN enforced by the new regulation 2016/161. EXP and LOT are already demanded by previous regulations.
- The serial number has to be randomised in such a way that it cannot be guessed by a probability of at least 1:10000.
- Combination of product code and serial number must be unique for at least five years and one year longer than the EXP date.
- Quality of data matrix code must be 1.5 or better, what corresponds to grade “C” and better.
- Wholesalers have to check authenticity of single packages for:
a) returns from other wholesalers or pharmacies
b) deliveries from other wholesalers
c) Is this a strong argument for aggregation?
We will of course remain at your disposal should you have any further questions.
The Delegated Regulation 2016/161 is available in 23 languages at: http://eur-lex.europa.eu/legal-content/en/ALL/?uri=CELEX:32016R0161