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The Falsified Medicines Directive for EU

on 18 April 2016

The Falsified Medicines Directive was first published in the EU Official Journal on July 1st, 2011 and it has been discussed ever since. There have been some developments after 2011 but the waiting period took much longer than expected.

Only on Feb 9th 2016, the regulation is finally published at the Official Journal of European Union and according to the regulation, the deadline is February 9, 2019 for EU Member States excluding Belgium, Italy, Greece, EEA members (Norway, Iceland, Liechtenstein) and Switzerland. The deadline is February 9, 2025 for Belgium, Italy, Greece because they have already an identification system in place.

Due to the number of countries involved and the overall supply chain network complexity the pharmaceutical companies are already confused about the overall program needs and responsibilities.

Supply Chain Wizard provides niche products and services targeting Serialization, Track and Trace, program and it has already started organizing events in Europe as well to increase overall awareness and collaboration among the industry along with their Serialization journey.

The overview the details of the regulation:

The manufacturer shall place on the packaging of a medicinal product a unique identifier which complies with the following technical specifications:

  • The barcode is machine-readable Data Matrix and have error detection and correction equivalent to or higher than those of the Data Matrix ECC200
  • The unique identifier shall consist of the following data elements:
  1. a code allowing the identification of at least the name, the common name, the pharmaceutical form, the strength, the package size and the package type of the medicinal product bearing the unique identifier (‘product code’);
  2. a numeric or alphanumeric sequence of maximum 20 characters, generated by a deterministic or a non-deterministic randomization algorithm (‘serial number’)
  • the number and the record keeping responsibility shall be valid until at least one year after the expiry date of the pack or five years after the pack has been released for sale or distribution
  1. the batch number
  2. the expiry date
  3. a national reimbursement number or other national number identifying the medicinal product, if required by the Member State where the product is intended to be placed on the market;
  • The scope is identified as follows Medicinal products subject to prescription shall bear the safety features unless they have been listed in.
  • Medicinal products not subject to prescription shall not bear the safety features unless they have been listed in.
  • The list shall be established considering the risk of and the risk arising from falsification relating to medicinal products or categories of medicinal products.
  • The price and sales volume of the medicinal product;
  • The number and frequency of previous cases of falsified medicinal products being reported within the Union and in third countries and the evolution of the number and frequency of such cases to date;
  • The specific characteristics of the medicinal products concerned;
  • The severity of the conditions intended to be treated;
  • Other potential risks to public health;
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