The European Falsified Medicines Directive, when it comes into force in February 2019, will have detailed rules for the safety features appearing on the packaging of medicinal products for human use. Eamonn O’Mathuna, a senior manufacturing consultant with ESP offers an explanation of the directive, it’s impact on the distribution of medicines & the latest (2017) update affecting pharmaceutical manufacturers.
The European Union (EU) Falsified Medicines (FMD) Directive 2011/62/EU amends Directive 2001/83/EC to safeguard public health by protecting the pharmaceutical supply chain from infiltration by falsified (or counterfeit) medicines and introduces new rules to more rigorously regulate the supply chain.
The Commission Delegated Regulation (EU) 2016/161, that supplements Directive 2001/83/EC, with detailed rules for the safety features appearing on the packaging of medicinal products for human use, has now been adopted and was published in the Official Journal of the European Union on the 9th February 2016. Therefore the Delegated Regulation will come into force from the 9th February 2019 (3 years after its publication).
This Directive will impact the entire pharmaceutical supply chain from drug substance manufacturers to pharmacists dispensing medicines at point of sale.
Scope of the delegated regulation
The delegated regulation applies to the saleable units of all Prescription Only Medicines (POM) except for products on the whitelist e.g. medicinal gases and radionuclide generators. Over The Counter (OTC) drugs are generally not affected except for those on the blacklist i.e. at risk of falsification.
The delegated regulation applies to all 28 countries in the EU and also includes the EFTA countries, Switzerland, Lichtenstein, Norway and Iceland. 3 countries have received derogations to extend the compliance deadline to 9 years (2025). These are Belgium, Greece and Italy. At the time of writing, Belgium had indicated that they will not use this extension but will go-live in 2019.
The main principles of the Delegated Regulation are as follows
- Safety features
- End to End Verification Model
- Verification of high risk practices within the supply chain.
The delegated regulation calls for two distinct safety features that both need to be added to the saleable units to enhance product security. A unique identifier (UI) and a tamper evident device…
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