Let’s take a look behind the scenes of secondary packaging.

The legislation aimed at minimising the risk of contamination with regard to the secondary packaging of medicines is essentially based on:

💊 Directive 2001/83/EC: sets general requirements for authorising medicinal products for marketing and contains specific provisions on both the immediate and outer packaging in order to ensure public safety, quality and clear information.

🔗 Regulation (EU) 2016/161: this Delegated Regulation provides the specific rules for applying the requirements of Directive 2011/62/EU (Falsified Medicines Directive), which amends Directive 2001/83/EC. The Regulation (EU) 2016/161 focuses on the safety of medicinal products and the integrity of the distribution chain, requiring a tamper-proofing system and the use of a unique identifier (2D Data Matrix code) for traceability.

🇮🇹 Legislative Decree No. 10/2025: adaptation of national legislation to Regulation (EU) 2016/16; defines technical specifications for the unique identifier (UI) and the anti-tampering system.

📦 ISO 15378:2018: Voluntary standard that establishes requirements for primary packaging (in direct contact with the medicinal product), but whose quality control and hygiene principles also apply to the production of secondary packaging.

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