Industries

Digital Product Passport for pharmaceuticals

Serialisation under FMD is mandatory, and the electronic product information (ePI) rolls out step by step from 2026 - the demands on the DPP are especially high.

Industry challenges

Pharma is especially strict:

  • individual packs, no batch focus
  • temperature logs often as required data
  • consumer information strictly regulated (no marketing in the DPP)
  • global supply chains with the highest audit requirements

Pharma is not covered by the ESPR. Mandatory instead are FMD serialisation and, with the EU Pharmaceutical Package, the electronic product information (ePI) step by step - voluntary at first from 2026, and in future mandatory for newly authorised medicines. DPP structures complement both.

Required data

What goes in the DPP for Pharmaceuticals?

The key data fields required by the relevant EU regulation.

Serialisation

Unique identifier per pack under the EU FMD (Directive 2011/62/EU).

Active substances

Active Pharmaceutical Ingredients (APIs) with origin and purity.

Supply chain

Production sites, distribution routes, temperature logs (cold chain).

Registration

Marketing authorisation number, indications, contraindications, side effects.

Our approach

Transpareo for Pharmaceuticals

Transpareo for pharmaceuticals:

  • Unique identifiers per pack for serialisation requirements
  • Cold-chain and audit documents uploadable as an attachment per DPP
  • Release of the prescribing information for healthcare professionals per plan or user group
  • REST API for updating DPP data from your pharmacovigilance systems
FMD
Serialisation
2D
Data matrix
Cold
Chain log
Rx
Access levels

Ready for Pharmaceuticals DPPs?

Start today - DPP structures complement FMD and ePI, long before any obligation takes effect.

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