Digital Product Passport for pharmaceuticals

No. The Ecodesign Regulation excludes human and veterinary medicines. No delegated act will cover a medicine. What is mandatory is serialisation, since 9 February 2019. The new pharmaceutical legislation adds the electronic package leaflet. A passport in Transpareo holds both, and everything around them, together. It shows the authorised information behind every pack at a readable size. Every superseded version stays retrievable for the audit.

No. The two have different jobs. The unique identifier is a serial number per pack in a Data Matrix code. Pharmacies verify it against the repositories system and decommission it on supply. It proves that a pack is genuine. A passport identifier leads to information about the product. Both can sit on the same pack. Verification against the repositories system stays mandatory in every case, and Transpareo leaves it untouched.

Yes. A manufacturing importer that brings a medicine into the EU carries the same safety-feature duties as a manufacturer in the EU. It applies the identifier and makes sure the data is uploaded before release. The hard part is usually the contract. Third-country suppliers have to deliver the identifier data and the product information in structured form. A scanned document does not do that. With a supplier request in Transpareo, the supplier enters its details straight into the fields.

Electronic product information is the authorised summary of product characteristics, package leaflet and labelling in structured form. Its common standard rests on Fast Healthcare Interoperability Resources (FHIR). Submission is voluntary today, and EMA encourages it. The new pharmaceutical legislation requires the package leaflet in electronic form too. For new applications that applies 24 months after entry into force, for existing medicines after five years. Both need implementing acts that are still missing. The Council adopted its position on 28 September 2026, and Parliament’s second reading is outstanding. Until the text is in the Official Journal, every date is an expectation.

Not as such. The product code in the unique identifier has to identify the medicine. In most member states it rests on a GS1 GTIN or a national equivalent. If your product code rests on a GTIN, Transpareo turns it into a GS1 Digital Link. Without one, Transpareo issues a unique identifier of its own. The QR code leads to the same passport either way.

Medicines information is strongly tiered. The patient text is authorised word by word, and the text for professionals differs from it. Manufacturing and audit records are not public at all. In Transpareo you set for every field who may see it. The authorised product information can be public. Batch records, temperature logs and audit reports are seen only by the readers you admit. The same code shows every reader their part.

Yes, the authorised text, and only in its authorised form. Product information may not be rewritten, shortened or supplemented with promotional claims. For prescription medicines advertising to the general public is prohibited. So a passport serves as a container for authorised content. Data without a promotional message joins it, such as manufacturing origin, cold-chain evidence and disposal information. A machine translation does not replace an authorised language version. Transpareo shows no advertising behind the passport and does not track readers in the browser.

That depends on what it should answer. Serialisation already works per pack, in the repositories system. A passport is usually more useful per product or batch. That is where the authorised information, the manufacturing sites and the batch evidence sit. Transpareo keeps passports per product, batch or item. So you go down to the single pack where there is a reason to.

Longer than the shelf life. Batch documentation has to be retrievable years after the last pack expired. A pharmacovigilance question often reaches back further. So a link printed on a carton has to outlive the carton by a wide margin. Settle before you sign what happens to your passports after a cancellation. With Transpareo, published passports stay reachable at a permanent address. Our provider checklist names more questions.

For the safety features the member states set the penalties, and their authorities enforce them. In practice the consequence weighs more. A pack that cannot be verified may not be supplied. A batch whose data is missing from the system stands still. An unauthorised or outdated text in the product information is an infringement that reaches the marketing authorisation itself. Either way the damage shows as stopped supply.