My bookmarksSign up free

Commission Delegated Regulation (EU) 2016/161 Article 13

Commission Delegated Regulation (EU) 2016/161 Article 13

Reversing the status of a decommissioned unique identifier

Article 13

1.   Manufacturers, wholesalers and persons authorised or entitled to supply medicinal products to the public may only revert the status of a decommissioned unique identifier to an active status if the following conditions are fulfilled: (a) the person performing the reverting operation is covered by the same authorisation or entitlement and operates in the same premises as the person that decommissioned the unique identifier; (b) the reverting of the status takes place not more than 10 days after the unique identifier was decommissioned; (c) the pack of medicinal product has not expired; (d) the pack of medicinal product has not been registered in the repositories system as recalled, withdrawn, intended for destruction or stolen and the person performing the reverting operation does not have knowledge that the pack is stolen; (e) the medicinal product has not been supplied to the public. 2.   Medicinal products bearing a unique identifier which cannot be reverted to an active status because the conditions set out in paragraph 1 are not fulfilled shall not be returned to saleable stock.

Read the full instrument → · Read this in context: CHAPTER III — GENERAL PROVISIONS ON THE VERIFICATION OF THE SAFETY FEATURES →

Other provisions in CHAPTER III — GENERAL PROVISIONS ON THE VERIFICATION OF THE SAFETY FEATURES

Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗ · Data as of 2026-07-04

CitationArticle 13 of Commission Delegated Regulation (EU) 2016/161 (LawPlayer, data as of 2026-07-04)

© European Union, https://eur-lex.europa.eu, 1998-2026. Reuse authorised under Commission Decision 2011/833/EU, provided the source is acknowledged.

What to look at next