My bookmarksSign up free

Commission Delegated Regulation (EU) 2016/161 CHAPTER VIII — OBLIGATIONS OF MARKETING AUTHORISATION HOLDERS, PARALLEL IMPORTERS AND PARALLEL DISTRIBUTORS

Article 40–Article 42 · 3 articles

Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗

Products recalled, withdrawn or stolen

Article 40

The marketing authorisation holder or, in case of parallel imported or parallel distributed medicinal products bearing an equivalent unique identifier for the purposes of complying with Article 47a of Directive 2001/83/EC, the person responsible for placing those medicinal products on the market shall promptly take all the following measures: (a) ensure the decommissioning of the unique identifier of a medicinal product which is to be recalled or withdrawn, in every national or supranational repository serving the territory of the Member State or Member States in which the recall or the withdrawal is to take place; (b) ensure the decommissioning of the unique identifier, where known, of a medicinal product which has been stolen, in every national or supranational repository in which information on that product is stored; (c) indicate in the repositories referred to in points (a) and (b) that that product has been recalled or withdrawn or stolen, where applicable.

Products to be supplied as free samples

Article 41

The marketing authorisation holder intending to supply any of his medicinal products as a free sample in accordance with Article 96 of Directive 2001/83/EC shall, where that product bears the safety features, indicate it as a free sample in the repositories system and ensure the decommissioning of its unique identifier before providing it to the persons qualified to prescribe it.

Removal of unique identifiers from the repositories system

Article 42

The marketing authorisation holder or, in case of parallel imported or parallel distributed medicinal products bearing an equivalent unique identifier for the purposes of complying with Article 47a of Directive 2001/83/EC, the person responsible for placing those medicinal products on the market shall not upload unique identifiers in the repositories system before having removed from therein, where present, older unique identifiers containing the same product code and serial number as the unique identifiers being uploaded.

Back to Commission Delegated Regulation (EU) 2016/161 — full text

Articles on this page are reproduced verbatim from official open data. See the attribution line.

Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.

What to look at next