My bookmarksSign up free

Directive 2001/83/EC of the European Parliament and of the… Article 127

Directive 2001/83/EC of the European Parliament and of the… Article 127

Article 127

1. At the request of the manufacturer, the exporter or the authorities of an importing third country, Member States shall certify that a manufacturer of medicinal products is in possession of the manufacturing authorization. When issuing such certificates Member States shall comply with the following conditions: (a) they shall have regard to the prevailing administrative arrangements of the World Health Organization; (b) for medicinal products intended for export which are already authorized on their territory, they shall supply the summary of the product characteristics as approved in accordance with Article 21. 2. When the manufacturer is not in possession of a marketing authorization he shall provide the authorities responsible for establishing the certificate referred to in paragraph 1, with a declaration explaining why no marketing authorization is available. TITLE XIV FINAL PROVISIONS

Read the full instrument → · Read this in context: TITLE XIII — GENERAL PROVISIONS →

Other provisions in TITLE XIII — GENERAL PROVISIONS

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 127 of Directive 2001/83/EC of the European Parliament and of the… (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