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Commission Delegated Regulation (EU) 2017/1569 Article 16

Commission Delegated Regulation (EU) 2017/1569 Article 16

Advanced therapy investigational medicinal products

Article 16

The good manufacturing principles shall be adapted to the specific characteristics of the advanced therapy medicinal products when used as investigational medicinal products. Investigational medicinal products, which are at the same time advanced therapy medicinal products, shall be manufactured in accordance with the guidelines referred to in Article 5 of Regulation (EC) No 1394/2007.

Read the full instrument → · Read this in context: CHAPTER II — GOOD MANUFACTURING PRACTICE →

Other provisions in CHAPTER II — GOOD MANUFACTURING PRACTICE

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 16 of Commission Delegated Regulation (EU) 2017/1569 (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.

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