Commission Delegated Regulation (EU) 2017/1569Show full title

Article 12 Responsibilities of the qualified person

1. The qualified person referred to in Article 61(2)(b) of Regulation (EU) No 536/2014 shall be responsible for the following:

(a) where investigational medicinal products are manufactured in the Member State concerned, verifying that each production batch has been manufactured and checked in compliance with the requirements of good manufacturing practice for investigational medicinal products laid down in this Regulation and the information provided pursuant to Article 25 of Regulation (EU) No 536/2014, taking into account the guidelines referred to in Article 63(1) of that Regulation;

(b) where investigational medicinal products are manufactured in a third country, verifying that each production batch has been manufactured and checked in accordance with quality standards at least equivalent to those laid down in this Regulation and the information provided pursuant to Article 25 of Regulation (EU) No 536/2014 taking into account the guidelines referred to in Article 63(1) of that Regulation.

The qualified person shall certify in a register or equivalent document provided for that purpose that each production batch complies with the requirements laid down in paragraph 1.

2. The register or equivalent document shall be kept up to date as operations are carried out and shall remain at the disposal of the competent authority for at least five years after the completion of or the formal discontinuation of the last clinical trial in which the product batch was used.