CHAPTER IX

MANUFACTURING AND IMPORT OF INVESTIGATIONAL MEDICINAL PRODUCTS AND AUXILIARY MEDICINAL PRODUCTS

Responsibilities of the qualified person
Article 62
1
The qualified person shall ensure that each batch of investigational medicinal products manufactured in or imported into the Union complies with the requirements set out in Article 63 and shall certify that those requirements are fulfilled.
2
The certification referred to in paragraph 1 shall be made available by the sponsor at the request of the Member State concerned.