Without prejudice to any arrangements which may have been concluded between the Union and third countries, a competent authority may require a third country manufacturer to submit to an inspection as referred to in Article 63(4) of Regulation (EU) No 536/2014 and this Regulation.
Lorsque l'inspection montre que le fabricant ne se conforme pas aux bonnes pratiques de fabrication des médicaments expérimentaux, l'autorité compétente consigne cette information dans la base de données de l'Union visée à l'article 111, paragraphe 6, de la directive 2001/83/CE.