IMPORTATION OF ACTIVE SUBSTANCES FOR MEDICINAL PRODUCTS FOR HUMAN USE
QUESTIONS AND ANSWERS
VERSION 1.0
This documents sets out frequently-asked 'questions and answers' regarding the new rules for the importation of active substances for medicinal products for human use.
These rules are contained in Articles 46b and 111b of Directive 2001/83/EC.
The 'written confirmation' is addressed in Article 46b(2)(b) of Directive 2001/83/EC.