Section 3: Import procedures

Active substances may only be imported for the manufacture of medicinal products for human use from a third country into the European Union if they are accompanied by written confirmation from the competent authority of the exporting third country that: 1° The standards of good manufacturing practice applicable to the establishment manufacturing the exported active substances are at least equivalent to those defined by the European Union; 2° The manufacturing…

The written confirmation referred to in article R. 5138-7 is not required when the active substances imported come from a country on the list provided for in article 111b of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use.

Exceptionally and where necessary, in order to ensure the availability of medicinal products, where a manufacturing establishment of an active substance intended for export and located in a third country has been inspected by a Member State and found to comply with the principles and guidelines of good manufacturing practice, the requirement referred to in Article R. 5138-7 may be waived for a period not exceeding the validity of the…