Importation of active substances

This document is intended to facilitate a common approach to dealing with the importation of active
substances in accordance with the requirements of article 46b of Directive 2001/83/EC as amended.

For a period after 2 July 2013 it is possible that active substances intended for the manufacture of
medicinal products for human use may arrive at the EEA from countries that are not included in the list
referred to in article 111b and without the required written confirmation. The process map attached
describes the actions that if taken by an importer under these circumstances may facilitate the
avoidance of problems at the point of importation, or later in the supply chain. It must however be
understood that the importer should have taken steps in liaison with its counterparts in the exporting
country to ensure that a written confirmation is obtained. Alternatively, it should have approached the
national competent authority of the EU country of importation and, if relevant, the EU country(ies) of
destination (where the active substance will be used) if the legislation of the destination country
requires it, to apply for a waiver as provided for in article 46b(4) prior to ordering shipment.

The document is intended to promote common expectations and common approaches by Member
States regardless as to the points of control or verification as decided upon by Member States in their
transposing legislation and which may differ between Member States. The actions described for
importers should avoid difficulties in the situation where the new legislation is not yet fully transposed
by all Member States, without prejudice to provisions present in national legislations.

The process asks for information to be provided to EMA and the European Commission at certain
points. This is expected to be necessary only for a short interim period while the new active substance
import rules bed down across the EU. It is to enable EMA to monitor the situation, to coordinate
inspections as needed and to keep the network informed.

The risk assessments submitted by importers (mentioned in the flowchart) should include:

• A clear explanation why no written confirmation has been received from the authorities of the
exporting country;

• The level of stock currently available to the manufacturer of the medicinal product for which the
active substance is to be used;

• The indications for the product for which the active substance is to be used;

• Availability of alternative products and treatments.

* GMPINS@ema.europa.eu
** sanco-pharmaceuticals-d6@ec.europa.eu