Import Control

Denmark has implemented the European Parliament and the European Council’s directive 2001/83/EC of November 6, 2001 on the Community code relating to medicinal products for human use. Article 51 in the directive describes requirements for pharmaceuticals freely distributed across EU borders.
Nomeco has decided to name the controls conducted on pharmaceuticals brought into Denmark, import control. Nomeco’s control of imported pharmaceuticals must be covered by a contract manufacturing agreement.

Control report

At delivery of pharmaceuticals from other EU/EEA countries the shipment must be accompanied by a control report. (Executive order GDP § 24)
A control report is defined as a certificate signed by the QP […] that the pharmaceutical, including intermediates and active substances, is manufactured according to good manufacturing practice as well as fulfils the requirements in the marketing authorisation.

In order to accept a document as a control report Nomeco must be able to see the following explicit:

  • The pharmaceutical and intermediates and active substances must be manufactured according to GMP
  • The pharmaceutical fulfils the marketing authorisation. It is important to outline the marketing authorisation explicit and make it clear which market the marketing authorisation applies to (country(ies) or all Europe for central marketing authorisations)
  • A signature by a QP placed in EU or an EEA country

The regulation regarding control reports applies to all pharmaceuticals imported to Denmark from EU/EEA countries. Pharmaceuticals not covered by a marketing authorisation e.g. unlicensed medicines and pharmaceuticals for clinical trials must also be import controlled – not by a control report but by a similar document.

Package master control

If the pharmaceutical is not accompanied by a control report or if the pharmaceutical arrives from a none EU/EEA country the pharmaceutical must be released by a QP within EU/EEA before sale or further distribution is possible. This is described in the executive order GMP.

Regarding release of the supplier Nomeco can control the received pharmaceuticals by a package master.

At delivery between EU countries the Danish Medicines Agency prefers the import control to be conducted by control report but certain conditions may prevent this.