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 the requirements for pharmaceuticals to be freely distributed across EU borders.
Nomeco calls these controls, which are applied to pharmaceuticals that are imported to Denmark, import control. Nomeco's control of imported pharmaceuticals must be covered by a manufacturing agreement.
Shipments of pharmaceuticals from other EU/EØS countries, must contain a control report (Executive order GDP § 24).
A control report is defined as a ”certificate signed by the QP […] stating that the pharmaceutical, including Semi-Finished products and active substances, are manufactured according to the good manufacturing practice, as well as, fulfils the requirements of the marketing authorisation.”
To accept a document as a control report, Nomeco must be able to see the following explicitly:
- The pharmaceutical, semi-finished products and active substances must be manufactured according to GMP
- The pharmaceuticals fulfil the marketing authorisation. It is important to mention the marketing authorisation explicitly, and make it clear, which marketing authorisation is applicable for (countries or all of Europe for central marketing authorisations)
- A signature by a QP located in the EU or an EØS country
The regulation on control reports applies to all pharmaceuticals that are imported to Denmark from the EU/EØS countries. Pharmaceuticals that are not covered by the marketing authorisation, such as non-licensed products and pharmaceuticals for clinical trials, must also undergo import controls, albeit not with a control report, but with a similar document.
Package master control
If the pharmaceutical is not accompanied by a control report, or if the pharmaceutical comes from a non-EU/EØS country, the pharmaceutical must be released by a QP within the EU/EØS before the sale or further distribution is possible. This is described in the executive order GMP.
Nomeco can in connection with a shipments release, check the received pharmaceuticals by a package master.
The Danish Medicines Agency prefers that the import control upon delivery between EU countries is conducted by a control report, but there can be situations that prevent this.