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.