Manufacture of medicinal products
Manufacturing is defined as the production, packaging, repackaging, labelling, relabelling and release of medicinal products. Manufacturing authorisations for medicinal products for clinical trials, including placebos, are granted pursuant to the provisions of the Norwegian Medicines Act. Manufacturing must take place in accordance with good manufacturing practice (GMP).
A manufacturing authorisation is not required for the simple preparation or packaging of a medicinal product, provided that:
a) the preparation or packaging takes place in pharmacies, hospitals or other health institutions
b) the preparation or packaging takes place immediately before use, and
c) the medicinal product is intended exclusively for use at the site where it is prepared
A simple preparation is defined as “a medicine that, due to its limited shelf life before use, must be prepared immediately before dispensing”.
The pharmacies’ manufacturing authorisation for the simple preparation of medicines is granted pursuant to the provisions of the Norwegian Pharmacies Act.
When it comes to manufacturing beyond the simple preparation of medicines, a pharmacy must have its own manufacturing authorisation. The blinding of investigational medicinal products or placebos requires a manufacturing authorisation when not performed at the same time as simple preparation.
For more information, please consult the Norwegian Medicines Agency’s website:
Permission for a pharmacy to produce medicines for clinical trials
Other useful tools:
National procedure for medicinal product management at the start of clinical trials (PDF)
National procedure for medicinal product management when implementing clinical trials (PDF)
National procedure for medicinal product management when completing clinical trials (PDF)
List of manufacturers of investigational medicinal products
The European Medicines Agency’s database of manufacturing, import and wholesale authorisations, plus GMP (Good Manufacturing Practices) and GDP (Good Distribution Practices) certificates: GMDP database