Quality (Module 3)

The part of the dossier that describes the production as well as various controls of raw materials and the finished product is called quality documentation (Module 3 of the dossier). For herbal medicinal products, regardless of whether the application is full, bibliographic or based on traditional use, as well as for natural remedies, the same requirements as for conventional medicinal products apply.

Herbal substance / Raw material

Cultivation and collection of plants to be used for herbal medicinal products should be in accordance with GACP (Good Agricultural and Collection Practice). Information about GACP is available in EMA quality guidelines for herbal medicines. See links in the right pane menu.

Commercial production

Manufacturing authorisation

All production of medicinal products require a manufacturing authorisation from the MPA and must be in line with GMP (Good Manufacturing Practice).

GMP

The Commission's website provides guidelines on GMP. These are divided into two parts, Part I, concerning quality assurance that is general for all the production of medicinal products. It also includes specific requirements for different dosage forms. Part II establishes the requirements for the manufacture of active substance. See links in the right pane menu.

Guidelines

The European Medicines Agency (EMA) has published a set of guidelines that illustrate various aspects of quality documentation. Most guidelines are generally applicable to medicinal products and a few are specific to herbal medicinal products.

 
 
 

Swedish Medical Products Agency, P.O. Box 26, SE-751 03 Uppsala, SWEDEN | +46 18 17 46 00 | registrator@lakemedelsverket.se | Contact information