Disinfectans - approval, manufacturing and import
The regulations for approval, manufacturing, and import of disinfectants depend on the classification of the product.
Products for disinfection are classified differently depending on their intended use and the claims made in their marketing. Companies wishing to import disinfectants for resale must assess the classification of the product before the Norwegian Medical Products Agency (NOMA) can provide further guidance.
Disinfectants for technical use in health care and nursing
General disinfectants for hand and surface disinfection are biocidal products and are mainly managed by the Norwegian Environment Agency. Products used for technical disinfection (surfaces, instruments, equipment) in the healthcare sector are additionally managed by NOMA.
All biocidal products (including disinfectants for technical use in health and nursing care) must meet the requirements for general disinfectants, which can be found on the Norwegian Environment Agency's website. Inquiries about biocides can be directed to the Norwegian Environment Agency.
NOMA assesses applications for the approval of disinfectants for technical use in health care and nursing.
Disinfectants for technical use in aquaculture facilities
NOMA assesses applications for approval of chemical disinfectants for technical use in aquaculture facilities and beyond. In collaboration with the Norwegian Veterinary Institute, this ensures uniform case processing for such applications.
All biocidal products (including disinfectants for aquaculture) must meet the requirements for general disinfectants, which can be found on the Norwegian Environment Agency's website. General inquiries about biocides can be directed to the Norwegian Environment Agency.
Guidance and application form for approval of chemical disinfectants for technical use in aquaculture facilities and beyond
Products intended by the manufacturer for cleaning, disinfecting, or sterilizing medical devices are classified as medical devices and must be CE marked before being placed on the market. Information on classification of medical devices can be found on this page. Inquiries regarding medical devices should be directed to email@example.com.
Products intended for wound treatment will likely be considered as medicines in most cases. While for products to be used on intact skin, an assessment will be made for each product – where elements such as the recommended area of use, any claims presented by the product, and whether it targets a specific professional group will be part of the assessment.
Products marketed with claims of protecting against infection will generally be considered as medicines. Medicines must have a marketing authorisation before they can be placed on the Norwegian market.
Manufacturing of disinfectants in pharmacies
Pharmacies with a manufacturing license can manufacture disinfectants classified as medicines. Such manufacturing requires a prescription/requisition.
Everyone who manufactures disinfectants that are biocides must meet the requirements given in the biocidal regulations. This also applies to production in pharmacies.
Pharmacies can manufacture ethanol-based disinfectants for technical use in health and nursing care without seeking approval from NOMA. Other disinfectants for technical use in health and nursing care must be approved by NOMA (see the section "Disinfectants for technical use in health care and nursing" above). However, the requirements given in the biocidal regulations also apply to these types of products.