Guidance on approval of disinfectants for technical use in health and nursing

General disinfectants for hand and surface disinfection are mainly managed by the Norwegian Environment Agency. Products used for technical disinfection (surfaces, instruments, equipment) in the health care sector are additionally managed by NOMA.

All biocidal products, including disinfectants for technical use in health care and nursing, must meet the requirements for general disinfectants which can be found found on the Norwegian Environment Agency's website. Inquiries about biocides can be directed to the Norwegian Environment Agency.

Legal Basis

Please see ”Forskrifter om kjemiske desinfeksjonsmidler til teknisk bruk i helse- og sykepleie”.

Application

Applications must be sent to desinfeksjonsmidler@noma.no using the specified form. 

The form must be submitted with attachments:

1. Product description (included in the form). This must be accurately filled out to provide essential information needed to assess the product. All information provided here must be based on the data in the attached documentation.
2. Product labeling: Both the outer and inner packaging should be labeled with the following, preferentially in Norwegian:
   1. Name of the product
   2. Active ingredients, name, and concentrations
   3. Net content
   4. Intruction for dilution
   5. Area of use, antimicrobial spectrum
   6. Warnings
   7. Storage conditions
   8. Stability, expiry date
   9. Stability of ready-to-use dilution
   10. Manufacturer, name and company address
   11. Batch number
3. A list of attached documentation must be included.
4. A summary of the documentation for the product must be attached. This should be an updated and complete account of the product based on the collective documentation, edited according to the product description. References to chapters/page numbers in the documentation for all provided information must be specified.

Comments on specific chapters in the product description, attachment 1

Chemical information

In addition to the information provided in the application form, the documentation summary should offer more detailed information. Following editing is suggested:

Disinfecting Substances/Auxiliary Substances

Substance description: generic name, structural formula, chemical name, gross formula, molecular weight, appearance, incompatibility with other substances or packaging, etc.

Quality standards: manufacturer's quality requirements

Control methods: The methods used by the manufacturer in their quality control should be detailed enough that they can be performed in other laboratories without difficulty.

Durability: results of the durability study, preferably under various storage conditions.

The product in the form and packaging that is marketed

The complete qualitative and quantitative composition is specified in the form, attachment 1 "Product Description."

Quality standards: the manufacturer's quality requirements.

Control methods: the manufacturer's methods described in detail.

Durability: results of the durability study; the minimum requirement is the quantitative determination of disinfecting substances. Storage conditions and shelf life, up to a maximum of 5 years, must be specified. Durability studies for ready-to-use (unused) solution should also be present.

Packaging: description of the packaging material.

Toxicological Information

A toxicological assesment based on all available data should be given. Each substance and final product should be considered. Results from acute-, subcronic- and cronic toxicological studies, from mutagenesis-, carcinogenecis- and reproduction-toxicity studies and toxicokinetic studies should be given, if availible. If data are not available this shoud be stated. Experience from human exposure is of grate value.

Data from performed studies and from the literature must be considered. A summary (abstract) of study reports must be attached and reference to literature data must be given.

General Information

Manufacturers or representatives/importers must immediately report any changes to the product or packaging during the registration period. New information on the product's disinfecting effect, harmful effects on users, harmful effects on materials, or toxicological data must also be promptly reported to NOMA.

NOMA will inform the manufacturer or representative/importer about reports of significant importance for assessing the product's effect and safety as they arise. NOMA will be able to further disseminate the information provided in the form, attachment 1 "Product Description."