Dietary supplement in FEST and FHIR service
Published:
Changes
Dietary supplements are part of the FEST message, originally created for multidose, but today cover much more. Many of the dietary supplements that have been added later cannot be packaged as multidose.
Page contents
Handling of terms for use with dietary supplements at NoMA
There is a need within the specialist health services to support prescribing in hospitals. NoMA also has the right to reject dietary supplements aimed at specific user groups. For example, there is no medical basis for bodybuilding products to be included in the FEST/FHIR service.
Farmalogg reports dietary supplements to NoMA, and they ensure that the submitted supplements contain substances and dosage forms that comply with NoMA standards. Products that do not meet these standards will be rejected. Additionally, NoMA encourages the industry to use the required terminology when submitting new products to Farmalogg to facilitate smoother processes for all parties involved.
At the same time, NoMA encourages the industry to use the terminology required by NoMA when submitting new products to Farmalogg, as this contributes to smoothness for all parties.
Substances to be used in dietary supplements
The legislation that Mattilsynet (Norwegian Food Safety Authority) must follow is somewhat older than the IDMP (Identification of Medicinal Products) standards currently used by the NoMA. As a result, the terminology used by Mattilsynet often differs from the valid terms recognized by NoMA. Only terms that comply with substance names under SMS/IDMP are accepted, excluding old or trivial names.
NoMA does not specify whether a chemical substance is naturally or synthetically produced. For example, ascorbic acid is considered a chemically pure substance regardless of whether it comes from citrus fruits or is industrially produced. It is not labeled as Vitamin C or C-vitamin in the current system. An exception is Vitamin A, which is still listed in the European Pharmacopoeia as a mixture of several substances.
Valid terms to be used in NoMA solutions
Substances
NoMA has developed a table of valid terms for substances, including vitamins and minerals, which aligns with regulations under Mattilsynet, se also Legislation - in Norwegian only, but also goes beyond them by including additional valid substances. This ensures standardized naming and legal compliance in dietary supplement registrations and labeling.
This is a common table used for vitamins and minerals. NoMA has listed more substances than those found at the Norwegian Food Safety Authority because these are valid terms that can, for example, refer to the same mineral.
The list is only presented in Norwegian p.t., may be updated in the future with English terms and available SMS IDs. The list shows Trivial names, Valid names according to NoMA, and Names according to Mattilsynet. When selecting a term, comments from NoMA are also displayed. Some terms are marked as "Non-existent" (Ikke-eksisterende) or "not a substance" (Ikke en substans) under terms from NoMA. We have also has more valid substances that can be used, those are indicated as N/A in coloumn for Mattilsynet.
Click here to view the list in Norwegian
Dose forms
NoMA requires the use of only valid dosing forms mentioned for all preparations that are to be published in the FEST and FHIR services. Products that do not meet these requirements will be rejected by NoMA. This ensures consistency and compliance with regulatory standards in the medicinal product data published for healthcare use.