Consultations on inclusion in the substitution list
Published:
Changes
- : Lenket til NO-side der høringene er tilgjengelig.
The inclusion of medicines in the substitution list must, in certain cases, be sent for consultation. Such consultations are distributed to relevant stakeholders, typically with a consultation period of three weeks.
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Criteria for when inclusion in the substitution list is sent for consultation:
- The medicines have not been assessed with a bioequivalence study (with some exceptions).
- The medicines have been granted marketing authorization based on a bibliographic application (Medicinal Products Regulation § 3-12 – Article 10a – well-established use).
- The medicines have been granted marketing authorization based on a biosimilar application (Article 10(4)).
- The medicines are for local use (eye, ear, skin, and mucous membranes) where bioequivalence is not relevant.
- NOMA seeks input on the evaluation of medical equivalence and considerations regarding medicine substitution in pharmacies.
Consultations
Please see the Norwegian version of this page to see updates on consultations.