Dispensing regulations (utleveringsbestemmelser)
NOMA may determine that a drug will be subject to dispensing regulation (1). The pharmacy has a duty to ensure that the requirements for dispensing are met for these medicinal products (2).
(1) Regulation on medicinal products § 7-4
(2) Regulations for requisitioning and dispensing of medicines § 8-4.
The dispensing regulations are related to active substance, pharmaceutical form and strength. They apply to all medicinal products containing the listed active substance or combinations of active substances in the specified pharmaceutical form and strength, including unregistered medicinal products.
The restricted dispensing are often linked directly or indirectly to patient safety issues. Examples are active substances for which it is particularly great risk of teratogenicity or certain antibiotics where it is particularly necessary to restrict use with respect to resistance development.
The list of dispensing regulations
The list of specific dispensing regulations for medicinal products contains only medicinal products that are approved for use in humans (in Norwegian only). Some medicinal products have restrictions on requisition or dispensing outlined in other regulations, these restrictions are not included on the list.
The list is arranged according to the active substance and contains no reference to the product name. Please note that NOMA is not considering restricted dispensing for active substances when there is no approved medicinal product in Norway.
Changes are subject to public consultation
When NOMA considers it necessary to make changes in the dispensing regulations, these proposals are subject to public consultation. This also applies to proposals for the introduction of new dispensing regulations or removing an existing regulation. The consultation paper is published on NOMA website (in Norwegian only).
Exemptions to specific dispensing regulations
In exceptional circumstances exemption from a specific dispensing regulation can be granted for individual patients. In such cases NOMA require a reasoned written application. If an exemption is granted, the patient will get a letter of exemption which must be presented at the pharmacy upon filling of each prescription.