New sanction regime for violations of the Pharmacy Act and the Medicines Act enters into force on 1 January 2022
The authority to issue fines will apply in the following instances:
- Illegal import of medicinal products, from inside or outside of the EEA
- Illegal wholesaler activities
- Illegal sale of medicinal products
- Breach of the provisions on marketing of medicinal products in Sections 19 to 21 of the Medicines Act
- Breach of obligation for manufacturers and sellers to provide information as requested when manufacturing or selling narcotics in accordance with a manufacturing permit
- Breach of marketing authorisation holders’ obligation to inform of relevant changes associated with the marketing authorisation application
- Breach of obligation of pharmacies to notify of temporary transfer of license to operate a pharmacy
These rules will be found in the Medicines Act, the Medicines Regulation and the Pharmacy Act. In addition, per the National Insurance Act, negligent or wilful prescription of medicinal products, foodstuffs or medical disposable supplies which can lead to incorrect payment of welfare benefits per the national insurance scheme, can result in fines for the prescriber.
For violations of duties following from marketing authorisations issued according to the centralised procedure, the EFTA Surveillance Authority can issue orders to fine the marketing authorisation holder.
Physical persons can only be fined for wilful or grossly negligent violations, whereas the new Section 28a of the Medicines Act states that corporations can be fined for violations conducted by someone acting on behalf of the corporation, even if no specific individual has acted negligently or wilfully. This provision will, however, have to be interpreted in light of applicable case law on administrative fines, since administrative fines are regarded as penalties per Section 43 of the Public Administration Act.
Fines can only be issued for violations from the last two years prior to the time of the fine. For corporations, the fines can be up to a maximum of 15 times the yearly National Insurance Scheme basic amount (“grunnbeløp”) (currently NOK 1,595,985), whereas for physical persons the maximum amount is two times the basic amount (which currently amounts to NOK 212,798).
The new sanction regime is expected to lead to increased enforcement and in turn better compliance with the regulatory requirements of the Pharmacy Act and the Medicines Act.