Regulatory Reforms
DLA Piper / Norway
Keen to learn more about regulatory reforms in Norwegian Pharma? Read on! Prepared in association with DLA Piper, a leading law firm in Norway, this is an extract from The Pharma Legal Handbook: Norway, available to purchase here for USD 99.
1. Are there proposals for reform or significant change to the healthcare system?
The most relevant changes to the Norwegian healthcare system expected to enter into force in the near future are the following:
– the new EU regulations on medical devices, namely Regulation (EU) 745/2017 and Regulation (EU) 746/2017 has been implemented into the EEA Agreement, and will respectively and gradually replace the existing national legislation on medical devices. A white paper was issues 28 February 2020 (Prop. 46 LS (2019-2020).
The main changes are;
- More stringent advance control with high-risk medical equipment
- More stringent requirements for technical control bodies with regard to. designation and supervision
- The scope of the regulation has been expanded; Aesthetic products without medical purpose are included
- Strengthened regulations on clinical evaluation and clinical trials
- Stricter requirements for market participants (manufacturer, importer, distributor and authorized representative)
- New requirements for the production and use of medical equipment internally at a health institution, clarifying the “in-house exception”.
- New requirements for reuse of disposable medical devices
- The manufacturer should provide an implant card along with implantable medical equipment.
- Identification and traceability of medical equipment in the production and sales chain.
- Further development of EUDAMED (Central European Medical Device Database)
- Clarified requirements for market surveillance (vigilance) and market surveillance
- Cooperation and governance at European level is strengthened – creation of the Medical device coordination group (“MDCG”), expert panel and reference laboratory.
The new EU regulation on clinical trials on medicinal products for human use, Regulation (EU) 536/2014, which has been implemented in the Norwegian Medicines Regulation Section 15-6a will replace the provisions in the current regulations on clinical trials which implements EU Directive 2001/20/ EC once the EU Portal and EU Database have been successfully established. The main changes are:
- A harmonized electronic submission and assessment process for clinical trials conducted in multiple Member States including the EEA EFTA States;
- An improved collaboration, information-sharing and decision-making between and within Member States and EEA EFTA States;
- An increased transparency of information on clinical trials;
- The highest standards of safety for all participants in EEA/ EU clinical trials.
More information is available here.
2. When are they likely to come into force?
In relation to the above, the following applies:
- Regulation (EU) 745/2017 and Regulation (EU) 746/2017 are have been implemented into the EEA Agreement; however, it is yet uncertain when their provisions will be implemented and apply in Norwegian law. A white paper has already been issued 28 February 2020 (Prop. 46 LS (2019-2020).
- The changes in the LUA regulation are excepted to e.i.f. 2020.
Regulation (EU) 536/2014 has been implemented into the EEA Agreement, and been implemented in Norwegian law. As the entry into force will depend on when the EU Portal and EU Database have been successfully established in accordance with Art. 82 of the Regulation, the entry into force is still uncertain. However, as of May 2020 audit of the EU Portal and EU Database is expected to commence end of 2020, which implies that the Regulation, is not likely enter into force in Norway until 2021.
