Regulatory activities

We offer high quality regulatory and marketing authorisation services for your medicinal products.

We have 20 years of experience on regulatory affairs and continuously keep up to date and ensure compliance with national and European templates, guidelines, regulations and requirements. We have a close and good working relationship with the Norwegian authorities.

General

  • Guidance according to national/European procedures (MRP/DCP/CP) and requirements
  • Contact with the Norwegian Medicines Agency
  • Contact point of national issues in European procedures, including applications and maintenance of marketing authorisations

Human and veterinary medicinal products

  • Review and submission of marketing authorisation applications to the Norwegian Medicines Agency
  • Translation and submission of Norwegian product information (Summary of Product Characteristics/Labelling/Package leaflet/Annexes)
  • Review/approval of packaging materials for submission and printing
  • Maintenance of marketing authorisations (applications for variations, renewals, PSUR submissions etc.)
  • Performing readability tests of Norwegian package leaflets
  • Preparation and submission of Norwegian Risk Management Plan (RMP) materials
  • Preparation of and continuously updating texts for the Norwegian Pharmaceutical Compendium (Felleskatalogen)

Herbal medicinal products

  • Review and submission of marketing authorisation applications to the Norwegian Medicines Agency (NoMA)
  • Translation and submission of Norwegian product information (Summary of Product Characteristics/Labelling/Package leaflet/Annexes)
  • Maintenance of marketing authorisations