Services Regulatory Activities We can provide you with regulatory and marketing authorisation services for your medicinal products. We combine our pharmacological, pharmaceutical, physiological, chemical and biochemical experience and knowledge of the language to provide you with clear and accurate documentation within regulatory affairs. General Perform guidance according to national/European procedures (MRP/DCP/CP) and requirements Assist in contact with the Norwegian Medicines Agency (NoMA) Be your contact point for clarification of national issues in European procedures Be your Norwegian contact with regard to marketing authorisations and maintenance of your products Human and veterinary medicinal products Review and submit marketing authorisations applications to the Norwegian Medicines Agency (NoMA) Translate and submit Norwegian product information (SPC/PIL/Labelling) Review/approval of mock-ups and print proofs of packaging materials Maintenance of marketing authorisations (variations, renewals etc.) Perform Norwegian readability testing of patient information leaflets Prepare and review summary of clinical documentation Prepare and submit Norwegian Risk Minimisation Plan (RMP) materials Prepare and continuously update texts for the Norwegian Pharmaceutical Compendium (Felleskatalogen) Traditional herbal medicinal products Review and submit marketing authorisations applications to the Norwegian Medicines Agency (NoMA) Translate and submit Norwegian product information (SPC/PIL/Labelling) Maintenance of marketing authorisation Marketing Activities We review and translate all kinds of promotional materials, e.g. short product information texts, web sites, invitations, e-letters, presentations and folders for your medicinal products and herbal medicinal products as well as for cosmetics. Medicinal products and herbal medicinal products Review marketing materials for medicinal products for consistency with the Norwegian legislation Translate marketing materials into Norwegian Submit marketing materials to the Committee for Information on Medicinal Products in Norway who acts on behalf of the Norwegian Medicines Agency (NoMA) Review marketing materials for traditional herbal products for consistency with the Norwegian legislation Medical device Support and review product labelling for consistency with the Norwegian legislation Cosmetics Support and review product labelling for consistency with the Norwegian legislation Translate marketing materials into Norwegian Pharmaceutical Wholesaling Services We can support in issues related to wholesale activities. Good Distribution Practice (GDP) Guidance according to national/European requirements Support regarding application for a wholesale distribution authorisation for medicinal products Contact us Mericon AS Postal address: Mericon AS, P.O.Box 2870, NO-3702 Skien, Norway Visiting address: Mericon AS, Papirkaia 8, Klosterøya, NO-3732 Skien, Norway Email: mericon@mericon.no Tel: +47 35 90 85 40 Fax: +47 35 90 85 49 HOME ABOUT US SERVICES CONTACT INFORMATION Idium Web Rediger Personvern