Biotec BetaGlucans AS, wholly owned subsidiary of Biotec Pharmacon ASA, has today filed the first part of the registration file for its new and novel Woulgan® Biogel product.
Svein Lien, CEO of Biotec Pharmacon says: “This is an important milestone in our efforts to commercialize our novel beta-glucans for advanced wound healing. This is a market in need of new products and we have high expectations to our Woulgan® Biogel product that has received a lot of attention in the industry and among health care professionals.”
The filing, which is the Medicinal Product part of the Technical Dossier is filed with the Notified Body, DNV Nemko Presafe AS. They will submit the file to the UK Medicines and Healthcare products Regulatory Agency (MHRA) for their review and approval. This Medicinal Product part of the Technical Dossier refers to the ancillary part of the Medical Device and is needed for the Notified Body to approve and subsequent issue a CE-Mark for the product enabling it to be sold in Europe.
The non medicinal part of the Technical Dossier will be filed to the Notified Body next week.