On May 5, 2020, Enorama Pharma AB (publ) (“Enorama Pharma” or “The Company”) was informed by the Swedish Medical Products Agency that the Company’s MRP application has passed the final phase, which is called “End of Procedure”. All seven EU member states in which the application is submitted agree with the reference country Sweden that the product meets all the requirements for approval.
Companies that have a nationally approved drug in one of the EU Member States can apply to have this approval recognized in other EU countries through a so-called Mutual Recognition Procedure (MRP). In the fall of 2019, Enorama Pharma announced that the request for Sweden to act as a reference country in the upcoming MRP was accepted by the Swedish Medicines Agency. Subsequently, Enorama Pharma announced which countries would be included in the Company’s MRP application for approval of the nicotine chewing gum in several markets within the EU. Enorama Pharma submitted applications in France, Germany, England, Spain, Poland, Denmark and Greece.
The application process has now passed the final phase where all the EU member states concerned agree with the reference country Sweden that the product meets all the requirements for an approval. In order to nationally approve the product in each individual country, only the submission and review of the national translations of the nicotine chewing gum’s final product information remains.
“It is very gratifying that our MRP process has passed the final phase and that all the member countries concerned agree on the reference country’s evaluation and assessment. Now only administrative formalities remain, and we can conclude that another strategically important milestone has been fulfilled”, says CEO Mats Rönngard, Enorama Pharma.