Enorama Pharma submits marketing authorization applications to the Swedish Medical Products Agency
On 27 September 2018, Enorama Pharma AB (publ) ("Enorama Pharma" or "the Company") has submitted marketing authorization applications to the Swedish Medical Products Agency for each of the Company's four nicotine products - 2 mg and 4 mg of mint and fruit flavored chewing gum.
These applications are a first step towards the approval of the products in the EU. We have chosen Sweden as reference country in the forthcoming MRP process (Mutual Recognition Procedure) in order to facilitate the licensing process in other EU countries.
This gives us increased flexibility to the national markets within the EU, as we can choose between filing a complete application to the national authorities of our priority markets or to build upon the existing MRP process.
Read the full press release in Swedish