Enorama Pharma has received a wholesale license from the Swedish Medical Products Agency (MPA). Consequently, Enorama Pharma now has all the approvals required to apply for registration of medical products in Europe.
In July, Enorama Pharma announced that they have applied for a wholesale license from the Swedish MPA, and that they have established a comprehensive quality management system ensuring that the company complies with the Good Distribution Practice (GDP) rules. On July 24, the MPA conducted an audit of the Company with only minor deviations noted.
Enorama Pharma has now obtained the wholesale license necessary to submit a registration for medical products in Europe. As previously announced, all clinical trials and tests of the Company's nicotine gum are also available.
Enorama Pharma's strategy for product registrations may differ from market to market. In Europe, the Company has chosen to acquire the wholesale license themselves to strengthen the offer to the market and provide greater future flexibility regarding how the Company chooses to sell the products.