Enorama Pharma AB announces that the Company has applied for a wholesale license at the Swedish Medical Products Agency (MPA) and the inspection date is set to July 24th.
Wholesale licenses are issued by the pharmaceutical authorities. To submit a registration application for medical products in Europe under your own name, you need to have a wholesale license and to comply to the Good Distribution Practice (GDP) rules.
In May, Enorama Pharma filed a wholesale license application. MPA has now accepted the application and their inspection is set to 24 July. The company has prepared and established a comprehensive quality management system that ensures that the company complies with the GDP rules to get a wholesale license for drug-grade products.
“We have been working on this for some time now and we are looking forward to the inspection and receiving the subsequent wholesale license. Wholesale permits are a prerequisite for submission of a registration application and for obtaining marketing authorization so that we can begin selling our first fully developed medical product, which is a nicotine replacement therapy (NRT) gum”
– Annette Agerskov, Vice President Enorama Pharma.
Enorama Pharma’s strategy for applying marketing authorization may differ in different markets and for different products. In Europe, the company has chosen to obtain a whole sale license and thereby own the registration of the company´s medical NRT products. This will strengthen the offer to the market and provide greater future flexibility in how to sell the products in different market segments.