Wholesale license application at the Swedish MPA

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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.

“The license gives us great flexibility to choose how we sell our products in different markets, in addition to the agreement we, as previously announced, already have in place with a Northern European pharmaceutical company. We estimate that market launch by the Northern European pharmaceutical company will take place in Q3 2019. This way of working will be strategically important and strengthen the company´s market position.”

– Mats Rönngard, CEO Enorama Pharma.

Read the full press release in Swedish