Services since 1998
EU-FDA MRA and Brexit compliant
Marketing authorisation holding
European marketing authorizations (MA’s) for medicinal products can only be held by European legal entities. We hold such authorizations for non-EU pharmaceutical companies which, for various reasons, do not (yet) have established such EU legal entity. For European companies we can held duplex authorizations, i.e. a copy of the original MA, which subsequently may be transferred to yet other pharmaceutical companies. This service includes the responsibilities related to MA’s such as pharmacovigilance and lifecycle variation support.
Pharmaceutical manufacturing & importation
(Veterinary) pharmaceutical products manufactured outside the EU may only be imported into the EU by an EU legal entity which holds a manufacturing & importation license as issued by the competent autority of an EU member state. We serve as such site of importation for various clients and we have developed various supply and finance models to meet the needs of the usually different situations of these clients. This service includes logistic support to transfer your products from your site of establishment to our warehouses via air or seatransport.
Wholesale and distribution
For the wholesale of pharmaceutical products and active pharmaceutical ingredients (API’s) within the EU, a pharmaceutical wholesale license or an API-distribution license is required. We hold such licenses and act as the distributor on behalf of various clients. This may apply to prescription drugs, OTC products and biotechnological cold chain products. This service includes performing the bona fide checks on your customers as required by EU regulations. For radioactive pharmaceuticals we cooperate with another company which has the necessary licenses to store and distribute radioactive products throughout the EU.
Narcotics including Cannabis
These products are subject to the most stringent EU regulations and require separate highly protected storage locations as well as (separate) narcotics and cannabis licenses. In addition, all transactions and stock alterations need registration and notification to the competent authority. We have the required experience to deal with narcotics or cannabinoids and may support your EU distribution of these kinds of products.