Wholesalers must not receive or buy medicines from non-EU/EEA countries (third countries) nor handle intermediate products

Importation (receipt) of medicines from third countries

An authorisation for wholesale distribution of medicines granted pursuant to section 39(1) of the Danish Medicines Act does not permit the importation (receipt and/or purchase) of medicines from non-EU/EEA countries (third countries). Please note that countries with an MRA agreement (mutual recognition agreement), including Australia, Canada, Japan, New Zealand and Switzerland, are also third countries.

A wholesaler is only permitted to receive and/or purchase medicines from either Denmark or other EU/EEA countries.

Only companies authorised to manufacture medicines pursuant to section 39(1) of the Danish Medicines Act (in the following ‘manufacturing company’) are allowed to receive and purchase medicines from third countries. Medicines that are imported from third countries must – contrary to medicines received from other EU/EEA countries – often be re-analysed and must always be batch released by a Qualified Person (QP) associated with a manufacturing company. Subsequently, the medicines can be distributed in the EU/EEA by wholesale distributors.

Usually it is not a problem to assess whether it is a case of import from third countries, but sometimes there is doubt as to whether medicinal products are released for the European market or imported from third countries.

A medicinal product is released to the EU, but exported to a third country or a medicinal product is owned from a third country

If a medicinal product is released to the EU and subsequently exported to a third country, the product will lose its status as released to the EU. Consequently, the product can no longer be received or purchased by a wholesale distributor in an EU/EEA country until it has been released again by a manufacturing company in an EU/EEA country. Moreover, new reference samples must be made, and if the labelling was changed in the third country, new retention samples are also required.

If a manufacturing company in the EU/EEA wants to release a medicinal product to the EU, which is received from a company in a third country, the release to the EU only applies if the company in the third country releases the ownership of the medicinal product. Thus, it is not possible for a company in a third country to maintain ownership of a medicinal product that is imported to the EU/EEA and will be distributed.

The same applies if a company in a third country buys and takes over the ownership of a medicine batch in the EU/EEA; then the batch will lose its status as released tor the EU, even if the batch is still located in the EU/EEA. Then the batch must be released to the EU again by a manufacturing company in the EU/EEA before it can be distributed in the EU/EEA. We interpret this as not applying to affiliated companies where ownership of the medicine remains within the group. We are in contact with the European Commission to ensure this interpretation is correct.

This means that only manufacturing companies in Denmark can buy medicinal products that have lost the release status, because they are owned by companies in third countries. This also applies to medicinal products that are imported on the basis of a compassionate use permit, see section 29 of the Danish Medicines Act. Moreover, section 29 medicinal products that are imported from third countries must remain in and be used in Denmark. They can only be distributed to other EU/EEA countries if the relevant country‘s authorities accept and continue to accept that medicinal products are distributed from Denmark without a marketing authorisation. Moreover, it is a condition that the relevant country‘s authorities are informed that the imported medicines have not been analysed in Denmark and that there is no requirement in Denmark that the imported medicines are manufactured in accordance with the EU’s GMP, or that reference and retention samples are made. The company is responsible for ensuring that these conditions are complied with.

Our practice in this field is based on announcements from the European Commission about the interpretation of the Medicinal Product Directive.

Medicinal products are owned in the EU, but sent from third country to third country

This is known as ”fiscal importation”. These medicines never enter the EU, but are owned by a company in the EU/EEA that buys and sells these medicines between third countries. The physical handling of the medicines takes place outside the EU/EEA. This situation is not covered by the Medicinal Product Directive.

In Denmark, there is no requirement that such companies hold authorisations, but the EU is currently considering whether joint regulation is required to ensure that such purchase and sale of medicines are controlled, even though they only take place in third countries. Several countries require a Wholesale Distribution Authorisation for this activity.

Export (supply) or sale of medicines to third countries

Even though wholesale distributors are not permitted to import medicines from third countries, it is possible to obtain authorisation to export (supply) or sell medicines to third countries.

Handling of intermediate products

Wholesale distribution of medicines only involves the activities of buying and selling, receiving, storing and/or distributing finished, released (batch certified) medicines that are ready for sale or use in clinical trials. A wholesale distributor is not authorised to handle intermediate products Only companies holding a manufacturer’s authorisation are authorised to handle intermediate products.

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