Parallel import and parallel distribution

10 September 2018, Updated 13 February 2019
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The Danish Medicines Agency has received questions from parallel importers about the movement of goods after the cut-off date after which the UK will have left the EU.

In July 2017, the Commission generally considered some of the essential principles for goods on the market before the Brexit cut-off date. Please see the page Marketed products for more information about the principles which, according to the European Commission, apply to goods "made available on the market” and goods "placed on the market".

We also refer to the questions and answers from both the EMA and the CMDh/v under Questions and answers. The UK will in many connections be considered a third country after the cut-off date. Several of these questions and answers will as a matter of course also apply to parallel distributed and imported products involving the UK.

In this context, it is important to make sure to consider if changes are needed once the UK is generally considered a third country after the cut-off date.

The Danish Medicines Agency encourages everyone to implement any needed changes well before the cut-off date.

Changes and questions can be sent to parallelimport@dkma.dk

In this context, please also see the Q&As published by the coordination groups for human and veterinary medicinal products in the EU (CMDh/v).

Parallel import from the United Kingdom in case of a no deal scenario (Hard Brexit)

In case of a no deal scenario (Hard Brexit), the United Kingdom will no longer be part of the EU as of 29 March 2019. Consequently, the UK will be considered a third country, implying that the parallel import of medicinal product packs from the UK cannot continue after this date.

In a no deal scenario, the Danish Medicines Agency’s position is that medicinal product packs parallel imported from the UK, having been imported to the Danish or European markets (EU and EEA) by 29 March 2019, can still be repackaged, released and distributed in Denmark until the expiry date of the products. New packs cannot be parallel imported from the UK to the Danish market after 29 March 2019.

The Danish Medicines Agency may change its position in this matter once we know more about the Brexit outcome, and we recommend that you follow our updates on Brexit here on the website.

If parallel importers as a result of a potential no deal scenario (Hard Brexit) expect serious supply difficulties for certain medicines after 29 March 2019, we advise you to keep us informed on shortage@dkma.dk.

Links

The Commission's position paper on Goods Placed on the Market (PDF)

CMDh Brexit information including Q&A

CMDv Brexit information including Q&A

The EMA's information on Brexit

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