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MEDICINES FOR HUMAN AND VETERINARY USE

​What happens if I am a business owner with a medicine marketing authorisation and I am based in the United Kingdom?

In order to maintain a valid authorisation and continue marketing the medicine in the EU, you will need to transfer the authorisation to a holder based in the EU/EEA before the withdrawal date.

What happens if I am a business owner applying for a medicine marketing authorisation and I am based in the United Kingdom?

You must transfer the application to an applicant based in the EU/EEA before the withdrawal date.

What happens if the entity responsible for pharmacovigilance of the medicine marketing authorisation holder is based in the United Kingdom?

Whether or not a Brexit agreement is approved, under European legislation, the entity responsible for pharmacovigilance must reside and undertake its responsibilities in a Member State of the EU/EEA. As a result, it will need to change its residence and undertake its activities from the EU/EEA or the authorisation holder will need to propose a new entity responsible for pharmacovigilance that meets this requirement.

What happens if the manufacturing plant of an active substance in one of my medicines is located in the United Kingdom?

Whether or not a Brexit agreement is approved, any active substances manufactured in the UK will be considered as imported active substances when the United Kingdom withdraws from the EU.

Under European legislation, medicine manufacturers are required to only use active substances manufactured according to good manufacturing practice for starting materials. They will be subject to inspection by the EU authorities as a third country.

What happens if the manufacturing plant of my finished medicine is located in the United Kingdom?

As above, any medicines manufactured in the UK will be considered as imported medicines when the United Kingdom withdraws from the EU. In order to continue supplying to the EU/EEA in the same way as before Brexit, you must adapt the registration of UK-manufactured medicines to include an MAH and a releasing entity located in the EEA before the withdrawal date.

Otherwise, the competent authorities of the EU/EEA will ensure that the import of medicines into its territory is subject to an authorisation under European legislation. It will be subject to inspection by the EU authorities as a third country.

We are a medicine distribution entity. Will we be able to keep bringing medicines directly from the United Kingdom after Brexit?

Whether or not a Brexit agreement is approved, any medicines coming from the UK will need to be imported by an importing pharmaceutical laboratory after the effective withdrawal by the United Kingdom from the EU.

Will there be any medicine availability problems when the United Kingdom leaves the EU?

The EU authorities have been telling marketing authorisation holders about the legal obligations on ownership, pharmacovigilance, manufacturing, etc. for months.  At present, most medicines are in a satisfactory situation.  Those that aren't yet and won't be in time will have their authorisations suspended from the withdrawal date.

At the same time, efforts are under way in conjunction with the other Member States and the European Medicines Agency (EMA) to analyse any risk of shortages or prophylactic or therapeutic gaps as a result of Brexit. The potential risks and shortages are scarce, and alternatives are being sought so that such problems do not arise in practice.

What can I do if I identify a veterinary medicine supply problem as a result of the United Kingdom's withdrawal from the EU?

If a first-choice veterinary medicine is not available, European and domestic legislation states that you can:

Exceptionally prescribe a veterinary medicine of another Member State or medicines for human use authorised in Spain.

If medicines from the above categories do not exist, you can apply to the AEMPS (Spanish Agency for Medicine and Health Products) for the exceptional import of a veterinary medicine or medicine for human use.

Might I have problems gaining access to my medicine via the Foreign Medication Service?

The medicines supplied in special situations will continue to be provided as they have been until now, regardless of whether they come from the United Kingdom or not.

For more information visit The Spanish Agency of Medicines and Medical Devices

Non official translation