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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 continue maintaining a valid authorisation and continuing to commercialise medicines in the EU, the authorisation must be transferred to a holder located in the EU/EEA prior to 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?

The application must be transferred to an applicant established in the EU/EEA prior to 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 Brexit goes ahead with an agreement, and pursuant to EU law, the person responsible for pharmacovigilance must be a resident and pursue their activities in a Member State of the EU/EEA. Consequently, you must change your residence and carry on your activities in the EU/EEA, or the holder must propose a new person responsible for pharmacovigilance that meets this requirement.

In addition, the pharmacovigilance master file must be located in a Member State of the EU/EEA.

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

Pursuant to EU law, manufacturers of medicines may only use active substances manufactured in accordance with the rules on the correct manufacture of active ingredients.

Manufacturers located in the United Kingdom are 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?

In the same way as in the case above, at the time of the withdrawal of the United Kingdom from the EU, medicines manufactured in that country will be considered to be imported medicines. In order to continue supplying the EU/EEA as before Brexit, prior to the withdrawal date, the register of medicines manufactured in the United Kingdom must be adapted, including therein a marketing authorisation holder and a drug-eluting stent located in a Member State of the EU/EEA.

Should this not be the case, the competent EU/EEA authorities will ensure that the import of medicines to their territory is subject to an authorisation pursuant to EU law. Manufacturers of medicines located in the United Kingdom will be subject to inspection by the EU authorities as a third country.

Good Manufacturing Practice certificates issued by the competent authorities of the United Kingdom may be taken into account as support documentation in the risk assessment to determine compliance with the Good Manufacturing Practices of manufacturing plants in the regulatory applications.

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.

What will happen if the control of batches of medicine is performed in the United Kingdom?

The manufacturer responsible for the control of batches, in the event of being located in the United Kingdom, must be transferred to another country located in the EU/EEA.

The possibility exists of applying for an exemption for a limited time based on the recognition of quality control trials performed in the United Kingdom.

This exemption is limited to duly justified situations and only for a determined period of time.

Conditions and the procedure to follow can be consulted in this link and in this second link.

When the United Kingdom leaves the EU, will this have any impact on the performance of clinical trials?

The promotor and/or legal representative, as well as the place of the release of the batch, must be transferred to a country located in the EU/EEA.

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

Non official translation