Medicines for Human and Veterinary Use
2021.1.18
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 end of the transition period.
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 end of the transition period.
What happens if the entity responsible for pharmacovigilance of the medicine marketing authorisation holder is based in the United Kingdom?
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?
As of 1st January 2021, active substances manufactured in that country shall be considered as imported active substances and must be accompanied by written confirmation from the third country in order to be imported into the EU.
In accordance with the Ireland / Northern Ireland protocol, this written confirmation will not be required to manufacturers of active substances located in Northern Ireland; however, it will be required for manufacturers located in Great Britain.
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 after the end of the transition period.
What happens if the manufacturing plant of my finished medicine is located in the United Kingdom?
As of 1st January 2021, medicines manufactured in the UK will be considered to be imported medicines. In order to continue supplying the EU/EEA the register of medicines manufactured in the United Kingdom must be adapted, including therein a marketing authorisation holder and a batch releaser located in a Member State of the EU/EEA.
What will happen if the control of batches of medicines is performed in the United Kingdom?
As of January 1, 2021, with the entry into force of the Mutual Recognition Agreement, the Good Manufacturing Standards certificates issued by the UK Competent Authorities (MHRA and VMD) will be recognized in the EU and included in the EudraGMDP database.
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. According to the Ireland / Northern Ireland Protocol, in case the promoter is established in Northern Ireland s/he will have to nominate a legal representative in the EU / EEA, the legal representative cannot be located in Northern Ireland. Regarding the place of batch release, the aforementioned is applicable in this case.
We are a medicine distribution entity. Will we be able to keep bringing medicines directly from the United Kingdom after Brexit?
Any medicines coming from the UK will need to be imported by an importing pharmaceutical laboratory as of 1st January 2021.
Will there be any medicine availability problems when the United Kingdom leaves the EU?
As of 1st January 2021, marketing authorizations that do not meet the established requirements will be considered as not complying with European legislation. 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 are not yet and will not be in time will have their authorisations suspended.
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. In the cases of serious epizootics that justify the latter, or when there are mandatory sanitary provisions for the importation or exportation of animals, the AEMPS may authorize the importation of an appropriate immunological veterinary medicine, after a favorable mandatory report from the Ministry of Agriculture, Fisheries and Food.
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 to the batches that have been released for distribution in the EU / EEA before the end of the transition period?
Those batches that have been released for marketing in the EU / EEA before 1st January 2021 will be able to circulate freely in the EU / EEA until their expiration date. Likewise, batches placed on the market before the end of the transition period may continue to circulate from the United Kingdom to Northern Ireland or the EU / EEA without having to repeat the controls.
Non official translation