Kymos complies with FDA & EMA inspections as well as GLP, GMP and GCP standards. In particular, as a GMP certified CRO, we take the responsibility tosupply manufacturer authorisation for quality control purposes. In this guide, Kymos helps outline the current situation of Brexit and what this means for batch testing and batch release after Brexit.
Currently a member of the EEA (European Economic Area), the UK may lose their current privileges due to broken international agreements caused by Brexit. These agreements will have to be negotiated and this may affect medicine manufacturing. Currently, the UK government is negotiating with the EU to minimize the impact of Brexit. If the negotiations fail, the presence of the UK as a member of the EMA (European Medicines Agency) may no longer be possible. The EMA has now relocated its headquarters to Amsterdam as a result of the UK’s withdrawal from the EU.
Batch testing and batch release after Brexit’s deadline with no deal
Currently, batch testing and batch release agreements work in an easy way: manufacturers can test batches of medicines from countries of the EU, EEA or third countries if they’re covered with a Mutual Recognition Agreement (MRA). Due to the withdrawal from the EU, the UK will become a “third country”, which implies that “all Union primary and secondary law ceases to apply to the United Kingdom from 30 March 2019, 00:00h (CET)” according to this EU Statement.
To minimise disruption, the British government has been working to stick with international agreements in the case of a ‘no deal’ scenario. To ensure continuity of supply in medicines, the MHRA (Medicines and Healthcare products Regulatory Agency) has prepared a list of the countries (including the EU, EEA and third countries with MRA in it) which will continue accepting batch testing.
One of the main rules, according to the Article 51(1) of Directive 2001/83/EC and Article 55(1) of Directive 2001/82/EC, states that every medicinal product destined to the EEU market, has to be manufactured under the Union GMP requirements and the Marketing Authorisation (MA). Therefore, the batch release site must be located in one of the EEA countries.
This means that all UK pharmaceutical companies that want to place their products on an EEU country, must find a registered and licenced office with EU/EEA licence. This also applies to other activities like batch release and pharmacovigilance activities, which have to be performed by a QP and QPPV located in the EU/EEA.
At Kymos, we take batch release and batch testing very seriously and we are commited to keeping you updated. If you require further information please contact us on +34 935 481 848, email firstname.lastname@example.org or if you are in Barcelona on October 31st join us at the effects of Brexit in the pharma sector seminar.
Institutional guidance and information
The EMA website provides information in order to help prepare pharmaceutical companies of human and veterinary medicines for the UK Brexit situation.
This information contains the following updated documents:
- European Commission/EMA questions and answers
- EMA practical guidance
- European Commission/EMA communication to marketing authorisation holders
- European Commission notice on EU rules for batch testing of medicines in relation to the UK’s withdrawal from the EU
In order to make the transition easier between the old and the new possible situation, the UK government is also releasing information to UK based companies to prepare them for the ‘no deal’ scenario.
- Batch testing medicines if there’s no Brexit deal
- Submitting regulatory information on medical products if there’s no Brexit deal
- Further guidance note on the regulation of medicines, medical devices and clinical trials if there’s no Brexit deal
New information may be released in the future. Latest news suggests that the implementation of a Brexit deal could be delayed and therefore the situation can change on a daily basis.
Practical guidance for procedures related to Brexit for medicinal products for human and veterinary use within the framework of the centralised procedure [PDF]
Brexit: U.K. will become ‘Third Country’ according to EU Statement
Brexit delay now unavoidable, says EU, as Andrea Leadsom and Jeremy Hunt warn of attempt to frustrate departure