Brexit contingency plans for epilepsy medication
In August 2018, the Government asked pharmaceutical companies to ensure they have a minimum six week stockpile of prescription-only and pharmacy-only medicines in case of potential delays at UK borders after Brexit on 31 October 2019.
We have contacted pharmaceutical companies in the UK to find out what their individual contingency plans are. Their responses are detailed in the table below.
Epilepsy Society's Medical Director, Professor Ley Sander has also advised people with epilepsy not to stockpile medication themselves.
"There is a lot of anxiety about supply of medication post Brexit and some people are finding ways to try to stockpile medicines themselves," he said.
"We understand people's concerns, however this has the potential to create a shortage of medication itself. It is important for everyone to stay calm and follow their normal routine when it comes to getting a repeat prescription.
"The contingency plans put in place by the Department of Health and Social Care are the most effective way to ensure that everyone has a consistent supply of their medication."
Serious shortage protocol
The Government has also confirmed that epilepsy medicines will be exempt from its serious shortage protocol. This will give pharmacists power to dispense alternative drugs if those prescribed by GPs are in short supply at any time, including during the possibility of a 'no-deal Brexit' scenario after Britain leaves the EU.
If there is a shortage of a particular epilepsy medication, clinicians would advise the most appropriate course of action. Where necessary, the Department of Health and Social Care would seek to access the medication from an alternative source.
Find out more below on Brexit contingency plans for epilepsy medications from pharmaceutical companies.
Brexit contingency plans from pharmaceutical companies
Acetazolmide tablets
Company: Crescent Pharma
Dosage: 250mg
Contingency Plan: No concerns. This particular drug is manufactured wholly within the UK and therefore, they do not anticipate any concerns in regard of the manufacture and supply of this drug.
Briviact (briviracetam) oral solution
Company: UCB Pharma
Dosage: 10mg/ml
Contingency Plan:
Update 9/9/19: "Following the update we gave you in March, we are in a much better position with stock holding now as follows with no disruptions for the UK anticipated:
Keppra – Average stock holding 5 months
Vimpat – Average stock holding 5 months
Briviact – Average stock holding 6 months
Nootropil – Average stock holding 4 months"
Below is the response prior to the first Brexit date of 29 March 2019:
"Ensuring patients avoid any disruption to the supply of their medicines is a primary priority for UCB, and as a precautionary measure UCB is increasing stockholding of our core medicines in the UK to cover a 2-month supply period for all products, and a 3-month supply period for many of our medicines to mitigate any potential disruption in a “hard” / “no deal” Brexit scenario.
For UCBs’ AEDs there will be a 2 month supply cover for Keppra (Levetiracetam) in the UK, and a 3-month supply period for Briviact (Brivaracetam), Vimpat (Lacosamide) and Nootropil (Piracetam).
The Medicines Supply Contingency Planning Department for the Department of Health has requested all UK pharma companies to increase their stock holding by 6 weeks (on top of their existing safety stock) to cover the impact of a ‘hard’ Brexit, which UCB has complied with. In addition, the UK Government announced that in the event of a “hard” / “no deal” Brexit many important elements and processes relating to the supply chain for medicines coming to the UK from the EU will remain the same as they are today after March 29th 2019, and that the Government would give pharmaceutical manufacturers at least 2 years notice before any proposed changes to this would be considered.
Because avoiding disruption to patients is a key priority for UCB, we continue to actively and routinely engage UK Government to encourage the development of policies that will avoid disruption to UK patients receiving their medicines."
Carbagen (carbamazepine) tablets
Company: Mylan
Dosage: 100mg, 200mg and 400mg
Contingency Plan: "Our official position regarding the events you have stated is being determined as we speak. Once we have an official statement this will be communicated".
Updated information: Mylan have informed the DHSC that the following preparations of Carbagen (carbamazepine) will be unavailable until mid-late 2019. The affected products are listed below:
- Carbagen 200mg and 400mg Immediate Release Tablets – unavailable until mid-2019
- Carbagen 200mg and 400mg Modified Release Tablets – unavailable until late 2019
Patients currently prescribed Carbagen tablets by brand will therefore need to be switched to an alternative brand of carbamazepine tablets during this time.
Carbagen prolonged release (carbamazepine) tablets
Company: Mylan
Dosage: 200mg and 400mg
Contingency Plan: "Our official position regarding the events you have stated is being determined as we speak. Once we have an official statement this will be communicated".
Company: Thame Laboratories
Dosage: 0.5mg/5ml and 2mg/5ml
Contingency Plan: "We do not anticipate any supply issues with Clonazepam 0.5mg/5ml and 2mg/5ml Oral Solution with either outcome of Brexit."
Clonazepam oral solution
Company: Rosemont Pharma
Dosage: 0.5mg/ml and 2mg/5ml
Contingency Plan: "We do not anticipate any problem with the supplies."
Clonazepam oral solution
Company: Thame Laboratories
Dosage: 0.5mg/5ml and 2mg/5ml
Contingency Plan: "We do not anticipate any supply issues with Clonazepam 0.5mg/5ml and 2mg/5ml Oral Solution with either outcome of Brexit."
Convulex (valproic acid) tablets
Company: Gerot Lannach (Pfizer UK is the distribution partner)
Dosage: 150mg
Contingency Plan:
Update 5/9/19: "Based on the information we have from our partners - Pfizer and Healthcare Pharma, they have planned their orders and deliveries in a way to avoid shortages of Convulex."
Below is the response prior to the first Brexit date of 29 March 2019:
"At this moment I see good coverage for the market . And no issue with supplies of Convulex. I am coordinating between the market and the supplier and will keep you updated".
Desitrend (levetiracetam) granules
Company: Desitin Pharma
Dosage: 250mg, 500mg and 1000mg
Contingency Plan:
Update 12/9/19: "Desitin Pharma has in place plans to manufacture and hold in the UK, by the end of October 2019, 6 months' safety stock of anti-epileptic medication."
Below is the response prior to the first Brexit date of 29 March 2019:
"Desitin Pharma has in place plans to manufacture and hold in the UK, by the beginning of March 2019, 6 months' safety stock of anti-epileptic medication."
Desitrend concentrate solution for infusion
Company: Desitin Pharma
Dosage: 100mg/ml
Contingency Plan:
Update 12/9/19: "Desitin Pharma has in place plans to manufacture and hold in the UK, by the end of October 2019, 6 months' safety stock of anti-epileptic medication."
Below is the response prior to the first Brexit date of 29 March 2019:
"Desitin Pharma has in place plans to manufacture and hold in the UK, by the beginning of March 2019, 6 months' safety stock of anti-epileptic medication."
Diacomit (stiripentol) capsules
Company: Biocodex
Dosage: 250mg and 500mg
Contingency Plan:
Update 9/9/19: Biocodex have said: "be confident that we are anticipating the Brexit deadline very seriously. For UK packs we have more than 6 weeks of treatment on hand all year long, there is no risk of shortage."
Diacomit (stiripentol) sachets/powder
Company: Biocodex
Dosage: 250mg and 500mg
Contingency Plan:
Update 9/9/19: Biocodex have said: "be confident that we are anticipating the Brexit deadline very seriously. For UK packs we have more than 6 weeks of treatment on hand all year long, there is no risk of shortage."
Diazepam Desitin Rectal Solution
Company: Desitin Pharma
Dosage: 5mg /2.5ml
Contingency Plan:
Update 12/9/19: "Desitin Pharma has in place plans to manufacture and hold in the UK, by the end of October 2019, 6 months' safety stock of anti-epileptic medication."
Diazepam Desitin Rectal Solution
Company: Desitin Pharma
Dosage: 10mg/2.5ml
Contingency Plan:
Update 12/9/19: "Desitin Pharma has in place plans to manufacture and hold in the UK, by the end of October 2019, 6 months' safety stock of anti-epileptic medication."
Below is the response prior to the first Brexit date of 29 March 2019:
"Desitin Pharma has in place plans to manufacture and hold in the UK, by the beginning of March 2019, 6 months' safety stock of anti-epileptic medication."
Epanutin (phenytoin) in oral suspension
Company: Pfizer
Dosage: 30mg/5ml
Contingency Plan:
Update 9/9/19: "Our overriding priorities are to ensure continued patient access to medicines and vaccines, avoiding any disruption to existing quality control arrangements and to the supply of medicines and vaccines to patients. We have undertaken work to ensure we can continue to supply in the EU and the UK in all Brexit outcome scenarios and are taking into account UK Government guidance on medicine and vaccine supplies in preparation for the UK leaving the EU under a “no deal” scenario. While plans are in place to ensure continuity of supply, there remains a dependency on external supplier readiness. Pfizer is working with external suppliers to ensure alignment.
Below is the response to the first Brexit date of 29 March 2019:
"In order to minimize any potential patient impact we have undertaken work to ensure we can continue to supply in the EU and the UK covering all Brexit scenarios. We have carried out detailed assessments of the supply of all our medicines with the focus on ensuring we will continue to have them available for our patients. Due to the long lead times we have in our supply chains, and in the interests of all patients across Europe, we are asking the EU and the UK to reach appropriate arrangements for alignment and cooperation for medicines regulation and supply, and to support these alongside other elements to foster longer-term regulatory continuity between the EU and UK".
Epanutin (phenytoin) chewable infatabs
Company: Pfizer
Dosage: 50mg
Contingency Plan:
Update 9/9/19: "Our overriding priorities are to ensure continued patient access to medicines and vaccines, avoiding any disruption to existing quality control arrangements and to the supply of medicines and vaccines to patients. We have undertaken work to ensure we can continue to supply in the EU and the UK in all Brexit outcome scenarios and are taking into account UK Government guidance on medicine and vaccine supplies in preparation for the UK leaving the EU under a “no deal” scenario. While plans are in place to ensure continuity of supply, there remains a dependency on external supplier readiness. Pfizer is working with external suppliers to ensure alignment."
Below is the response to the first Brexit date of 29 March 2019:
"In order to minimize any potential patient impact we have undertaken work to ensure we can continue to supply in the EU and the UK covering all Brexit scenarios. We have carried out detailed assessments of the supply of all our medicines with the focus on ensuring we will continue to have them available for our patients. Due to the long lead times we have in our supply chains, and in the interests of all patients across Europe, we are asking the EU and the UK to reach appropriate arrangements for alignment and cooperation for medicines regulation and supply, and to support these alongside other elements to foster longer-term regulatory continuity between the EU and UK".
Epilim (sodium valproate) liquid
Company: Sanofi
Dosage: 200mg/5ml
Contingency Plan:
Update 9/9/19: "Our main priority is to ensure people in the UK have continued access to the medicines and vaccines they need. The uncertainty in the Brexit negotiations means that Sanofi has been planning for a ‘no deal’ scenario, as recommended by the European Federation of Pharmaceutical Industries and Associations (EFPIA). This has involved working across many areas of the Sanofi business, since early 2017.
We have made arrangements for additional warehouse capacity in the UK to stockpile our products, but we are only able to stockpile medicines and vaccines where global supply allows. For the vast majority of our medicines and vaccines, we’ve added six weeks of stock to our business as usual levels, but valproate is an exception due to a manufacturing disruption last summer.
Sanofi has, however, prioritised valproate supply to the UK as part of our ‘no deal’ preparations. It is important to point out that stockpiling is just one of the mechanisms for ensuring we can supply medicines and vaccines in the UK following a ‘no deal’ departure from the EU. We are now operating additional ferry routes into the country and have secured air freight routes as a further contingency should it be required."
Below is the response to the first Brexit date of 29 March 2019:
"Sanofi welcomes the UK Government’s guidance in the event of no deal in the Brexit negotiations published on 23 August. Sanofi is confident that its existing contingency plans will ensure that people in the UK can access the treatments they need after the UK leaves the European Union. However, we have reviewed our stockpiling plans to meet the Government’s specific guidance to increase UK stock by 6 weeks over existing arrangements".
Epilim (sodium valproate) syrup
Company: Sanofi
Dosage: 200mg/5ml
Contingency Plan:
Update 9/9/19: "Our main priority is to ensure people in the UK have continued access to the medicines and vaccines they need. The uncertainty in the Brexit negotiations means that Sanofi has been planning for a ‘no deal’ scenario, as recommended by the European Federation of Pharmaceutical Industries and Associations (EFPIA). This has involved working across many areas of the Sanofi business, since early 2017.
We have made arrangements for additional warehouse capacity in the UK to stockpile our products, but we are only able to stockpile medicines and vaccines where global supply allows. For the vast majority of our medicines and vaccines, we’ve added six weeks of stock to our business as usual levels, but valproate is an exception due to a manufacturing disruption last summer.
Sanofi has, however, prioritised valproate supply to the UK as part of our ‘no deal’ preparations. It is important to point out that stockpiling is just one of the mechanisms for ensuring we can supply medicines and vaccines in the UK following a ‘no deal’ departure from the EU. We are now operating additional ferry routes into the country and have secured air freight routes as a further contingency should it be required."
Below is the response to the first Brexit date of 29 March 2019:
"Sanofi welcomes the UK Government’s guidance in the event of no deal in the Brexit negotiations published on 23 August. Sanofi is confident that its existing contingency plans will ensure that people in the UK can access the treatments they need after the UK leaves the European Union. However, we have reviewed our stockpiling plans to meet the Government’s specific guidance to increase UK stock by 6 weeks over existing arrangements".
Epilim (sodium valproate) gastro and crushable tablets
Company: Sanofi
Dosage: 100mg and 200mg
Contingency Plan:
Update 9/9/19: "Our main priority is to ensure people in the UK have continued access to the medicines and vaccines they need. The uncertainty in the Brexit negotiations means that Sanofi has been planning for a ‘no deal’ scenario, as recommended by the European Federation of Pharmaceutical Industries and Associations (EFPIA). This has involved working across many areas of the Sanofi business, since early 2017.
We have made arrangements for additional warehouse capacity in the UK to stockpile our products, but we are only able to stockpile medicines and vaccines where global supply allows. For the vast majority of our medicines and vaccines, we’ve added six weeks of stock to our business as usual levels, but valproate is an exception due to a manufacturing disruption last summer.
Sanofi has, however, prioritised valproate supply to the UK as part of our ‘no deal’ preparations. It is important to point out that stockpiling is just one of the mechanisms for ensuring we can supply medicines and vaccines in the UK following a ‘no deal’ departure from the EU. We are now operating additional ferry routes into the country and have secured air freight routes as a further contingency should it be required."
Below is the response to the first Brexit date of 29 March 2019:
"Sanofi welcomes the UK Government’s guidance in the event of no deal in the Brexit negotiations published on 23 August. Sanofi is confident that its existing contingency plans will ensure that people in the UK can access the treatments they need after the UK leaves the European Union. However, we have reviewed our stockpiling plans to meet the Government’s specific guidance to increase UK stock by 6 weeks over existing arrangements".
Epilim Chrono (sodium valproate) controlled release tablets
Company: Sanofi
Dosage: 200mg, 300mg and 500mg
Contingency Plan:
Update 9/9/19: "Our main priority is to ensure people in the UK have continued access to the medicines and vaccines they need. The uncertainty in the Brexit negotiations means that Sanofi has been planning for a ‘no deal’ scenario, as recommended by the European Federation of Pharmaceutical Industries and Associations (EFPIA). This has involved working across many areas of the Sanofi business, since early 2017.
We have made arrangements for additional warehouse capacity in the UK to stockpile our products, but we are only able to stockpile medicines and vaccines where global supply allows. For the vast majority of our medicines and vaccines, we’ve added six weeks of stock to our business as usual levels, but valproate is an exception due to a manufacturing disruption last summer.
Sanofi has, however, prioritised valproate supply to the UK as part of our ‘no deal’ preparations. It is important to point out that stockpiling is just one of the mechanisms for ensuring we can supply medicines and vaccines in the UK following a ‘no deal’ departure from the EU. We are now operating additional ferry routes into the country and have secured air freight routes as a further contingency should it be required."
Below is the response to the first Brexit date of 29 March 2019:
"Sanofi welcomes the UK Government’s guidance in the event of no deal in the Brexit negotiations published on 23 August. Sanofi is confident that its existing contingency plans will ensure that people in the UK can access the treatments they need after the UK leaves the European Union. However, we have reviewed our stockpiling plans to meet the Government’s specific guidance to increase UK stock by 6 weeks over existing arrangements".
Epilim Chronosphere (sodium valproate) sachets
Company: Sanofi
Dosage: 50mg, 100mg, 250mg, 500mg, 700mg and 1000mg.
Contingency Plan:
Update 9/9/19: "Our main priority is to ensure people in the UK have continued access to the medicines and vaccines they need. The uncertainty in the Brexit negotiations means that Sanofi has been planning for a ‘no deal’ scenario, as recommended by the European Federation of Pharmaceutical Industries and Associations (EFPIA). This has involved working across many areas of the Sanofi business, since early 2017.
We have made arrangements for additional warehouse capacity in the UK to stockpile our products, but we are only able to stockpile medicines and vaccines where global supply allows. For the vast majority of our medicines and vaccines, we’ve added six weeks of stock to our business as usual levels, but valproate is an exception due to a manufacturing disruption last summer.
Sanofi has, however, prioritised valproate supply to the UK as part of our ‘no deal’ preparations. It is important to point out that stockpiling is just one of the mechanisms for ensuring we can supply medicines and vaccines in the UK following a ‘no deal’ departure from the EU. We are now operating additional ferry routes into the country and have secured air freight routes as a further contingency should it be required."
Below is the response to the first Brexit date of 29 March 2019:
"Sanofi welcomes the UK Government’s guidance in the event of no deal in the Brexit negotiations published on 23 August. Sanofi is confident that its existing contingency plans will ensure that people in the UK can access the treatments they need after the UK leaves the European Union. However, we have reviewed our stockpiling plans to meet the Government’s specific guidance to increase UK stock by 6 weeks over existing arrangements".
Episenta (sodium valproate) capsules
Company: Desitin Pharma
Dosage: 150mg and 300mg
Contingency Plan:
Update 12/9/19: "Desitin Pharma has in place plans to manufacture and hold in the UK, by the end of October 2019, 6 months' safety stock of anti-epileptic medication."
Below is the response prior to the first Brexit date of 29 March 2019:
"Desitin Pharma has in place plans to manufacture and hold in the UK, by the beginning of March 2019, 6 months' safety stock of anti-epileptic medication."
Episenta (sodium valproate) granules
Company: Desitin Pharma
Dosage: 500mg and 1000mg
Contingency Plan:
Update 12/9/19: "Desitin Pharma has in place plans to manufacture and hold in the UK, by the end of October 2019, 6 months' safety stock of anti-epileptic medication."
Below is the response prior to the first Brexit date of 29 March 2019:
"Desitin Pharma has in place plans to manufacture and hold in the UK, by the beginning of March 2019, 6 months' safety stock of anti-epileptic medication."
Episenta (sodium valproate) solution for injection or infusion
Company: Desitin Pharma
Dosage: 100mg/ml
Contingency Plan:
Update 12/9/19: "Desitin Pharma has in place plans to manufacture and hold in the UK, by the end of October 2019, 6 months' safety stock of anti-epileptic medication."
Below is the response prior to the first Brexit date of 29 March 2019:
"Desitin Pharma has in place plans to manufacture and hold in the UK, by the beginning of March 2019, 6 months' safety stock of anti-epileptic medication."
Epival (sodium valproate) tablets
Company: Gerot Lannach
Dosage: 300mg
Contingency Plan:
Update 5/9/19: "Based on the information we have from our partners - Pfizer and Healthcare Pharma, they have planned their orders and deliveries in a way to avoid shortages of Epival."
Below is the response to the first Brexit date of 29 March 2019:
"Our distribution partner, Chanelle Medical UK Ltd, have informed us that they have planned for their stock at Brexit to give six months coverage at average demand" - Lisa Kock-Stuppnik, Marketing and Sales International at Gerot Lannach.
Ethosuximide capsules
Company: Essential Pharma
Dosage: 250mg
Contingency Plan:
Update 5/9/19: "I can confirm that Ethosuximide 250mg capsules and Ethosuximide 250mg/5ml syrup will remain in continued supply throughout Brexit."
Below is the response to the first Brexit date of 29 March 2019:
“Oral preparations of ethosuximide will remain in continued supply before and after the 29th March 2019 Brexit date; confirmed by manufacturer”.
Ethosuximide syrup
Company: Essential Pharma
Dosage: 250mg/5ml
Contingency Plan:
Update 5/9/19: "I can confirm that Ethosuximide 250mg capsules and Ethosuximide 250mg/5ml syrup will remain in continued supply throughout Brexit."
Below is the response to the first Brexit date of 29 March 2019:
“Oral preparations of ethosuximide will remain in continued supply before and after the 29th March 2019 Brexit date; confirmed by manufacturer”.
Frisium (clobazam) tablets
Company: Sanofi
Dosage: 10mg
Contingency Plan:
Update 9/9/19: "Our main priority is to ensure people in the UK have continued access to the medicines and vaccines they need. The uncertainty in the Brexit negotiations means that Sanofi has been planning for a ‘no deal’ scenario, as recommended by the European Federation of Pharmaceutical Industries and Associations (EFPIA). This has involved working across many areas of the Sanofi business, since early 2017.
We have made arrangements for additional warehouse capacity in the UK to stockpile our products, but we are only able to stockpile medicines and vaccines where global supply allows. For the vast majority of our medicines and vaccines, we’ve added six weeks of stock to our business as usual levels, but valproate is an exception due to a manufacturing disruption last summer.
Sanofi has, however, prioritised valproate supply to the UK as part of our ‘no deal’ preparations. It is important to point out that stockpiling is just one of the mechanisms for ensuring we can supply medicines and vaccines in the UK following a ‘no deal’ departure from the EU. We are now operating additional ferry routes into the country and have secured air freight routes as a further contingency should it be required."
Below is the response to the first Brexit date of 29 March 2019:
"Sanofi welcomes the UK Government’s guidance in the event of no deal in the Brexit negotiations published on 23 August. Sanofi is confident that its existing contingency plans will ensure that people in the UK can access the treatments they need after the UK leaves the European Union. However, we have reviewed our stockpiling plans to meet the Government’s specific guidance to increase UK stock by 6 weeks over existing arrangements."
Fycompa (perampanel) tablets
Company: Eisai
Dosage: 2mg, 4mg, 6mg, 8mg, 10mg and 12mg
Contingency Plan:
Update 11/9/19: "As a human health care company, Eisai gives first thoughts to patients and their families in all the decisions we make and our approach to Brexit is no exception. As indicated previously, we are doing everything we can to prevent shortages of all our medicines in the event of a no-deal Brexit and have been planning for this for quite some time now. The challenge is that there are some things outside of our control – for example what happens at the border. However, as a responsible pharmaceutical company we have been building additional stocks of medicines, including our anti-epileptic drugs, to make sure that throughout the supply chain we have medicines in the right place and that they can be accessed by the relevant patients. In fact the Eisai stock levels are above the levels that were requested by the Government."
Below is the response to the first Brexit date of 29 March 2019:
"The Eisai stock levels are well above the levels that were requested by the Government."
Gabitril (tiagabine) tablets
Company: Teva UK
Dosage: 5mg, 10mg and 15mg
Contingency Plan:
Update 9/9/19: "The Brexit negotiations between the UK government and the European Union are still ongoing, and the outcome of these remains unknown. At present we are unable to provide specific assurances on the drug your enquiry relates to and we appreciate that you may find this frustrating. However like other pharmaceutical companies in the UK, we have been working very closely with the Department of Health for many months to ensure our patients will continue to receive the medication they need if the UK leaves the EU without a deal. The government has made plans to reduce the risk of disruption and, for our part, we are making sure that we have adequate stocks to cope with any potential border delays.
The message from the government is that if your doctor prescribes you with medicines or special equipment for a health condition, you should still be able to get the treatment you need from your prescriber or pharmacist. Occasionally, there are temporary shortages of specific medicines and if this happens after Brexit, the advice will remain as it currently is; that patients should visit their doctor to be advised with regards to the best alternative treatment for their condition.
We have a team of people from across our business planning for Brexit and our aim is to remain a strong partner to the NHS and stay committed to supplying our medications to the UK and to the patients who depend on us."
Below is the response to the first Brexit date of 29 March 2019:
"We are in very close contact with all the relevant authorities and our aim is to ensure that medicines continue to be available without disruption after Brexit. In the meantime, we remain a strong partner to the NHS and are committed to supplying the UK and the patients who depend on us."
Inovelon (rufinamide) tablets
Company: Eisai
Dosage: 100mg, 200mg and 400mg
Contingency Plan:
Update 11/9/19: "As a human health care company, Eisai gives first thoughts to patients and their families in all the decisions we make and our approach to Brexit is no exception. As indicated previously, we are doing everything we can to prevent shortages of all our medicines in the event of a no-deal Brexit and have been planning for this for quite some time now. The challenge is that there are some things outside of our control – for example what happens at the border. However, as a responsible pharmaceutical company we have been building additional stocks of medicines, including our anti-epileptic drugs, to make sure that throughout the supply chain we have medicines in the right place and that they can be accessed by the relevant patients. In fact the Eisai stock levels are above the levels that were requested by the Government."
Below is the response to the first Brexit date of 29 March 2019:
"The Eisai stock levels are well above the levels that were requested by the Government."
Inovelon (rufinamide) oral suspension
Company: Eisai
Dosage: 40mg/ml
Contingency Plan:
Update 11/9/19: "As a human health care company, Eisai gives first thoughts to patients and their families in all the decisions we make and our approach to Brexit is no exception. As indicated previously, we are doing everything we can to prevent shortages of all our medicines in the event of a no-deal Brexit and have been planning for this for quite some time now. The challenge is that there are some things outside of our control – for example what happens at the border. However, as a responsible pharmaceutical company we have been building additional stocks of medicines, including our anti-epileptic drugs, to make sure that throughout the supply chain we have medicines in the right place and that they can be accessed by the relevant patients. In fact the Eisai stock levels are above the levels that were requested by the Government."
Below is the response to the first Brexit date of 29 March 2019:
"The Eisai stock levels are well above the levels that were requested by the Government."
Keppra (levetiracetam) oral solution
Company: UCB Pharma
Dosage: 100mg/ml
Contingency Plan:
Update 9/9/19: "Following the update we gave you in March, we are in a much better position with stock holding now as follows with no disruptions for the UK anticipated:
Keppra – Average stock holding 5 months
Vimpat – Average stock holding 5 months
Briviact – Average stock holding 6 months
Nootropil – Average stock holding 4 months"
Below is the response to the first Brexit date of 29 March 2019:
"Ensuring patients avoid any disruption to the supply of their medicines is a primary priority for UCB, and as a precautionary measure UCB is increasing stockholding of our core medicines in the UK to cover a 2-month supply period for all products, and a 3-month supply period for many of our medicines to mitigate any potential disruption in a “hard” / “no deal” Brexit scenario.
For UCBs’ AEDs there will be a 2 month supply cover for Keppra (Levetiracetam) in the UK, and a 3-month supply period for Briviact (Brivaracetam), Vimpat (Lacosamide) and Nootropil (Piracetam).
The Medicines Supply Contingency Planning Department for the Department of Health has requested all UK pharma companies to increase their stock holding by 6 weeks (on top of their existing safety stock) to cover the impact of a ‘hard’ Brexit, which UCB has complied with. In addition, the UK Government announced that in the event of a “hard” / “no deal” Brexit many important elements and processes relating to the supply chain for medicines coming to the UK from the EU will remain the same as they are today after March 29th 2019, and that the Government would give pharmaceutical manufacturers at least 2 years notice before any proposed changes to this would be considered.
Because avoiding disruption to patients is a key priority for UCB, we continue to actively and routinely engage UK Government to encourage the development of policies that will avoid disruption to UK patients receiving their medicines."
Keppra (levetiracetam) tablets
Company: UCB Pharma
Dosage: 250mg, 500mg, 750mg and 1000mg
Contingency Plan:
Update 9/9/19: "Following the update we gave you in March, we are in a much better position with stock holding now as follows with no disruptions for the UK anticipated:
Keppra – Average stock holding 5 months
Vimpat – Average stock holding 5 months
Briviact – Average stock holding 6 months
Nootropil – Average stock holding 4 months"
Below is the response to the first Brexit date of 29 March 2019:
"Ensuring patients avoid any disruption to the supply of their medicines is a primary priority for UCB, and as a precautionary measure UCB is increasing stockholding of our core medicines in the UK to cover a 2-month supply period for all products, and a 3-month supply period for many of our medicines to mitigate any potential disruption in a “hard” / “no deal” Brexit scenario.
For UCBs’ AEDs there will be a 2 month supply cover for Keppra (Levetiracetam) in the UK, and a 3-month supply period for Briviact (Brivaracetam), Vimpat (Lacosamide) and Nootropil (Piracetam).
The Medicines Supply Contingency Planning Department for the Department of Health has requested all UK pharma companies to increase their stock holding by 6 weeks (on top of their existing safety stock) to cover the impact of a ‘hard’ Brexit, which UCB has complied with. In addition, the UK Government announced that in the event of a “hard” / “no deal” Brexit many important elements and processes relating to the supply chain for medicines coming to the UK from the EU will remain the same as they are today after March 29th 2019, and that the Government would give pharmaceutical manufacturers at least 2 years notice before any proposed changes to this would be considered.
Because avoiding disruption to patients is a key priority for UCB, we continue to actively and routinely engage UK Government to encourage the development of policies that will avoid disruption to UK patients receiving their medicines."
Lamictal (lamotrigine) dispersible tablets
Company: Glaxo-Smith Kline (GSK)
Dosage: 2mg, 5mg, 25mg and 100mg
Contingency Plan:
Update 23/9/19: "Throughout the Brexit process, GSK’s priority has been to maintain the continuity of supply of medicines, vaccines and healthcare products for patients and consumers. To minimise the potential for disruption to supply when the UK exits the EU, we started preparing for Brexit immediately following the referendum result. We took a risk-based approach to mitigation, preparing for all scenarios including no deal.
The bulk of our new post-Brexit operating model is now in place, and arrangements linked to customs and borders are ready to be implemented as the UK leaves the EU. There is a fair amount of detail outlined in our annual report (p36) on the specific activities we undertook, including expanding our ability to conduct re-testing and certification of medicines, amending manufacturing and importation licences, updating packaging, securing additional warehousing and transferring Marketing Authorisation Holders to EU regulators for EU supply. Our operating model includes robust forecasting, control of our stock and additional warehouse capacity in the UK. We have adjusted safety stock levels and identified alternative transportation routes that avoid the busy short straits crossing between the UK and EU, which we’ll utilise to mitigate for potential disruption at the EU/UK borders around Brexit date.
Supply continuity has been and continues to be our overriding priority and we are confident we have done everything in our control to prepare for Brexit. Our plans are being kept under constant review, including at an individual product level, as the Brexit process continues. We have extensive experience managing our complex supply chains and we are taking mitigating action around products that may be affected. Where we anticipate issues, we will inform the regulator at the earliest opportunity."
Below is the response to the first Brexit date of 29 March 2019:
"Until there is formal agreement, we will continue to implement our contingency plans for all scenarios, including no deal."
Lamictal (lamotrigine) tablets
Company: Glaxo-Smith Kline (GSK)
Dosage: 25mg, 50mg, 100mg and 200mg
Contingency Plan:
Update 23/9/19: "Throughout the Brexit process, GSK’s priority has been to maintain the continuity of supply of medicines, vaccines and healthcare products for patients and consumers. To minimise the potential for disruption to supply when the UK exits the EU, we started preparing for Brexit immediately following the referendum result. We took a risk-based approach to mitigation, preparing for all scenarios including no deal.
The bulk of our new post-Brexit operating model is now in place, and arrangements linked to customs and borders are ready to be implemented as the UK leaves the EU. There is a fair amount of detail outlined in our annual report (p36) on the specific activities we undertook, including expanding our ability to conduct re-testing and certification of medicines, amending manufacturing and importation licences, updating packaging, securing additional warehousing and transferring Marketing Authorisation Holders to EU regulators for EU supply. Our operating model includes robust forecasting, control of our stock and additional warehouse capacity in the UK. We have adjusted safety stock levels and identified alternative transportation routes that avoid the busy short straits crossing between the UK and EU, which we’ll utilise to mitigate for potential disruption at the EU/UK borders around Brexit date.
Supply continuity has been and continues to be our overriding priority and we are confident we have done everything in our control to prepare for Brexit. Our plans are being kept under constant review, including at an individual product level, as the Brexit process continues. We have extensive experience managing our complex supply chains and we are taking mitigating action around products that may be affected. Where we anticipate issues, we will inform the regulator at the earliest opportunity."
Below is the response to the first Brexit date of 29 March 2019:
"Until there is formal agreement, we will continue to implement our contingency plans for all scenarios, including no deal."
Lyrica (pregabalin) capsules
Company: Pfizer
Dosage: 25mg, 50mg, 75mg, 100mg, 150mg, 200mg, 225mg and 300mg
Contingency Plan:
Update 9/9/19: "Our overriding priorities are to ensure continued patient access to medicines and vaccines, avoiding any disruption to existing quality control arrangements and to the supply of medicines and vaccines to patients. We have undertaken work to ensure we can continue to supply in the EU and the UK in all Brexit outcome scenarios and are taking into account UK Government guidance on medicine and vaccine supplies in preparation for the UK leaving the EU under a “no deal” scenario. While plans are in place to ensure continuity of supply, there remains a dependency on external supplier readiness. Pfizer is working with external suppliers to ensure alignment."
Below is the response to the first Brexit date of 29 March 2019:
"In order to minimize any potential patient impact we have undertaken work to ensure we can continue to supply in the EU and the UK covering all Brexit scenarios. We have carried out detailed assessments of the supply of all our medicines with the focus on ensuring we will continue to have them available for our patients. Due to the long lead times we have in our supply chains, and in the interests of all patients across Europe, we are asking the EU and the UK to reach appropriate arrangements for alignment and cooperation for medicines regulation and supply, and to support these alongside other elements to foster longer-term regulatory continuity between the EU and UK."
Lyrica (pregabalin) oral solution
Company: Pfzier
Dosage: 20mg/ml
Contingency Plan:
Update 9/9/19: "Our overriding priorities are to ensure continued patient access to medicines and vaccines, avoiding any disruption to existing quality control arrangements and to the supply of medicines and vaccines to patients. We have undertaken work to ensure we can continue to supply in the EU and the UK in all Brexit outcome scenarios and are taking into account UK Government guidance on medicine and vaccine supplies in preparation for the UK leaving the EU under a “no deal” scenario. While plans are in place to ensure continuity of supply, there remains a dependency on external supplier readiness. Pfizer is working with external suppliers to ensure alignment."
Below is the response to the first Brexit date of 29 March 2019:
"In order to minimize any potential patient impact we have undertaken work to ensure we can continue to supply in the EU and the UK covering all Brexit scenarios. We have carried out detailed assessments of the supply of all our medicines with the focus on ensuring we will continue to have them available for our patients. Due to the long lead times we have in our supply chains, and in the interests of all patients across Europe, we are asking the EU and the UK to reach appropriate arrangements for alignment and cooperation for medicines regulation and supply, and to support these alongside other elements to foster longer-term regulatory continuity between the EU and UK."
Neurontin (gabapentin) tablets
Company: Pfizer
Dosage: 600mg and 800mg
Contingency Plan:
Update 9/9/19: "Our overriding priorities are to ensure continued patient access to medicines and vaccines, avoiding any disruption to existing quality control arrangements and to the supply of medicines and vaccines to patients. We have undertaken work to ensure we can continue to supply in the EU and the UK in all Brexit outcome scenarios and are taking into account UK Government guidance on medicine and vaccine supplies in preparation for the UK leaving the EU under a “no deal” scenario. While plans are in place to ensure continuity of supply, there remains a dependency on external supplier readiness. Pfizer is working with external suppliers to ensure alignment.
Below is the response to the first Brexit date of 29 March 2019:
"In order to minimize any potential patient impact we have undertaken work to ensure we can continue to supply in the EU and the UK covering all Brexit scenarios. We have carried out detailed assessments of the supply of all our medicines with the focus on ensuring we will continue to have them available for our patients. Due to the long lead times we have in our supply chains, and in the interests of all patients across Europe, we are asking the EU and the UK to reach appropriate arrangements for alignment and cooperation for medicines regulation and supply, and to support these alongside other elements to foster longer-term regulatory continuity between the EU and UK."
Neurontin (gabapentin) capsules
Company: Pfizer
Dosage: 100mg, 300mg and 400mg
Contingency Plan:
Update 9/9/19: "Our overriding priorities are to ensure continued patient access to medicines and vaccines, avoiding any disruption to existing quality control arrangements and to the supply of medicines and vaccines to patients. We have undertaken work to ensure we can continue to supply in the EU and the UK in all Brexit outcome scenarios and are taking into account UK Government guidance on medicine and vaccine supplies in preparation for the UK leaving the EU under a “no deal” scenario. While plans are in place to ensure continuity of supply, there remains a dependency on external supplier readiness. Pfizer is working with external suppliers to ensure alignment."
Below is the response to the first Brexit date of 29 March 2019:
"In order to minimize any potential patient impact we have undertaken work to ensure we can continue to supply in the EU and the UK covering all Brexit scenarios. We have carried out detailed assessments of the supply of all our medicines with the focus on ensuring we will continue to have them available for our patients. Due to the long lead times we have in our supply chains, and in the interests of all patients across Europe, we are asking the EU and the UK to reach appropriate arrangements for alignment and cooperation for medicines regulation and supply, and to support these alongside other elements to foster longer-term regulatory continuity between the EU and UK."
Nootropil (piracetam) tablets
Company: UCB Pharma
Dosage: 800mg and 1200mg
Contingency Plan:
Update 9/9/19: "Following the update we gave you in March, we are in a much better position with stock holding now as follows with no disruptions for the UK anticipated:
Keppra – Average stock holding 5 months
Vimpat – Average stock holding 5 months
Briviact – Average stock holding 6 months
Nootropil – Average stock holding 4 months"
Below is the response to the first Brexit date of 29 March 2019:
"Ensuring patients avoid any disruption to the supply of their medicines is a primary priority for UCB, and as a precautionary measure UCB is increasing stockholding of our core medicines in the UK to cover a 2-month supply period for all products, and a 3-month supply period for many of our medicines to mitigate any potential disruption in a “hard” / “no deal” Brexit scenario.
For UCBs’ AEDs there will be a 2 month supply cover for Keppra (Levetiracetam) in the UK, and a 3-month supply period for Briviact (Brivaracetam), Vimpat (Lacosamide) and Nootropil (Piracetam).
The Medicines Supply Contingency Planning Department for the Department of Health has requested all UK pharma companies to increase their stock holding by 6 weeks (on top of their existing safety stock) to cover the impact of a ‘hard’ Brexit, which UCB has complied with. In addition, the UK Government announced that in the event of a “hard” / “no deal” Brexit many important elements and processes relating to the supply chain for medicines coming to the UK from the EU will remain the same as they are today after March 29th 2019, and that the Government would give pharmaceutical manufacturers at least 2 years notice before any proposed changes to this would be considered.
Because avoiding disruption to patients is a key priority for UCB, we continue to actively and routinely engage UK Government to encourage the development of policies that will avoid disruption to UK patients receiving their medicines."
Nootropil (piracetam) solution
Company: UCB Pharma
Dosage: 333.3mg/ml
Contingency Plan:
Update 9/9/19: "Following the update we gave you in March, we are in a much better position with stock holding now as follows with no disruptions for the UK anticipated:
Keppra – Average stock holding 5 months
Vimpat – Average stock holding 5 months
Briviact – Average stock holding 6 months
Nootropil – Average stock holding 4 months"
Below is the response to the first Brexit date of 29 March 2019:
"Ensuring patients avoid any disruption to the supply of their medicines is a primary priority for UCB, and as a precautionary measure UCB is increasing stockholding of our core medicines in the UK to cover a 2-month supply period for all products, and a 3-month supply period for many of our medicines to mitigate any potential disruption in a “hard” / “no deal” Brexit scenario.
For UCBs’ AEDs there will be a 2 month supply cover for Keppra (Levetiracetam) in the UK, and a 3-month supply period for Briviact (Brivaracetam), Vimpat (Lacosamide) and Nootropil (Piracetam).
The Medicines Supply Contingency Planning Department for the Department of Health has requested all UK pharma companies to increase their stock holding by 6 weeks (on top of their existing safety stock) to cover the impact of a ‘hard’ Brexit, which UCB has complied with. In addition, the UK Government announced that in the event of a “hard” / “no deal” Brexit many important elements and processes relating to the supply chain for medicines coming to the UK from the EU will remain the same as they are today after March 29th 2019, and that the Government would give pharmaceutical manufacturers at least 2 years notice before any proposed changes to this would be considered.
Because avoiding disruption to patients is a key priority for UCB, we continue to actively and routinely engage UK Government to encourage the development of policies that will avoid disruption to UK patients receiving their medicines."
Perizam (clobazam) tablets
Company: Auden McKenzie (now Accord Healthcare)
Dosage: 10mg
Contingency Plan:
Update 13/9/19: "Accord Healthcare is dedicated to ensuring UK and European patients have access to high-quality, affordable medicines. Since the Brexit referendum, we've worked hard on executing plans to ensure continuity of supply of medicines to healthcare systems. As a result, Accord Healthcare will continue to supply our European and UK patients as we do today and expect minimal impact, whatever Brexit scenario we face. We've also worked with various partners including the UK Department of Health and Social Care (DHSC) around planning contingency stocks and other materials in our facilities. It's part of several measures we have in place to ensure that healthcare professionals and patients continue to receive medicines."
Phenobarbital tablets
Company: Teva UK
Dosage: 15mg, 30mg and 60mg
Contingency Plan:
Update 9/9/19: "The Brexit negotiations between the UK government and the European Union are still ongoing, and the outcome of these remains unknown. At present we are unable to provide specific assurances on the drug your enquiry relates to and we appreciate that you may find this frustrating. However like other pharmaceutical companies in the UK, we have been working very closely with the Department of Health for many months to ensure our patients will continue to receive the medication they need if the UK leaves the EU without a deal. The government has made plans to reduce the risk of disruption and, for our part, we are making sure that we have adequate stocks to cope with any potential border delays.
The message from the government is that if your doctor prescribes you with medicines or special equipment for a health condition, you should still be able to get the treatment you need from your prescriber or pharmacist. Occasionally, there are temporary shortages of specific medicines and if this happens after Brexit, the advice will remain as it currently is; that patients should visit their doctor to be advised with regards to the best alternative treatment for their condition.
We have a team of people from across our business planning for Brexit and our aim is to remain a strong partner to the NHS and stay committed to supplying our medications to the UK and to the patients who depend on us."
Below is the response to the first Brexit date of 29 March 2019:
"We are in very close contact with all the relevant authorities and our aim is to ensure that medicines continue to be available without disruption after Brexit. In the meantime, we remain a strong partner to the NHS and are committed to supplying the UK and the patients who depend on us."
Phenobarbital Elixir
Company: Thornton & Ross Limited
Dosage: 15mg/5ml
Contingency Plan: "We do not currently anticipate problems as many of our products are made on site for the UK market and we currently have adequate stocks of raw materials for production."
Phenytoin sodium capsules
Company: Flynn Pharma
Dosage: 25mg, 50mg, 100mg and 300mg
Contingency Plan:
Update 5/9/19: "Flynn’s position, unlike Government/Parliament in regard to Brexit, has not changed from that we outlined in our reply to the Epilepsy Society’s email of December 2018 on the same matter. We totally understand and share your interest and the concerns of individual patients and their families for whom continuous supply and access to AEDs is all-important. Flynn continues to hold and maintain good levels of safety stock for each of the four strengths we supply."
Below is the response to the first Brexit date of 29 March 2019:
"We hold and have good access to safety stocks of all strengths of the product in the UK and will continue to do so, increasing those stocks ahead of ‘Brexit’ if required. Demand is monitored on a daily basis."
Primidone tablets
Company: Teva UK
Dosage: 50mg and 250mg
Contingency Plan:
Update 9/9/19: "The Brexit negotiations between the UK government and the European Union are still ongoing, and the outcome of these remains unknown. At present we are unable to provide specific assurances on the drug your enquiry relates to and we appreciate that you may find this frustrating. However like other pharmaceutical companies in the UK, we have been working very closely with the Department of Health for many months to ensure our patients will continue to receive the medication they need if the UK leaves the EU without a deal. The government has made plans to reduce the risk of disruption and, for our part, we are making sure that we have adequate stocks to cope with any potential border delays.
The message from the government is that if your doctor prescribes you with medicines or special equipment for a health condition, you should still be able to get the treatment you need from your prescriber or pharmacist. Occasionally, there are temporary shortages of specific medicines and if this happens after Brexit, the advice will remain as it currently is; that patients should visit their doctor to be advised with regards to the best alternative treatment for their condition.
We have a team of people from across our business planning for Brexit and our aim is to remain a strong partner to the NHS and stay committed to supplying our medications to the UK and to the patients who depend on us."
Below is the response to the first Brexit date of 29 March 2019:
"We are in very close contact with all the relevant authorities and our aim is to ensure that medicines continue to be available without disruption after Brexit. In the meantime, we remain a strong partner to the NHS and are committed to supplying the UK and the patients who depend on us".
Sabril (vigabatrin) tablets
Company: Sanofi
Dosage: 500mg
Contingency Plan:
Update 9/9/19: "Our main priority is to ensure people in the UK have continued access to the medicines and vaccines they need. The uncertainty in the Brexit negotiations means that Sanofi has been planning for a ‘no deal’ scenario, as recommended by the European Federation of Pharmaceutical Industries and Associations (EFPIA). This has involved working across many areas of the Sanofi business, since early 2017.
We have made arrangements for additional warehouse capacity in the UK to stockpile our products, but we are only able to stockpile medicines and vaccines where global supply allows. For the vast majority of our medicines and vaccines, we’ve added six weeks of stock to our business as usual levels, but valproate is an exception due to a manufacturing disruption last summer.
Sanofi has, however, prioritised valproate supply to the UK as part of our ‘no deal’ preparations. It is important to point out that stockpiling is just one of the mechanisms for ensuring we can supply medicines and vaccines in the UK following a ‘no deal’ departure from the EU. We are now operating additional ferry routes into the country and have secured air freight routes as a further contingency should it be required."
Below is the response to the first Brexit date of 29 March 2019:
"Sanofi welcomes the UK Government’s guidance in the event of no deal in the Brexit negotiations published on 23 August. Sanofi is confident that its existing contingency plans will ensure that people in the UK can access the treatments they need after the UK leaves the European Union. However, we have reviewed our stockpiling plans to meet the Government’s specific guidance to increase UK stock by 6 weeks over existing arrangements".
Sabril (vigabatrin) powder for oral solution
Company: Sanofi
Dosage: 500mg
Contingency Plan:
Update 9/9/19: "Our main priority is to ensure people in the UK have continued access to the medicines and vaccines they need. The uncertainty in the Brexit negotiations means that Sanofi has been planning for a ‘no deal’ scenario, as recommended by the European Federation of Pharmaceutical Industries and Associations (EFPIA). This has involved working across many areas of the Sanofi business, since early 2017.
We have made arrangements for additional warehouse capacity in the UK to stockpile our products, but we are only able to stockpile medicines and vaccines where global supply allows. For the vast majority of our medicines and vaccines, we’ve added six weeks of stock to our business as usual levels, but valproate is an exception due to a manufacturing disruption last summer.
Sanofi has, however, prioritised valproate supply to the UK as part of our ‘no deal’ preparations. It is important to point out that stockpiling is just one of the mechanisms for ensuring we can supply medicines and vaccines in the UK following a ‘no deal’ departure from the EU. We are now operating additional ferry routes into the country and have secured air freight routes as a further contingency should it be required."
Below is the response to the first Brexit date of 29 March 2019:
"Sanofi welcomes the UK Government’s guidance in the event of no deal in the Brexit negotiations published on 23 August. Sanofi is confident that its existing contingency plans will ensure that people in the UK can access the treatments they need after the UK leaves the European Union. However, we have reviewed our stockpiling plans to meet the Government’s specific guidance to increase UK stock by 6 weeks over existing arrangements".
Tapclob (clobazam) oral suspension
Company: Martindale Pharma
Dosage: 5mg/5ml, 150ml and 250ml bottles
Contingency Plan: "I can confirm that all lines of Tapclob, 5mg/5ml 150ml and 250ml bottles and 10mg/5ml 150ml and 250ml bottles, are UK sourced lines that are manufactured and packed in the UK and therefore, we are anticipating minimal impact on the supply of these products. However, we are working closely with our suppliers of materials and components to ensure that we have safety stocks in place ahead of the March 2019 deadline".
Tapclob (clobazam) oral suspension
Company: Martindale Pharma
Dosage: 10mg/5ml, 150ml and 250ml bottles
Contingency Plan: "I can confirm that all lines of Tapclob, 5mg/5ml 150ml and 250ml bottles and 10mg/5ml 150ml and 250ml bottles, are UK sourced lines that are manufactured and packed in the UK and therefore, we are anticipating minimal impact on the supply of these products. However, we are working closely with our suppliers of materials and components to ensure that we have safety stocks in place ahead of the March 2019 deadline".
Tegretol (carbamazepine) liquid
Company: Novartis UK
Dosage: 100mg/5ml
Contingency Plan:
Update 5/9/19: "Our priority is to make sure patients can continue to access their medicines in any post-Brexit scenario. We are continuing to implement contingency plans to ensure continuity of supply to patients in the UK in the event of a no-deal Brexit. This includes holding increased inventories across our medicines portfolio for both Novartis and Sandoz. Our contingency plans also involve introducing alternate supply routes to help avoid any delays at the usual points of entry and Novartis has Authorized Economic Operator (AEO) accreditation, which gives quicker access to certain simplified customs procedures and in some cases the right to fast-track shipments."
Below is the response to the first Brexit date of 29 March 2019:
"Will meet Government’s specific guidance to increase UK stock by 6 weeks over existing arrangements."
Tegretol (carbamazepine) prolonged release tablets
Company: Novartis UK
Dosage: 200mg
Updated information: Due to some preparations of Carbagen (carbamazepine) manufactured by Mylan being unavailable until mid-late 2019, Novartis, which is the alternative brand of carbamazepine tablets, have confirmed that they are able to support additional demand during this time for all affected strengths and formulations.
Contingency Plan:
Update 5/9/19: "Our priority is to make sure patients can continue to access their medicines in any post-Brexit scenario. We are continuing to implement contingency plans to ensure continuity of supply to patients in the UK in the event of a no-deal Brexit. This includes holding increased inventories across our medicines portfolio for both Novartis and Sandoz. Our contingency plans also involve introducing alternate supply routes to help avoid any delays at the usual points of entry and Novartis has Authorized Economic Operator (AEO) accreditation, which gives quicker access to certain simplified customs procedures and in some cases the right to fast-track shipments."
Below is the response to the first Brexit date of 29 March 2019:
"Will meet Government’s specific guidance to increase UK stock by 6 weeks over existing arrangements."
Topamax (topiramate) tablets
Company: Janssen Cilag
Dosage: 25mg, 50mg, 100mg and 200mg
Contingency Plan:
Update 9/9/19: At Janssen, our first priority is to patients. For more than two years, we have been preparing for a variety of Brexit scenarios and have taken the necessary steps, in collaboration with our partners, to help ensure that patients in the UK have ongoing access to our medicines. In addition to following the stockpile guidance issued by the Government, Janssen has gone above and beyond by:
- Moving products intended for the UK market to dedicated UK distribution centres, to minimise the impact of possible border delays
- Sourcing additional warehouse space to accommodate these extra medicines now located in the UK
- Identifying and implementing alternative distribution routes to avoid potential delays at the Calais/Folkstone ports
While we maintain that leaving the European Union without securing a deal on 31st October would be extremely challenging for the pharmaceutical industry – Janssen will continue to do everything within our control, to minimise any Brexit-related interruption to the supply of our medicines, for patients and their families in the UK."
Please see more updates on Janssen-Cilag's Brexit preparations: https://www.janssen.com/uk/brexit-preparations.
Below is the response to the first Brexit date of 29 March 2019:
"Will meet Government’s specific guidance to increase UK stock by 6 weeks over existing arrangements."
Topamax (topiramate) sprinkle capsules
Company: Janssen Cilag
Dosage: 15mg, 25mg and 50mg
Contingency Plan:
Update 9/9/19: At Janssen, our first priority is to patients. For more than two years, we have been preparing for a variety of Brexit scenarios and have taken the necessary steps, in collaboration with our partners, to help ensure that patients in the UK have ongoing access to our medicines. In addition to following the stockpile guidance issued by the Government, Janssen has gone above and beyond by:
- Moving products intended for the UK market to dedicated UK distribution centres, to minimise the impact of possible border delays
- Sourcing additional warehouse space to accommodate these extra medicines now located in the UK
- Identifying and implementing alternative distribution routes to avoid potential delays at the Calais/Folkstone ports
While we maintain that leaving the European Union without securing a deal on 31st October would be extremely challenging for the pharmaceutical industry – Janssen will continue to do everything within our control, to minimise any Brexit-related interruption to the supply of our medicines, for patients and their families in the UK."
Please see more updates on Janssen-Cilag's Brexit preparations: https://www.janssen.com/uk/brexit-preparations.
Below is the response to the first Brexit date of 29 March 2019:
"Will meet Government’s specific guidance to increase UK stock by 6 weeks over existing arrangements."
Trileptal (oxcarbazepine) tablets
Company: Novartis UK
Dosage: 150mg, 300mg and 600mg
Contingency Plan:
Update 5/9/19: "Our priority is to make sure patients can continue to access their medicines in any post-Brexit scenario. We are continuing to implement contingency plans to ensure continuity of supply to patients in the UK in the event of a no-deal Brexit. This includes holding increased inventories across our medicines portfolio for both Novartis and Sandoz. Our contingency plans also involve introducing alternate supply routes to help avoid any delays at the usual points of entry and Novartis has Authorized Economic Operator (AEO) accreditation, which gives quicker access to certain simplified customs procedures and in some cases the right to fast-track shipments."
Below is the response to the first Brexit date of 29 March 2019:
"Will meet Government’s specific guidance to increase UK stock by 6 weeks over existing arrangements."
Trileptal (oxcarbazepine) oral suspension
Company: Novartis UK
Dosage: 60mg/ml
Contingency Plan:
Update 5/9/19: "Our priority is to make sure patients can continue to access their medicines in any post-Brexit scenario. We are continuing to implement contingency plans to ensure continuity of supply to patients in the UK in the event of a no-deal Brexit. This includes holding increased inventories across our medicines portfolio for both Novartis and Sandoz. Our contingency plans also involve introducing alternate supply routes to help avoid any delays at the usual points of entry and Novartis has Authorized Economic Operator (AEO) accreditation, which gives quicker access to certain simplified customs procedures and in some cases the right to fast-track shipments."
Below is the response to the first Brexit date of 29 March 2019:
"Will meet Government’s specific guidance to increase UK stock by 6 weeks over existing arrangements."
Vimpat (lacosamide) syrup
Company: UCB Pharma
Dosage: 10mg/ml
Contingency Plan:
Update 9/9/19: "Following the update we gave you in March, we are in a much better position with stock holding now as follows with no disruptions for the UK anticipated:
Keppra – Average stock holding 5 months
Vimpat – Average stock holding 5 months
Briviact – Average stock holding 6 months
Nootropil – Average stock holding 4 months"
Below is the response to the first Brexit date of 29 March 2019:
"Ensuring patients avoid any disruption to the supply of their medicines is a primary priority for UCB, and as a precautionary measure UCB is increasing stockholding of our core medicines in the UK to cover a 2-month supply period for all products, and a 3-month supply period for many of our medicines to mitigate any potential disruption in a “hard” / “no deal” Brexit scenario.
For UCBs’ AEDs there will be a 2 month supply cover for Keppra (Levetiracetam) in the UK, and a 3-month supply period for Briviact (Brivaracetam), Vimpat (Lacosamide) and Nootropil (Piracetam).
The Medicines Supply Contingency Planning Department for the Department of Health has requested all UK pharma companies to increase their stock holding by 6 weeks (on top of their existing safety stock) to cover the impact of a ‘hard’ Brexit, which UCB has complied with. In addition, the UK Government announced that in the event of a “hard” / “no deal” Brexit many important elements and processes relating to the supply chain for medicines coming to the UK from the EU will remain the same as they are today after March 29th 2019, and that the Government would give pharmaceutical manufacturers at least 2 years notice before any proposed changes to this would be considered.
Because avoiding disruption to patients is a key priority for UCB, we continue to actively and routinely engage UK Government to encourage the development of policies that will avoid disruption to UK patients receiving their medicines."
Vimpat (lacosamide) tablets
Company: UCB Pharma
Dosage: 50mg, 100mg, 150mg and 200mg
Contingency Plan:
Update 9/9/19: "Following the update we gave you in March, we are in a much better position with stock holding now as follows with no disruptions for the UK anticipated:
Keppra – Average stock holding 5 months
Vimpat – Average stock holding 5 months
Briviact – Average stock holding 6 months
Nootropil – Average stock holding 4 months"
Below is the response to the first Brexit date of 29 March 2019:
"Ensuring patients avoid any disruption to the supply of their medicines is a primary priority for UCB, and as a precautionary measure UCB is increasing stockholding of our core medicines in the UK to cover a 2-month supply period for all products, and a 3-month supply period for many of our medicines to mitigate any potential disruption in a “hard” / “no deal” Brexit scenario.
For UCBs’ AEDs there will be a 2 month supply cover for Keppra (Levetiracetam) in the UK, and a 3-month supply period for Briviact (Brivaracetam), Vimpat (Lacosamide) and Nootropil (Piracetam).
The Medicines Supply Contingency Planning Department for the Department of Health has requested all UK pharma companies to increase their stock holding by 6 weeks (on top of their existing safety stock) to cover the impact of a ‘hard’ Brexit, which UCB has complied with. In addition, the UK Government announced that in the event of a “hard” / “no deal” Brexit many important elements and processes relating to the supply chain for medicines coming to the UK from the EU will remain the same as they are today after March 29th 2019, and that the Government would give pharmaceutical manufacturers at least 2 years notice before any proposed changes to this would be considered.
Because avoiding disruption to patients is a key priority for UCB, we continue to actively and routinely engage UK Government to encourage the development of policies that will avoid disruption to UK patients receiving their medicines."
Zebinix (eslicarbazepine acetate) tablets
Company: Eisai
Dosage: 200mg and 800mg
Contingency Plan:
Update 11/9/19: "As a human health care company, Eisai gives first thoughts to patients and their families in all the decisions we make and our approach to Brexit is no exception. As indicated previously, we are doing everything we can to prevent shortages of all our medicines in the event of a no-deal Brexit and have been planning for this for quite some time now. The challenge is that there are some things outside of our control – for example what happens at the border. However, as a responsible pharmaceutical company we have been building additional stocks of medicines, including our anti-epileptic drugs, to make sure that throughout the supply chain we have medicines in the right place and that they can be accessed by the relevant patients. In fact the Eisai stock levels are above the levels that were requested by the Government."
Below is the response to the first Brexit date of 29 March 2019:
"The Eisai stock levels are well above the levels that were requested by the Government."
Zonegran (zonisamide) capsules
Company: Eisai
Dosage: 25mg, 50mg and 100mg
Contingency Plan:
Update 11/9/19: "As a human health care company, Eisai gives first thoughts to patients and their families in all the decisions we make and our approach to Brexit is no exception. As indicated previously, we are doing everything we can to prevent shortages of all our medicines in the event of a no-deal Brexit and have been planning for this for quite some time now. The challenge is that there are some things outside of our control – for example what happens at the border. However, as a responsible pharmaceutical company we have been building additional stocks of medicines, including our anti-epileptic drugs, to make sure that throughout the supply chain we have medicines in the right place and that they can be accessed by the relevant patients. In fact the Eisai stock levels are above the levels that were requested by the Government."
Below is the response to the first Brexit date of 29 March 2019:
"The Eisai stock levels are well above the levels that were requested by the Government."