The FAMHP wants to inform patients about the possible impact of Brexit on medicines and medical devices available on the Belgian market.
The FAMHP will revise this information as the situation evolves further.
(1) Could Brexit lead to a shortage of certain medicines (for human and veterinary use)?
(2) How many medicines are affected by Brexit?
(3) How will I know whether my medicine will remain available after Brexit?
(4) What should I do if my medicine is not available?
(5) I want to travel to the United Kingdom with medicines for personal use. What should I do?
(6) May I order medicines online from the United Kingdom after Brexit?
(1) Can Brexit lead to a shortage of certain medical devices?
(2) How do I recognize medical devices affected by Brexit?
(3) Is it still safe to use medical devices affected by Brexit?
(4) What must I do if a medical device is not available?
(5) May I purchase medical devices on the internet if the distributor is headquartered in the United Kingdom?
After Brexit, the United Kingdom (UK) will be considered a "third country” by the European Union (EU). In practice, this means that the EU will subject all medicines produced in the UK to additional controls and that the parties responsible for these medicines must revise their licenses. The FAMHP works together on a European level with medicine authorities in other member states and with the European Medicines Agency (EMA) to ensure that all of the companies involved revise their licenses in a timely manner and take the actions necessary so that not only to make sure the obligatory additional controls can take place in the EU, but also to prevent unavailability of medicines on the European market as much as possible.
In recent months, the FAMHP has mapped out the medicines for which availability problems could be expected once Brexit is complete. These medicines will be analysed individually, taking into consideration the number of available alternatives and what the medicine is used for. In this way, a number of medicines will be identified that could be problematic in the event of unavailability. For most medicines, a solution has already been found. For other, a solution is planned.
At the beginning of the Brexit process, the FAMHP identified medicines for which there may be problems regarding availability for Belgian patients.
These medicines will be analysed individually, taking into consideration the number of available alternatives and what the medicine is used for. In this way, a number of medicines that could be problematic in the event of unavailability will be identified. For each drug a solution was found, or a solution is in the works:
- For the majority of these medicines, the affected pharmaceutical companies and authorized institutions have already taken the necessary measures.
- For the remaining medicines, the affected companies have indicated that they will take the necessary actions in time so their products can remain available on the European market.
Within the framework of Brexit, the FAMHP works closely with the affected pharmaceutical companies. This prevents problems with unavailability as much as possible.
On our website you can find a list of all unavailable medicines. Medicines that are not available due to Brexit will be listed in the database.
The FAMHP updates this database daily so that you can always find out if your drug is available.
Despite all preparations, there is a small chance that some medicines will not be available as a result of Brexit (see question 2). In addition, it can of course happen that a medicine is temporarily not available for reasons that have nothing to do with Brexit. In the event of unavailability, it is best to contact your doctor or pharmacist. He or she knows your medical history.
Before your departure, check the British authorized institutions whether the medicines you wish to take with you, are approved for use in the United Kingdom (so-called “controlled drugs”). If that is the case, check the conditions for authorization. Check, for example, whether you need a copy of the prescription, a doctor's statement (in English), a medical certificate, another statement or a special permission and whether the amount of medicines you can bring into the United Kingdom is limited or not.
The FAMHP advises to be extra careful when travelling with specially regulated narcotics (morphine and other opiate analgesics, sedatives …).
No, after Brexit you may not order medicines from online pharmacies or other suppliers based in the United Kingdom and who sell their products on the internet.
British online providers of medicines may no longer fall back on the so-called "country of origin principle” of the European Directive on electronic trade. According to that principle, dealers are not bound to the laws of the country to which they ship their products (or where they offer their products via the internet), but must only adhere to the legislation of the country where they are based. In addition, after Brexit, British providers of medicines must no longer adhere to the requirements regarding online sale of medicines as set forth in Directive 2001/83/EU.
If a seller is headquartered outside of the European Union, every member state has the right to subject the online sale of medicines and health products to their national legislation. Thus the Belgian law dated 25 March 1964 regarding medicines states that distributors may only sell medications for which no prescription is necessary over the internet. The Belgian and European legislation requires online sellers of medicines to place a special logo on their site. This logo proves that the website belongs to an authorized online pharmacy and indicates which European member state has issued the license. This European logo is not required on British websites that sell medicines.
Thus, purchasing and/or importing medicines via British websites is illegal.
You can find more information on the sale of medicines on the internet on our website.
For medical devices that have been brought to market in the EU before Brexit, Brexit will have no consequences. They may be freely traded on the territory of the 27 European member states (EU27). This is not necessarily the case for medical devices that are brought to market in the EU after Brexit. Affected manufacturers who want to offer their products in the EU27, need to make a few changes first.
Certain medical devices which are in higher risk classes must have a CE certificate issued by a registered institution before they can be sold. The certificate shows that the product meets the essential requirements according to the various procedures for CE certification and are thus safe and effective.
As soon as the United Kingdom leaves the European Union, the EU will consider it a "third country”. It has the same obligations as any other country outside of the European Union:
- Manufacturers of medical devices that are located in the United Kingdom must be represented by an authorized representative present on the territory of the 27 European member states (EU27).
- Manufacturers of medical devices who have an authorized representative in the United Kingdom must designate a new authorized representative within the EU27.
- CE certificates issued by a British-registered institution are no longer valid within the EU27 after Brexit. The affected manufacturers of medical devices must apply for a new CE certificate via a registered institution in one of the 27 European member states.
Manufacturers who have met these requirements can also sell their products within the European Union after Brexit. There will be no shortage of their products.
Brexit will have consequences for many medical devices. A medical device that was available in Belgium before Brexit, may not be after Brexit. You can find out if a product is affected by Brexit using the information on the package. A medical device is affected if one or more of the following conditions are met:
- the manufacturer is headquartered in the United Kingdom: this is usually shown by a factory symbol;
- the authorized representative is headquartered in the United Kingdom: this is usually shown by a box with EU REP;
- the CE mark is followed by a number with four digits, the following numbers are affected by Brexit: 0086, 0088, 0120, 0843.
Brexit does not affect medical devices that have been brought to market in the EU before Brexit.
The invalidation of CE certificates by Brexit and/or localization of the manufacturer or authorized representative outside of the EU27 is not linked to the safety and efficacy of the medical devices. The FAMHP will continue monitoring the safety of legally marketed medical devices and combating illegally marketed products.
If a medical device is no longer available, the FAMHP advises you to contact your doctor or pharmacist. They know your medical history and can propose a solution.
A manufacturer selling medical devices must meet strict criteria to guarantee their safety and quality. If that is the case, you may purchase their medical devices online. Please note: after Brexit you will pay import taxes on medical devices from manufacturers/distributors from the United Kingdom.