Comparison of national measures to protect the supply of medicines and medical devices

Is there a list of critical or other medicines subject to supply restrictions?

A distribution restrictions list (Vertriebseinschränkungen) is maintained by the Austrian Federal Office for Safety in Health Care (BASG) of medicines which may not be exported from Austria, or may only be exported to a limited extent, in order to ensure the supply for patients in Austria. MAHs and wholesalers must report supply bottlenecks so that the BASG can publish the restriction and, if necessary, impose an export ban.

There is also a list on ensuring the supply of medicinal products (Liste über die Sicherstellung der Arzneimittelversorgung), which lists products considered to be particularly relevant to public health and are therefore subject to a continuous supply and stockpiling obligation, eg stockpiling for several months. MAHs must report stock levels on a regular and ad hoc basis and must take immediate action in the event of shortages to ensure that the needs of patients in Austria are met.

Manufacturer obligations in the event of a supply shortage

Any medicine: In line with EU law, although with tighter timelines, MAHs must immediately notify the BASG via the 'Zulassung und Lifecycle ASP' eService if a prescription medicine is expected to be unavailable for more than two weeks or only partially available for more than four weeks.

Listed medicines: See above.

Medical devices: Reporting pursuant to Article 10a MDR or IVDR on this form. Manufacturers must also directly inform supplied operators, institutions, and professionals of any device interruption or discontinuation, also stating the reasons, at least six months in advance.

Manufacturer obligations if withdrawing a product

Any medicine: With the exception of human medicines for export, a marketing authorisation holder must notify the BASG of the intended, temporary or permanent, withdrawal of a medicine from the market at least four months in advance, stating the reasons, after which the BASG publishes the information in its register. The notification must be submitted via eService and will be published by the BASG.

Listed medicines: None. 

Medical devices: The manufacturer must inform the affected economic operators, healthcare institutions and healthcare professionals of the impending discontinuation, providing the reasons, and this information must be communicated at least six months in advance.

Is there a list of critical or other medicines subject to supply restrictions?

There is a critical medicines list (MITM) established by the French drug agency (ANSM).

In comparison to other European lists, the French MITM list is broader and more detailed, tailored specifically to the French healthcare context and population needs. 

Manufacturer obligations in the event of a supply shortage

For any medicines: Pharmaceutical companies must maintain safety stocks. Manufacturers must immediately notify the ANSM if a shortage or supply disruption is anticipated. 

For listed medicines: Manufacturers  are required to develop shortage management plans (PGP – Plans de gestion des pénuries) for the medicines of major therapeutic interest (MITM – Médicaments d’intérêt thérapeutique majeure) which specify the solutions to be implemented as quickly as possible to ensure the continuity of treatment for the patients concerned.

For any medical device: Manufacturers must notify the ANSM of potential supply interruptions, ensure transparency on availability, cooperate in managing risks, and participate in shared information systems designed to co-ordinate stakeholders and mitigate shortage impacts.

Manufacturer obligations if withdrawing a product

For any medicine: Manufacturers must notify the ANSM well in advance of any withdrawal and inform healthcare professionals and patients.

For listed medicines: Critical medicines are subject to stricter regulatory obligations than other medicines, including:

• Longer notice periods before withdrawal: Manufacturers must notify the ANSM at least one year before the planned withdrawal from the market of a MITM.
• Facilitation of replacement or alternatives: Manufacturers must facilitate the identification and importation of equivalent or alternative medicines, including from other countries or generics, to guarantee continuity of care.

For any medical device: Manufacturers must notify the French drug agency ahead of withdrawal and cooperate to minimise impacts, including assisting in identifying alternatives and ensuring continuity of patient care.

Is there a list of critical or other medicines subject to supply restrictions?

In Germany, the Federal Institute for Drugs and Medical Devices (BfArM) publishes a list of supply-critical active substances. 

BfArM provides a publicly available list from information voluntarily submitted by manufacturers containing active substances listed as supply-critical, as well as medicinal products with prescription-only active substances that either have a market share of 25% or more or are subject to a legal obligation to report.

BfArM also publishes a list of medicinal products relevant for pediatric care with potentially constrained supplies. 

Manufacturer obligations in the event of a supply shortage

Medicinal products: Manufacturers and distributors  must immediately inform hospitals of supply shortages of prescription medicines for inpatient care. They must provide BfArM electronically with data on available stocks, production, sales volumes, and information on impending supply shortages of the respective medicinal product.

Medical devices: EU MDR and IVDR Article 10a.

Manufacturer obligations if withdrawing a product

Medicinal products: No specific statutory obligations.

Medical devices: EU MDR and IVDR Article 10a.

Is there a list of critical or other medicines subject to supply restrictions?

The Dutch National Coordination Centre for Medicines (Landelijk Coördinatiecentrum Geneesmiddelen or LCG) lists of critical medicines are updated biannually. There are four lists: medicines for adults (a patient and a healthcare professional edition), and the list for children’s medicines in both editions. 

Manufacturer obligations in the event of a supply shortage

Medicinal products: All medicines are treated the same, but the criticality of a medicine will be taken into account when preparing a response.

Manufacturer notifications required to be sent to the Medicine Shortages and Defects Notification Centre in the event of:

• Supply shortage.  Must be notified without delay, but in any event two months prior to the interruption
• When part or all of the ordered medicines cannot be supplied by the MA holder for a period of at least 14 days. It is irrelevant whether or not there are alternative suppliers.

Notification could result in: 

• MEB or the Health and Youth Care Inspectorate (the Inspectorate) imposing further obligations on the manufacturer, or even its competitors (ii) the Dutch Government imposing a compulsory patent licence (dwanglicentie) in the public interest (though this is a highly rare event) (iii) under future law, a stockpiling obligation to address shortages. Read our insight Politics of supply shortages of medicines and medical devices in Europe.

Medical devices: Notification pursuant to EU MDR or IVDR Article 10a: Medical Devices Supply Shortage Centre or the Netherlands Healthcare Import Centre. 

If a medical device cannot be supplied for longer than 14 days, the notification is published in a publicly accessible register on the website of the Dutch Zorg Inkoop Netwerk Nederland.

Manufacturer obligations if withdrawing a product

Medicinal products: Manufacturer to submit as soon as possible, and at least two months in advance, a notification to the Medicine Shortages and Defects Notification Centre, similar to the procedure in the preceding column in case of supply shortage. 

The MEB and the Inspectorate will assess the notification in the same manner as the notification of (suspected) supply shortage. The MEB and the Inspectorate will analyse the notification and decide on the solution for the relevant market and patients. In case the medicine is included in the critical medicine list, the MEB and the Inspectorate will consider this when deciding on the best solution.

Other manufacturer obligations are to keep certain documentation available for the time periods specified in the Dutch Medicines Act, and to deregister from the Dutch Chamber of Commerce in case the manufacturer and/or its European Authorised Representative cease to exist. 

Medical devices: Withdrawals from the market of medical devices registered at NOTIS (the national Dutch registry for medical devices) must be notified pursuant to the EU MDR and IVDR Article 10a. National registration might be required in case of specific categories of medical devices, e.g. tailor-made medical devices under Article 2 of the Dutch Medical Devices Regulations.

Manufacturers are also obliged to keep certain documentation available for time periods specified in the Dutch Medical Devices Act, and to deregister from the Dutch Chamber of Commerce in case the manufacturer and/or its European Authorised Representative cease to exist. 

Is there a list of critical or other medicines subject to supply restrictions?

Critical Medicines List maintained by the Ministry of Health. 

List of products (medicinal products, foodstuffs for special nutritional purposes and medical devices) at risk of unavailability. 

Manufacturer obligations in the event of a supply shortage

Medicinal products: Manufacturers must notify the Polish authority (President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products) of the temporary or permanent suspension of marketing of a medicinal product at least two months in advance or immediately for exceptional circumstances. 

Medical devices: EU MDR and IVDR Article 10a.

Manufacturer obligations if withdrawing a product

Medicinal products: See above. 

Medical devices: Polish manufacturers who have notified their placing of the product on the market are obliged to immediately notify the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of the fact that they have ceased to place the product on the market.

Is there a list of critical or other medicines subject to supply restrictions?

There is no publicly available national list of critical medicines in the UK.

However, various regional trusts of the National Health Service have their own critical medicines lists. 

Manufacturer obligations in the event of a supply shortage

Medicinal products: Manufacturers and distributors (excluding for parallel imports) must record and share information with the Department of Health and Social Care (DHSC) about any likely supply shortage or intention to discontinue any medicine (in any or all UK nations) that will have a direct impact on any patient who takes or may need to take the medicine. 

Manufactures must notify the DHSC of shortages, discontinuations or updates on current medicine supply issues via its website at least six months in advance, or if the information is not available six months in advance, as soon as reasonably practicable. The DHSC may request additional information.

Medical devices: 

• Great Britain (England, Scotland and Wales) has no obligation.
• In Northern Ireland, Article 10a of EU MDR and IVDR applies. 

Manufacturer obligations if withdrawing a product

Medicinal products: See above.

Medical devices: See above.