How Drug Shortages Are Reported in Germany

In Germany, drug shortages are reported by the marketing authorisation holder to the competent federal authority, BfArM for most medicines and the Paul-Ehrlich-Institut for vaccines, sera and blood products, under section 52b of the Medicinal Products Act (AMG). A shortage is reportable when normal supply is expected to be interrupted for more than two weeks, or when demand rises to a level that cannot be adequately met. The report is a notification, not an application, and it does not by itself change what a pharmacy is allowed to dispense.

What follows is the process end to end: who is obliged to report, to whom, on what trigger, what the authority does with the report, how the advisory committee works, when the Federal Ministry of Health formally declares a supply deficiency, and what that declaration actually permits at the counter and in the hospital pharmacy.

Who has to report, and to whom

The obligation is anchored in section 52b AMG, which begins from a broader duty: pharmaceutical companies and wholesalers that place a medicine on the German market must ensure appropriate and continuous supply so that patient need in Germany is covered. Reporting is the instrument that makes failures of that duty visible.

Responsibility splits by product class, and the split is administrative rather than clinical.

That split has a practical consequence people discover late. If you go looking for the reporting history of a blood product in the BfArM database, you are searching the wrong register.

"You can look at it through the BfArM history, but blood products are simply not in there." (Market access lead, pharmaceutical manufacturer of blood products; translated from German)

Beyond the authorisation holder, the duty chain extends further than most summaries suggest. Under section 52b paragraph 3a AMG, pharmaceutical companies must inform hospitals immediately about shortages of prescription medicines used in inpatient care that have come to their attention. And under paragraph 3e, on request from BfArM, companies, manufacturers and wholesalers must submit data on stock, production including the manufacturing site of the active substances actually used, and sales volumes, while hospital pharmacies and hospital-supplying pharmacies must report available stock.

The trigger: when does a supply interruption become reportable

BfArM defines a Lieferengpass as an interruption of delivery in the usual volume expected to last longer than two weeks, or a markedly increased demand that cannot be adequately met. Two features of that definition are worth pausing on.

First, it is prospective. The trigger is the expectation of a two-week interruption, not the completion of one. A company that waits until two weeks have elapsed has reported late.

Second, it includes demand-side events. A product can be in normal production and still be in shortage if demand has risen beyond what the supply chain can absorb. Several of the most disruptive German shortages of recent years were of this type rather than of the factory-failure type, and the distinction matters when you try to estimate how long a shortage will run.

A report is expected to identify the product at pack level, state when the interruption begins, estimate when supply will resume, give a reason, and indicate whether alternatives are available. The estimated end date is revised as the situation develops, and revisions are normal rather than exceptional.

What BfArM does with a report

The authority does not simply file the notification. The first assessment is a triage question: is this a supply-relevant medicine? BfArM examines in particular whether alternative preparations are available for the therapy and whether those alternatives are actually on the market.

This is where the pivotal distinction in the whole system sits. BfArM states it directly: a Lieferengpass does not have to be a Versorgungsengpass, because alternative medicines are often available and patient care continues. A notification is an early signal about one product, not a statement that patients are going without.

The steps that follow depend on that assessment.

1. Publication. The notification is published in the shortage database, including any information on possible alternative preparations.
2. Classification. BfArM maintains a list of supply-relevant and supply-critical active substances, drawn up after consulting the advisory committee and published on its website. A shortage touching that list is treated differently from one that does not.
3. Data collection. Where needed, the authority requests stock, production and sales data from companies, wholesalers and hospital pharmacies.
4. Measures. After consulting the advisory committee, the competent federal authority may take suitable measures to avert or mitigate a supply-relevant shortage. Section 52b explicitly includes ordering allocation of medicines and, for supply-critical active substances, ordering stockholding.

The Beirat: who sits on it and what it decides

The Beirat is a standing advisory committee at BfArM that continuously observes and assesses the medicines supply situation, and it must be consulted before the authority classifies substances as supply-critical or orders measures. Its composition is set out in section 52b paragraph 3b AMG and is deliberately broad.

It includes a representative of patient interests alongside the medical learned societies, the professional bodies of pharmacists, the drug commissions of the health professions chambers, the leading associations representing the economic interests of pharmaceutical companies, the association of full-line wholesalers, the National Association of Statutory Health Insurance Funds, the National Association of Statutory Health Insurance Physicians, the German Hospital Federation, and the competent federal and state authorities. The Federal Ministry names the participating associations, and BfArM publishes the list.

Two details are easy to miss and shape how the committee behaves. Members are personally bound to confidentiality regarding the facts and information they learn in the committee, which is why deliberations are not public. And the committee's rules of procedure must provide for documenting the supporting reasons of both majority and minority votes, which is an unusual transparency requirement for a body that otherwise works behind closed doors.

The BfArM pages on the Beirat carry the current membership and meeting information.

How a Versorgungsmangel is formally declared

A Versorgungsmangel, a formally declared supply deficiency, is not declared by BfArM. It is declared by the Federal Ministry of Health under section 79 paragraph 5 AMG, on the basis of BfArM findings and with the involvement of the state authorities, and it is published as an announcement in the Bundesanzeiger.

The legal threshold is high, and the wording is specific. It applies where there is a supply deficiency affecting medicines needed to prevent or treat life-threatening illnesses, or where a serious communicable disease is spreading in a way that requires an immediate provision of specific medicines far beyond the usual scale. BfArM describes the instrument as an exceptional authorisation for supply-critical situations, to be applied under very strict criteria and always involving a risk-based assessment.

What the declaration does is delegate flexibility downwards. It permits the competent state authorities to allow, case by case and for a limited period, that medicines not authorised or registered in Germany are placed on the market and brought into the country. The condition is that the medicine may lawfully be marketed in the state it comes from, or that the competent federal authority has established that its quality is assured and that its use can be expected to have a positive benefit-risk balance.

The time limit is real. Permissions are granted to the authorisation holder for a defined period, and once it expires the holder may no longer place medicines on the market on the basis of the exemption. This is the mechanism that lets Germany bring in foreign-labelled stock during a severe shortage without dismantling the authorisation system.

From notification to the pharmacy shelf

The chain from a company report to a patient receiving something is longer than the legal text suggests, and each link involves different people.

Step seven is where the burden lands, and it lands on people who had no part in steps one to six.

What pharmacies and hospitals may do when a product is unavailable

Three routes are available in practice, in roughly this order of preference.

1. Substitution within German supply. Another pack size or strength, or an equivalent from a different authorisation holder. German dispensing rules were loosened during the shortage waves of recent years to give pharmacies more room to substitute without a fresh prescription, and the ALBVVG carried several of those flexibilities forward.
2. Therapeutic alternative. A different substance in the same class, which is a clinical decision requiring the prescriber, and which is why it sits below simple substitution rather than above it.
3. Single-patient import. Under section 73 paragraph 3 AMG, pharmacies may bring in a finished medicine that is not authorised in Germany, in small quantities, against an existing order for an individual patient, if it may lawfully be marketed in the state it comes from and if no medicine identical in active substance and comparable in strength is available in Germany for that indication. Hospital pharmacies and hospital-supplying pharmacies may hold appropriate quantities in advance for temporary stock, within what is necessary for proper patient care.

BfArM is candid about how this feels in practice. It describes the single-import route as a bureaucratically complex procedure that normally means several days of lead time before an individual prescription can be filled, and it names the flexibility unlocked by a section 79 paragraph 5 announcement as the remedy for exactly that friction.

Where the process leaves gaps for the people running it

Three gaps are structural rather than fixable by better notification discipline.

• The register tells you about the product, not about your supply. A notification says a company has a problem. Whether you can order the product today is a wholesaler question, answered somewhere else entirely.
• Alternative notes are indicative. The database flags that alternatives exist. It does not tell you which of them your wholesaler has in stock, at which pack size, at which price.
• The process stops at the border. Everything above is national. The moment the answer is "this is available in another market", you are outside the German system and need product data from that market.

That last gap is the one professionals feel most often, because it appears at precisely the moment the shortage has become serious. Consolidating BfArM notifications with product data from 50+ countries in one place is what pharmazie.com does, and it is the reason the platform tends to be used by hospital pharmacies and importers rather than by anyone reading a shortage list casually.

The reporting system itself works reasonably well at what it was designed to do: make failures of supply visible early, and give the state a graduated set of responses. What it was never designed to do is answer the question the pharmacist is actually holding, which is what to dispense to the patient in front of them this afternoon.

This content is intended for healthcare professionals and does not constitute medical advice. Last reviewed: July 2026.