Change #4 of 10: Supply Chain / RA

EU medicine shortage prevention rules: notification periods and prevention plans

You'll have to tell regulators up to a year before you stop supplying.

Article 120 of the agreed Regulation requires notice at least 12 months before permanently ceasing supply and six months before a temporary suspension or expected disruption. Article 121 requires a shortage prevention plan for every prescription medicine. The agreed text provides for these rules to apply six months after entry into force, earlier than most of the package.

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Regulation Art. 120: Notifications

Notify regulators before you stop

Agreed text

Permanent cessation

12months

before the last supply, also for MA withdrawal requests

2 months today (Art. 23a)

Temporary disruption

6months

before a suspension, or a disruption expected to last over two weeks

2 months today (Art. 23a)

Shortage prevention plan for every prescription medicine, sent within two days of a request.

The agreed Regulation provides for these notification rules to apply six months after entry into force, earlier than most of the package. Exact dates follow publication.

The scale of the obligation

Supply management becomes a regulatory document

The prevention plan isn't an ops contingency plan. It's a regulatory document authorities can ask to see at two days' notice.

12mo

Minimum notice before the last supply when permanently ceasing marketing in a Member State, or requesting MA withdrawal

SourceRegulation Art. 120(1), agreed text

6mo

Minimum notice before a temporary suspension, or a supply disruption expected to last more than two weeks

SourceRegulation Art. 120(1), agreed text

2 days

To hand over the shortage prevention plan when a national authority, EMA or the Commission asks for it

SourceRegulation Art. 121(3), agreed text

What's actually changing

From short notice to long, harmonised notice

Under the current framework, notice is short and practice varies by Member State. The agreed Regulation replaces that with longer, harmonised obligations.

Change areaCurrent EU rulesAgreed text

Shortage prevention plan

Current EU rules

No formal plan required. Internal contingency plans are operational, not regulatory documents.

Agreed text

MAH establishes and keeps up to date a plan for every prescription medicine, following EMA guidance, and submits it within two days of a request (Art. 121).

Discontinuation notice

Current EU rules

At least two months before an interruption (Art. 23a of Directive 2001/83/EC), with varying national practice.

Agreed text

At least 12 months before the last supply for permanent cessation or an MA withdrawal request; at least six months for a temporary suspension (Art. 120).

Disruption reporting

Current EU rules

No harmonised EU timeline for expected disruptions. Different definitions and windows per Member State.

Agreed text

Expected disruptions of more than two weeks notified as soon as possible and at least six months ahead, electronically in EMA formats. Shorter notice only in substantiated exceptional circumstances.

Critical medicines

Current EU rules

A Union list of critical medicines exists, but MAH obligations attached to it are limited.

Agreed text

Before withdrawing a critical medicine or priority antimicrobial, the MAH must publicly offer to transfer the MA or grant a letter of access (Art. 120(4)). The Union list is set in law (Art. 137).

The agreed text is not yet published in the Official Journal. Application dates will be fixed by the published act.

How Regunaut helps

Know your notice deadlines before supply stops

Workbench answers notice-period and prevention plan questions against the agreed Regulation. Atlas shows which markets a supply change touches, and Alerts catches EMA guidance and Union list updates.

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☷ Quick Tasks / Notice owed after a CMO exit Sources

You09:14 AM

Our CMO is stopping API supply in 90 days. Once the new shortage rules apply, how much notice would we owe regulators, and what do we do if we can't meet it?

Regunaut09:14 AM

understanding your question…
Shortage prevention · current rules against the agreed text

Warning details⌄

Based on the agreed text, which is not yet in the Official Journal. Dates count from entry into force.

1. Short answer

An expected disruption of more than two weeks needs at least six months' notice under the agreed text, so 90 days is already short. Notify as soon as you become aware and substantiate why earlier notice was not possible.

2. What changes

AreaTodayAgreed text

Disruption noticeNo harmonised EU timelineAt least six months ahead, electronically in EMA formats [Art. 120(1)]

Permanent cessationTwo months before an interruptionAt least 12 months before the last supply [Art. 120(1)]

Prevention planInternal contingency plans onlyPlan per prescription medicine, handed over in two days [Art. 121(3)]

3. What to do now

Notify the disruption now and record why six months' notice was not possible.
Check whether the product is on the Union list of critical medicines.
Start a shortage prevention plan for each prescription product.

Citations (5)⌄

Example response · Condensed for this product demonstration

Ask a follow-up question...↑

1 / 424

Council of the
European UnionBrussels, 28 September 2026
(OR. en)

Interinstitutional File:
2023/0131(COD)7105/2/26 REV 2

LEGISLATIVE ACTS AND OTHER INSTRUMENTS

Subject:

Position of the Council at first reading with a view to the adoption of a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL laying down Union procedures for the authorisation and supervision of medicinal products for human use and establishing rules governing the European Medicines Agency
Adopted by the Council on 28 September 2026

Article 120

Marketing authorisation holder notifications

1. Without prejudice to the provisions on notification referred to in Article 25 of this Regulation and Article 206 of Directive (EU) 2026/…+, the holder of a national marketing authorisation for a medicinal product and the holder of a centralised marketing authorisation for a medicinal product (both referred to in this Chapter as ‘the marketing authorisation holder’) shall notify the competent authority of the Member State on whose market that medicinal product has been placed and, in addition, for a centrally authorised medicinal product, the Agency (both referred to in this Chapter as ‘the competent authority concerned’) of the following, and explain the reasons therefor:

(a) any decision to permanently cease the marketing of a medicinal product in that Member State no less than 12 months before the last supply of that medicinal product into the market of that Member State by the marketing authorisation holder;

(b) any request to withdraw the marketing authorisation for that medicinal product authorised in that Member State no less than 12 months before the last supply of that medicinal product into the market of that Member State by the marketing authorisation holder;

(c) any decision to temporarily suspend the marketing of a medicinal product in that Member State as soon as possible and no less than six months before the start of the temporary suspension of supply of that medicinal product into the market of that Member State by the marketing authorisation holder;

[Art. 120(1)](d) any temporary disruption in supply of a medicinal product in that Member State of an expected duration of more than two weeks based on the demand forecast of the marketing authorisation holder, as soon as possible and in any event no less than six months before the start of such temporary disruption of supply. By way of derogation from point (d) of the first subparagraph, marketing authorisation holders shall notify the temporary disruption in supply of a medicinal product in that Member State as soon as they become aware of such temporary disruption where exceptional circumstances directly related to the supply disruption, which shall be duly identified and substantiated to the competent authority concerned, prevented the marketing authorisation holders from complying with the deadline specified therein. The marketing authorisation holder shall make the notification electronically and in the formats made available by the Agency. The Agency shall consult the Member States when drawing up the formats.

2. For the purposes of the notifications made in accordance with paragraph 1, first subparagraph, points (a), (b) and (c), the marketing authorisation holder shall provide the information set out in Part I of Annex IV. For the purposes of the notifications made in accordance with paragraph 1, first subparagraph, point (d), the marketing authorisation holder shall provide the information set out in Part III of Annex IV. The marketing authorisation holder shall immediately notify the competent authority concerned, as appropriate, of any relevant changes to the information provided in accordance with this paragraph.

Workbench

Answers notice-period questions against the agreed Regulation, and reads your existing continuity plans to say what a shortage prevention plan would still need, with every point cited.

See Workbench

Atlas

Keeps every product's registrations by market, so you know which Member States a cessation or disruption touches. Notice deadlines sit on the timeline as tasks with an owner and status.

See Atlas

Alerts

Watches EMA and national authorities for shortage guidance, prevention plan guidance and updates to the Union list of critical medicines, and matches each one to the products it affects.

See Alerts

A 30-minute live walkthrough of Atlas, Alerts and Workbench, on your own products and markets

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Where things stand

The shortage crisis gave regulators the mandate to act

COVID-19 exposed EU medicine supply vulnerabilities. The agreed Regulation turns that into hard notice periods.

~75%

Of all medicinal products authorised in the EU are covered by the second version (2024) of the Union list of critical medicines

European Medicines Agency

6mo

After entry into force, the notification and prevention plan rules apply, well before most of the package

Regulation Art. 187, agreed text

2mo

Current minimum notice before interrupting supply, which the new periods replace

Art. 23a, Directive 2001/83/EC

Common questions

What teams are asking about shortage prevention

Which products require a shortage prevention plan?

Every medicinal product subject to medical prescription, plus products identified under Art. 132(4) of the agreed Regulation. EMA will issue guidance on content, scaled to risk. Critical medicines carry further obligations.

When does the 12-month clock start?

It runs back from the last supply into that Member State: you must notify no less than 12 months before it. In practice a cessation decision has to reach regulatory affairs well over a year ahead, so internal processes must flag it immediately.

What does a disruption notification require?

The information listed in Annex IV of the agreed Regulation, submitted electronically in EMA's formats, at least six months before an expected disruption of more than two weeks. Where exceptional circumstances prevent that, you notify as soon as you become aware and substantiate why.

Is our existing supply continuity plan sufficient?

Almost certainly not in its current form. Internal plans are operational documents. They need restructuring into the content EMA's guidance will set, ready to hand over within two days of a request.

What are critical medicines?

Medicines on the Union list of critical medicinal products, whose shortage would seriously harm patients. Under the agreed Regulation, MAHs of listed products have additional obligations, and before withdrawing one they must publicly offer to transfer the MA or grant a letter of access.

Notice periods only work when someone owns them, which is the point of turning regulatory requirements into product action plans.
Changes to critical medicine lists and EMA guidance reach your team through regulatory change monitoring with Alerts.
The shortage provisions sit in the companion EU pharmaceutical Regulation.
Shortage prevention is one of ten changes covered in our guide to the new EU pharmaceutical directive.
Dates that depend on publication are tracked on the EU pharma package legislative timeline.

Sources

Article numbers refer to the Council's position at first reading of 28 September 2026 (ST 7106/2/26 REV 2 for the directive, ST 7105/2/26 REV 2 for the regulation), which reflects the political agreement of December 2025. Numbering may change in the act published in the Official Journal.

Know your notice deadlines before a supply event starts the clock

A cessation decision has to reach regulatory affairs more than a year before the last supply. Start with the prescription products that need a prevention plan and any on the Union list of critical medicines.

Book a shortage prevention walkthrough

30 minutes on your own portfolio: which products need a prevention plan, and how Workbench, Atlas and Alerts keep track of the notice periods.

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Ask Workbench yourself

Put your shortage and notice-period questions to Workbench and get answers that cite the agreed text and EMA guidance.

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Where to expand next

Loss-of-exclusivity planning

EU medicine shortage prevention rules: notification periods and prevention plans

Notify regulators before you stop

Supply management becomes a regulatory document

From short notice to long, harmonised notice

Shortage prevention plan

Discontinuation notice

Disruption reporting

Critical medicines

Know your notice deadlines before supply stops

1. Short answer

2. What changes

3. What to do now

Workbench

Atlas

Alerts

The shortage crisis gave regulators the mandate to act

What teams are asking about shortage prevention

Related reading

Sources

Know your notice deadlines before a supply event starts the clock

Book a shortage prevention walkthrough

Ask Workbench yourself