The Critical Medicines Act will change how EU public buyers tender for critical medicines. Resilience requirements become mandatory; where a medicine depends heavily on a few non-EU countries, EU-made product and active substance can earn preference; and five or more Member States can ask the European Commission to buy for them. This briefing covers what has been agreed, what is still pending, and what tender teams — and the distributors and suppliers bidding into those tenders — should be ready to document.

This article is an industry briefing for operational awareness. It is not legal or procurement advice. The final text, article numbering, and dates depend on formal adoption and publication in the Official Journal. Confirm requirements in each tender’s documents and with qualified counsel.

What the Critical Medicines Act is, and where it stands now

The Critical Medicines Act is an EU regulation, proposed by the Commission in March 2025, to strengthen security of supply of critical medicines such as antibiotics, insulin, and painkillers. For buyers, the practical part is public procurement: what contracting authorities must put into tenders, and how Member States can buy together.

Council and Parliament negotiators reached a provisional agreement on 12 May 2026. Member-state ambassadors (Coreper) endorsed the compromise text on 30 June; Parliament’s Public Health committee approved it on 14 July. Parliament’s plenary vote is indicatively scheduled for 23 November 2026; the Council must then formally adopt the text after legal-linguistic revision.

Timing has a second dependency. Under the agreed text, the regulation applies from the first Official Journal publication of the Union list of critical medicinal products under the new EU pharmaceutical legislation — itself still awaiting Parliament’s second reading. The procurement requirements then apply to tenders launched after that date.

Agreed vs still pending

Agreed (provisional): mandatory resilience requirements in tenders; conditional EU-manufacturing preference; Commission-run procurement for five or more Member States; safeguards on national contingency-stock requirements.

Still pending: the plenary vote, Council adoption, final wording and numbering, Official Journal publication, entry into force, and publication of the Union list that triggers application.

Resilience requirements become mandatory in critical-medicine tenders

For public procurement of critical medicines within the scope of the EU public procurement directive (Directive 2014/24/EU), the agreed text says contracting authorities shall apply “resilience requirements.” A tender for a listed critical medicine will need at least one resilience element, not price alone.

Where they can appear

Authorities must use at least one of four routes:

• selection criteria (who may bid);
• technical specifications (what must be offered);
• best price-quality award criteria (how bids are scored);
• contract performance clauses (what the winner must do).

What they may cover

The requirements must support diversification of supply sources of active substances and, where applicable, finished products, including within the EU, and reward reliable and compliant suppliers. They may also cover stockholding, timely delivery, and supply-chain management. Multi-winner approaches should be considered where appropriate.

Bidders will be asked to evidence these points. Building that diversification internally is a separate job; see our briefing on shortage-resilient pharmaceutical sourcing.

Documented exceptions

Authorities may exceptionally skip these requirements — for example where only one supplier can deliver, where a similar tender in the previous two years drew no suitable bids, or where costs would be disproportionate — but must document the justification in writing.

EU-made preference: when it applies and how it is scored

The “Buy European” element is narrower than headlines suggest.

Only where dependency has been identified

It applies only where an EU-level vulnerability evaluation, run through the Medicines Shortages Steering Group (MSSG), has found high dependency on a single or a limited number of non-EU countries. Then contracting authorities must favour EU manufacturing, in line with the Union’s international commitments. The preference lasts while the product stays listed and designated vulnerable, and for at least five years from that designation.

Reserved lots or proportional scoring

In the agreed compromise text (figures and numbering may change in the final text), authorities must use at least one of two mechanisms:

• in multi-winner tenders, reserve at least one lot of at least 50% of total volume for suppliers offering the medicine and its active substance manufactured in the EU; or
• score bids so the EU manufacturing share is rewarded proportionately, optionally with extra points for 50% or more EU-manufactured product and active substance.

What does not count, and what must be proven

For this purpose, “manufacturing in the Union” excludes import, repackaging, packaging other than immediate packaging, labelling, quality testing and, where applicable, certification. Relabelling, repacking, or release in the EU does not make a product EU-made — a point distributors should keep clear in any bid. Where the tender requires it, EU-manufacturing claims must be backed by documents the contracting authority can verify independently.

Collaborative procurement: the Commission buying for five or more Member States

Under the agreed text, when five or more Member States jointly request it, the Commission must launch a procurement on their behalf or in their name unless it gives substantiated reasons not to. This covers critical medicines with an identified supply-chain vulnerability or an MSSG recommendation for common procurement, plus certain medicines of common interest. The Commission can also invite a joint request.

Other Member States get four weeks to join; the Commission decides within 15 working days after that; participants must accept binding minimum quantities. Equivalent resilience requirements apply where relevant. A lighter route lets three or more Member States ask the Commission to facilitate a cross-border procurement for medicines of common interest.

For suppliers, that can mean fewer, larger, multi-country tenders for some products.

The Union list link, and a tender-prep checklist

The Act’s obligations attach to medicines on the Union list. A non-legislative version already exists: EMA’s Union list of critical medicines, version 2.1 (revision 1), last updated in January 2026, with the 2026 annual review expected in December 2026. Use it now as a screening proxy, not legal scope — the Act refers to the list as published in the Official Journal.

Evergreen tender-prep checklist

1. Screen your portfolio against the current Union list; re-screen after each update.
2. Track vulnerability designations — EU preference applies only to products designated vulnerable.
3. Map origin per SKU: finished-product site and active-substance site, with country.
4. Separate manufacturing steps from import, repacking, labelling, testing, and release.
5. Build an origin evidence pack an authority could verify independently.
6. Prepare supply commitments: lead times, stockholding you can actually hold, interruption notification.
7. Review tender or bid templates for all four routes.
8. Plan for multi-winner and reserved-lot structures.
9. Watch for Commission-run tenders and their minimum quantities.
10. Log milestones as review points — plenary vote, Council adoption, Official Journal publication, Commission guidelines and national programmes (due within a year of entry into force), and the Union list publication.

Documents buyers may request from distributors and suppliers

Depending on the tender, expect requests for:

• manufacturing country and site of the finished product and of the active substance;
• evidence for any EU-manufacturing claim;
• information showing diversified active-substance or product sources;
• delivery, stockholding, and interruption-notification commitments;
• standard pharmaceutical supplier qualification evidence for the supplying entity.

MedLogIl works with pharmacies, hospitals, and healthcare providers on global pharmaceutical and medical-product distribution, including sourcing and documentation support. If you are sourcing for a tender and need help gathering product documentation, you can request a quote.

Teams that keep origin records and supply commitments current can treat each legislative step as a routine review.

Sources

1. Council of the European Union — ST 11059/26 (30 June 2026), outcome of proceedings with the final compromise text endorsed by Coreper, interinstitutional file 2025/0102(COD). Agreed text, pending formal adoption; numbering provisional. Council document PDF.
2. European Parliament — “Deal on tackling EU shortages of essential medicines” (press release, 12 May 2026). Provisional agreement. EP press room.
3. European Parliament Legislative Observatory — procedure file 2025/0102(COD) (committee approval 14 July 2026; indicative plenary 23 November 2026). OEIL procedure file.
4. Council of the European Union — “Critical medicines act: Council and Parliament reach provisional deal” (press release, 12 May 2026, updated 30 June 2026). Consilium press release.
5. Council of the European Union — “New rules for critical medicines in the EU” (policy page). Consilium policy page.
6. European Commission — Critical Medicines Act. Commission CMA page.
7. European Medicines Agency — Union list of critical medicines (version 2.1, revision 1; vulnerability methodology). EMA Union list page.
8. European Medicines Agency — “Union list of critical medicines: 2026 annual review status” (presentation, 30 June 2026; final list expected December 2026). EMA presentation PDF.
9. European Parliament Legislative Observatory — procedure file 2023/0131(COD), EU pharmaceutical legislation (awaiting Parliament second reading). OEIL procedure file.