Dossier · Ordinary legislative procedure

Laying a framework for strengthening the availability and security of supply of critical medicinal products as well as the availability of, and accessibility of, medicinal products of common interest, and amending Regulation (EU) 2024/795

Reference: 2025/0102(COD) Ordinary legislative procedure
Where it stands: Parliament’s committee approved the deal reached with the Council on 14 July 2026; the plenary vote on it is still to come.
Stage: First reading
Lead committee: Public Health SANT

More facts (6)

Rapporteur: Tomislav SOKOL
Shadow rapporteurs: 7 members
Decisions in plenary: 1
Last vote: 20 Jan 2026 · Passed
Versions: 3 versions
Opinions from: ENVI, IMCO, ITRE

Rapporteur: Tomislav SOKOL
Shadow rapporteurs: 7 members
Decisions in plenary: 1
Last vote: 20 Jan 2026 · Passed
Versions: 3 versions
Opinions from: ENVI, IMCO, ITRE

Cite this page

Legislative Observatory

Link to this page

Where it stands

The steps of this kind of dossier and how far it has come, from the procedure file.

Referred to committee (done) 21 May 2025
Committee work (done) Report adopted 15 December 2025
Tabled for plenary (done) 19 December 2025
Plenary vote (done) Adopted 20 January 2026
Negotiations with the Council (current step) Deal approved in committee 14 July 2026
Published as law (to come)

A proposed EU law. Parliament and the Council must agree on the same text: Parliament adopts its position, then negotiates with the Council.

People

Committees and members responsible for the dossier, as the procedure file names them. Groups as recorded there.

Lead committee: Public Health SANT
Rapporteur: Tomislav SOKOL (EPP)
Shadow rapporteurs: Tiemo WÖLKEN (S&D), Ondřej KNOTEK (Patriots), Aurelijus VERYGA (ECR), Vlad VASILE-VOICULESCU (Renew), Tilly METZ (Greens), Catarina MARTINS (The Left), Christine ANDERSON (ESN)
Opinion: ENVI: Environment, Climate and Food Safety · rapporteur Michele PICARO (ECR)
Opinion: IMCO: Internal Market and Consumer Protection · rapporteur Marion WALSMANN (EPP)
Opinion: ITRE: Industry, Research and Energy · rapporteur Oliver SCHENK (EPP)

Decisions in plenary, 1

Every decision Parliament took on this dossier, newest first.

**Effect**: what the decision did. **Final vote**: for–against–abstained, and how it was recorded.
Date	Decision	Kind	Effect	Final vote
20 Jan 2026	Framework for strengthening the availability and security of supply of critical medicinal products as well as the availability of, and accessibility of, medicinal products of common interest	New laws	Passed	503 for, 57 against, 108 abstained by roll call

Voting grid

Export

Every roll-call vote on the dossier, in date and voting order, with each group's line at the date of the vote.

Each group's clear line at the date of the vote: a position with at least two thirds of the group's votes (at least 10 members voting), otherwise Divided; “< 10 voted” when fewer took part. Result: outcome, for–against–abstained (method).

Voting grid of 2025/0102(COD): one row per roll call, one column per group, then the result.
Vote	The Left	Greens	S&D	Renew	EPP	ECR	Patriots	ESN	Result
20 Jan 2026 Proposal to reject the text	Against	Against	Against	Against	Against	Against	Against	For	Rejected44–600–13
20 Jan 2026 Amendment 158	For	For	For	For	For	For	Against	Against	Adopted492–159–14
20 Jan 2026 Amendment 159	For	For	For	For	For	For	Against	Against	Adopted517–127–15
20 Jan 2026 Amendment 162	For	For	For	For	For	For	Against	Against	Adopted494–152–17
20 Jan 2026 Amendment 163	For	For	For	For	For	For	Against	Against	Adopted528–123–10
20 Jan 2026 Amendment 164	Against	For	Divided	For	For	For	Against	Against	Adopted450–205–8
20 Jan 2026 Amendment 257 to Article 3, paragraph 1, point 5	For	For	For	For	Against	Against	Divided	Against	Adopted325–284–33
20 Jan 2026 Amendment 250 to Article 16, after paragraph 2	For	For	Against	Against	Against	Against	Against	Against	Rejected141–516–7
20 Jan 2026 Amendment 170 to Article 21	For	For	For	For	For	For	Against	Against	Adopted525–123–14
20 Jan 2026 Amendment 178 to Article 22	For	For	For	For	For	For	Against	Against	Adopted529–120–16
20 Jan 2026 Amendment 187 to Article 23	For	For	For	For	For	For	Against	Against	Adopted527–121–15
20 Jan 2026 Amendment 244, adding text after recital 3	For	For	Divided	For	Against	Against	Divided	Against	Rejected227–299–138
20 Jan 2026 Amendment 259 to recital 4	Against	Against	Against	Against	Against	For	For	For	Rejected197–454–7
20 Jan 2026 Amendment 256, adding text after recital 12	For	For	For	For	Against	Against	Divided	Against	Adopted362–259–34
20 Jan 2026 Amendment 247, adding text after recital 22	For	For	For	Against	Against	Against	Against	Against	Rejected224–424–20
20 Jan 2026 Final vote	For	For	For	For	For	Abst.	Divided	Against	Adopted503–57–108

20 Jan 2026 Proposal to reject the text

Rejected 44–600–13

The Left

Against
Greens

Against
S&D

Against
Renew

Against
EPP

Against
ECR

Against
Patriots

Against
ESN

For
20 Jan 2026 Amendment 158

Adopted 492–159–14

The Left

For
Greens

For
S&D

For
Renew

For
EPP

For
ECR

For
Patriots

Against
ESN

Against
20 Jan 2026 Amendment 159

Adopted 517–127–15

The Left

For
Greens

For
S&D

For
Renew

For
EPP

For
ECR

For
Patriots

Against
ESN

Against
20 Jan 2026 Amendment 162

Adopted 494–152–17

The Left

For
Greens

For
S&D

For
Renew

For
EPP

For
ECR

For
Patriots

Against
ESN

Against
20 Jan 2026 Amendment 163

Adopted 528–123–10

The Left

For
Greens

For
S&D

For
Renew

For
EPP

For
ECR

For
Patriots

Against
ESN

Against
20 Jan 2026 Amendment 164

Adopted 450–205–8

The Left

Against
Greens

For
S&D

Divided
Renew

For
EPP

For
ECR

For
Patriots

Against
ESN

Against
20 Jan 2026 Amendment 257 to Article 3, paragraph 1, point 5

Adopted 325–284–33

The Left

For
Greens

For
S&D

For
Renew

For
EPP

Against
ECR

Against
Patriots

Divided
ESN

Against
20 Jan 2026 Amendment 250 to Article 16, after paragraph 2

Rejected 141–516–7

The Left

For
Greens

For
S&D

Against
Renew

Against
EPP

Against
ECR

Against
Patriots

Against
ESN

Against
20 Jan 2026 Amendment 170 to Article 21

Adopted 525–123–14

The Left

For
Greens

For
S&D

For
Renew

For
EPP

For
ECR

For
Patriots

Against
ESN

Against
20 Jan 2026 Amendment 178 to Article 22

Adopted 529–120–16

The Left

For
Greens

For
S&D

For
Renew

For
EPP

For
ECR

For
Patriots

Against
ESN

Against
20 Jan 2026 Amendment 187 to Article 23

Adopted 527–121–15

The Left

For
Greens

For
S&D

For
Renew

For
EPP

For
ECR

For
Patriots

Against
ESN

Against
20 Jan 2026 Amendment 244, adding text after recital 3

Rejected 227–299–138

The Left

For
Greens

For
S&D

Divided
Renew

For
EPP

Against
ECR

Against
Patriots

Divided
ESN

Against
20 Jan 2026 Amendment 259 to recital 4

Rejected 197–454–7

The Left

Against
Greens

Against
S&D

Against
Renew

Against
EPP

Against
ECR

For
Patriots

For
ESN

For
20 Jan 2026 Amendment 256, adding text after recital 12

Adopted 362–259–34

The Left

For
Greens

For
S&D

For
Renew

For
EPP

Against
ECR

Against
Patriots

Divided
ESN

Against
20 Jan 2026 Amendment 247, adding text after recital 22

Rejected 224–424–20

The Left

For
Greens

For
S&D

For
Renew

Against
EPP

Against
ECR

Against
Patriots

Against
ESN

Against
20 Jan 2026 Final vote

Adopted 503–57–108

The Left

For
Greens

For
S&D

For
Renew

For
EPP

For
ECR

Abst.
Patriots

Divided
ESN

Against

Add members’ columns

Versions, 3

The text of the dossier, version by version, newest first. Compare shows what changed between two consecutive versions.

Adopted by Parliament20 Jan 2026

Adopted text TA10-0001/2026 TA-10-2026-0001

Compare with tabled for plenary
Tabled for plenary19 Dec 2025

Report A10-0272/2025 A-10-2025-0272

Compare with committee draft
Committee draft18 Jul 2025

Draft report (SANT) SANT-PR-775742

Each version in short Written by AI from the official text — check the source

Adopted text TA10-0001/2026: Parliament's amended version of the proposed regulation lays down a framework to strengthen the security of supply and availability of critical medicinal products and improve access to medicinal products of common interest.
Report A10-0272/2025: Parliament's amended version of the proposed regulation aims to strengthen the security of supply and availability of critical medicinal products and improve access to medicinal products of common interest in the EU.
Draft report (SANT): The draft report proposes amendments to the Commission's regulation on critical medicinal products, aiming to strengthen supply security and availability, and to improve access to medicinal products of common interest.

Report a problem

Committee opinions: Draft opinion (ITRE), Draft opinion (ENVI), Opinion (ITRE), Draft opinion (IMCO), Opinion (IMCO), Opinion (ENVI)

What changed, 1

Between consecutive versions, newest pair first. The overviews are written by AI from the two texts; the comparison shows every change.

Latest Tabled for plenary → Adopted by Parliament Report A10-0272/2025 → Adopted text TA10-0001/2026

AI: What changed Written by AI from the official text — check the source

Adds provisions on contraceptives and abortifacients, defining them as medicinal products of common interest and requiring Member States to ensure their supply. Extends strategic project criteria to include reserving manufacturing capacity and adds requirements for financial support to ensure availability and affordability. Defines 'systemic wholesaler' and adds conditions for determining significant Union manufacture, including thresholds for active substance production. Lowers the threshold for joint procurement requests from five Member States and adds health security aspects to strategic partnerships. The other changes are formal or wording: typo fixes, terminology alignment, and removal of the report's justification section.

Read the changes · Report a problem

Compare the two versions

Timeline, 16

Every recorded step, newest first, grouped by stage; the latest stage is open.

Negotiations with the Council 5 steps · 20 Jan 2026–14 Jul 2026

14 July 2026

Committee approved the deal reached with the Council

The provisional agreement from the trilogues goes to the whole Parliament for a vote.
11 May 2026

Trilogue meeting

Negotiation between Parliament, Council and Commission on a common text.
16 March 2026

Trilogue meeting

Negotiation between Parliament, Council and Commission on a common text.
2 February 2026

Trilogue meeting

Negotiation between Parliament, Council and Commission on a common text.
20 January 2026

Parliament opened negotiations with the Council

After its vote Parliament sent the file back to committee, so that its negotiators can seek a compromise text with the Council (in “trilogues”).

Plenary stage 4 steps · 19 Dec 2025–20 Jan 2026

20 January 2026

Plenary vote

Sitting of 20 Jan 2026 Adopted text TA10-0001/2026 Report A10-0272/2025
19 January 2026

Debated in plenary

MEPs debated the text in the chamber ahead of the vote.

Sitting of 19 Jan 2026 Council / Commission text C10-0048/2025Report A10-0272/2025
13 January – 19 January 2026

260 amendments tabled for the plenary vote

Groups propose changes to the tabled text; each is voted on before the final vote.

Amendments 1–242 Amendments 243–252 Amendments 253–255 Amendments 256–257 Amendment 258 Amendments 259–260
19 December 2025

Report tabled for plenary

This is the text all MEPs vote on. Political groups can still table amendments to it.

Report A10-0272/2025

Committee stage 7 steps · 21 May 2025–15 Dec 2025

15 December 2025

Committee vote: report adopted

SANT (Public Health) voted on the amendments and adopted the report that goes to plenary.
11 November 2025

ITRE (Industry, Research and Energy) adopted its opinion

The opinion is attached to the report for the lead committee to consider.

Opinion (ITRE)
11 November 2025

IMCO (Internal Market and Consumer Protection) adopted its opinion

The opinion is attached to the report for the lead committee to consider.

Opinion (IMCO)
4 November 2025

ENVI (Environment, Climate and Food Safety) adopted its opinion

The opinion is attached to the report for the lead committee to consider.

Opinion (ENVI)
26 September – 13 October 2025

Amendments tabled in committee (3 batches)

Members of SANT (Public Health) proposed changes to the draft.

Amendments in committee (SANT)Amendments in committee (SANT)Amendments in committee (SANT)
18 July 2025

Draft report published

The rapporteur’s first text in SANT (Public Health). Members can table amendments before the committee votes.

Draft report (SANT)
21 May 2025

Referred to the SANT (Public Health) committee

The lead committee prepares the report; ENVI (Environment, Climate and Food Safety), IMCO (Internal Market and Consumer Protection), ITRE (Industry, Research and Energy) give an opinion.

Connections

Texts, decisions, people and other dossiers related to this one.

Texts voted on

Text REPORT on the proposal for a regulation of the European Parliament and of the Council laying a framework for strengthening the availability and security of supply of critical medicinal products as well as the availability of, and accessibility of, medicinal products of common interest, and amending Regulation (EU) 2024/795 Report A10-0272/2025 20 Jan 2026

Dossiers sharing a running issue

Dossier Amending Directives 2009/43/EC and 2009/81/EC, as regards the simplification of intra-EU transfers of defence-related products and the simplification of security and defence procurement 2025/0177(COD) · Ordinary legislative procedure 16 Sept 2026 Passed
Dossier Amending Regulations (EC) No 1907/2006, (EC) No 1272/2008, (EU) No 528/2012, (EU) 2019/1021 and (EU) 2021/697 as regards defence readiness and facilitating defence investments and conditions for defence industry 2025/0176(COD) · Ordinary legislative procedure 16 Sept 2026 Passed
Dossier Global role of the euro 2025/2249(INI) · Own-initiative report 15 Sept 2026 Adopted
Dossier Amending Regulation (EU) 2024/1252 2025/0385(COD) · Ordinary legislative procedure 9 Jul 2026 Sent back to committee
Dossier Establishment of the digital euro 2023/0212(COD) · Ordinary legislative procedure 9 Jul 2026 Negotiating mandate approved

Sources & citation

Where the facts on this page come from, and how to cite it.

Permalink: https://news.eu-parl.st-solutions.dev/dossiers/2025-0102?grid=all
Official source: Procedure file (Legislative Observatory, OEIL)
Data source: EP Open Data API: procedure record
Licensed CC BY 4.0.
Retrieved: 25 September 2026

Cite as

European Parliament (2026). “Laying a framework for strengthening the availability and security of supply of critical medicinal products as well as the availability of, and accessibility of, medicinal products of common interest, and amending Regulation (EU) 2024/795”. Dossier, 20 January 2026. procId 2025-0102, reference 2025/0102(COD). EU Parl Watch Research. https://news.eu-parl.st-solutions.dev/dossiers/2025-0102?grid=all (retrieved 25 September 2026). Official source: Procedure file (Legislative Observatory, OEIL), https://oeil.secure.europarl.europa.eu/oeil/en/procedure-file?reference=2025%2F0102(COD). Data: EP Open Data API: procedure record, https://data.europarl.europa.eu/api/v2/procedures/2025-0102 (CC BY 4.0).

BibTeX

@misc{epw-dossier-2025-0102,
  author = {{European Parliament}},
  title = {{Laying a framework for strengthening the availability and security of supply of critical medicinal products as well as the availability of, and accessibility of, medicinal products of common interest, and amending Regulation (EU) 2024/795}},
  year = {2026},
  date = {2026-01-20},
  howpublished = {\url{https://news.eu-parl.st-solutions.dev/dossiers/2025-0102?grid=all}},
  url = {https://news.eu-parl.st-solutions.dev/dossiers/2025-0102?grid=all},
  urldate = {2026-09-25},
  publisher = {EU Parl Watch Research},
  note = {Dossier. procId 2025-0102, reference 2025/0102(COD). Official source: https://oeil.secure.europarl.europa.eu/oeil/en/procedure-file?reference=2025\%2F0102(COD). Data: EP Open Data API: procedure record (CC BY 4.0)}
}