EU pharma package: legislative timeline
The pharma package is a new directive and a new regulation that together replace the EU's core medicines legislation. This page lists every formal step of the legislative procedure, what is still pending, and what each step means for marketing authorisation holders. For the substance of the changes, see the ten main changes in the new pharmaceutical directive.
Steps in the procedure, newest first
Both acts follow the ordinary legislative procedure: procedure 2023/0132/COD for the directive and 2023/0131/COD for the regulation. Pending steps have no date yet and are listed at the top. Application and transposition dates will be added once the text is published in the Official Journal.
| Date | Step | Institution | What it means for marketing authorisation holders | Source |
|---|---|---|---|---|
| Pending | Publication in the Official Journal and entry into force | Official Journal of the EU | The published text fixes the dates from which each obligation applies. Application and transposition deadlines will be confirmed here once published.See the ten main changes. | Not yet available |
| Pending | European Parliament plenary vote | European Parliament | Parliament votes at second reading on the texts as adopted by the Council. The indicative plenary date is 23 November 2026. | European Parliament Legislative Observatory: Procedure file 2023/0132(COD), Union code relating to medicinal products for human use |
| Latest step | European Parliament second reading opens | European Parliament | The Council's position is announced in plenary and referred to the public health committee, which published its draft recommendation on 12 October. | European Parliament Legislative Observatory: Procedure file 2023/0132(COD), Union code relating to medicinal products for human use |
| Council adoption | Council of the EU | The Council formally adopts the directive and the regulation. The acts still need the Parliament's vote before publication.See the ten main changes and the new pharmaceutical regulation. | Council of the EU: Position at first reading on the Directive on the Union code relating to medicinal products for human use, adopted 28 September 2026 (ST 7106/2/26 REV 2) | |
| Provisional political agreement | Council and European Parliament | Negotiators agree the substance of both acts. The compromise texts are the basis for planning, but are not yet law.See the ten main changes and the new pharmaceutical regulation. | Council of the EU: 'Pharma package': Council and Parliament reach a deal (press release, 11 December 2025) | |
| Council negotiating position | Council of the EU | Member States agree their position, opening negotiations (trilogues) with Parliament. | Council of the EU: Council agrees its position on the pharma package (press release, 4 June 2025) | |
| European Parliament first-reading position | European Parliament | Parliament adopts its amendments to both proposals, setting its negotiating position. | EUR-Lex: Procedure 2023/0132/COD, Directive on the Union code relating to medicinal products for human use (COM(2023) 192) | |
| Commission proposal | European Commission | The Commission proposes a new directive and regulation to replace Directive 2001/83/EC and Regulation (EC) No 726/2004. Nothing changes for marketing authorisation holders yet. | European Commission: Reform of the EU pharmaceutical legislation |
- Pending
Publication in the Official Journal and entry into force
Official Journal of the EU
The published text fixes the dates from which each obligation applies. Application and transposition deadlines will be confirmed here once published.See the ten main changes.
Source: Not yet available
- Pending
European Parliament plenary vote
European Parliament
Parliament votes at second reading on the texts as adopted by the Council. The indicative plenary date is 23 November 2026.
- Latest step
European Parliament second reading opens
European Parliament
The Council's position is announced in plenary and referred to the public health committee, which published its draft recommendation on 12 October.
Council adoption
Council of the EU
The Council formally adopts the directive and the regulation. The acts still need the Parliament's vote before publication.See the ten main changes and the new pharmaceutical regulation.
Provisional political agreement
Council and European Parliament
Negotiators agree the substance of both acts. The compromise texts are the basis for planning, but are not yet law.See the ten main changes and the new pharmaceutical regulation.
Council negotiating position
Council of the EU
Member States agree their position, opening negotiations (trilogues) with Parliament.
Source: Council of the EU: Council agrees its position on the pharma package (press release, 4 June 2025)
European Parliament first-reading position
European Parliament
Parliament adopts its amendments to both proposals, setting its negotiating position.
Commission proposal
European Commission
The Commission proposes a new directive and regulation to replace Directive 2001/83/EC and Regulation (EC) No 726/2004. Nothing changes for marketing authorisation holders yet.
Source: European Commission: Reform of the EU pharmaceutical legislation
What happens after publication
The published acts will state when they enter into force and from when each provision applies. The two acts then work differently. The new pharmaceutical regulation applies directly in every Member State from the dates it sets. The directive has to be transposed into national law by each Member State within the period the directive sets, so national rules and timing can still differ in the detail.
Entry into force is not the same as application. Acts of this kind usually apply some time after they enter into force and include transitional provisions for products already on the market, and several obligations depend on implementing or delegated acts and EMA guidance that follow later. Until the text is published, we do not state application deadlines on these pages.
Each of these steps can change what your team has to do and when. Regunaut Alerts monitors updates from EMA, the Commission and national authorities so the next step reaches you the day it happens.
Sources
- European Parliament Legislative Observatory: Procedure file 2023/0132(COD), Union code relating to medicinal products for human use
- Council of the EU: Position at first reading on the Directive on the Union code relating to medicinal products for human use, adopted 28 September 2026 (ST 7106/2/26 REV 2)
- Council of the EU: 'Pharma package': Council and Parliament reach a deal (press release, 11 December 2025)
- Council of the EU: Council agrees its position on the pharma package (press release, 4 June 2025)
- EUR-Lex: Procedure 2023/0132/COD, Directive on the Union code relating to medicinal products for human use (COM(2023) 192)
- European Commission: Reform of the EU pharmaceutical legislation
- Council of the EU: The pharma package, new EU rules on medicines (policy page)
- EUR-Lex: Procedure 2023/0131/COD, Regulation on Union procedures for the authorisation and supervision of medicinal products (COM(2023) 193)