EU Pharma Package : SANT Committee Approves Directive Text

On March 18, 2026, the European Parliament's Committee on Public Health (SANT) approved the text agreed during early second-reading interinstitutional negotiations on the directive on medicinal products for human use, procedure 2023/0132(COD). The vote locks in the political deal struck at trilogue on December 11, 2025, and confirmed by Coreper on March 6, 2026. The next recorded step is the Council's formal first-reading position, with an indicative plenary sitting date forecast for November 11, 2026.

The directive is one half of the EU pharmaceutical package, the largest overhaul of EU medicines law in more than 20 years. It will repeal Directive 2001/83/EC and Directive 2009/35/EC and sit alongside the companion regulation under procedure 2023/0131(COD). Once published in the Official Journal, the new regime reorders regulatory data protection, EMA committee architecture, marketing authorisation validity, environmental risk assessment and antimicrobial stewardship for every medicine placed on the market in the 27 Member States.

What did the SANT committee approve on March 18, 2026?

The SANT committee, under rapporteur Dolors Montserrat (EPP), endorsed the consolidated text negotiated with the Council during early second-reading trilogues. The next day, March 19, 2026, the Council's Coreper letter confirming the interinstitutional agreement was filed under reference GEDA/A/(2026)201324, closing the committee-level sign-off on the Parliament side. The procedure file now reads "Awaiting Council's 1st reading position", the formal step before the joint text returns to plenary.

This is not a new substantive round. The political agreement was reached on December 11, 2025; the March 2026 moves convert it into an adopted act. The EP first-reading position of April 10, 2024 was adopted by 495 to 57, with 45 abstentions, so the March 18, 2026 vote is an early second-reading approval of a text already negotiated with the Council, not a fresh amendable draft.

What changes for marketing authorisation holders once the directive enters into force?

The reform rewrites the baseline incentives for innovative medicines. The minimum regulatory data protection period becomes 8 years, split into 6 years of data protection and 2 years of market protection, with three top-ups: an additional 2 years if launched in all Member States covered by the marketing authorisation, an additional 6 months for unmet medical need, and an additional 6 months where comparative clinical trials are conducted. Generics and biosimilars gain faster entry lanes off those calibrated periods.

EMA's human medicines committees are cut from five to two: CHMP and PRAC. The scientific assessment timeline is compressed from 210 to 180 days, and the Commission decision step from 67 to 46 days. Marketing authorisations become valid for an unlimited period by default, removing the routine 5-year renewal cycle. Applicants for pricing and reimbursement must submit within 12 months of a Member State request, extended to 24 months for SMEs, with the explicit objective of cutting access inequality across the Union.

How does the directive change environmental, antimicrobial and pharmacovigilance rules?

Environmental risk assessment is strengthened: risk mitigation measures covering emissions to air, water and soil must address the entire lifecycle of the medicinal product. Antimicrobials carry new prescription discipline, pack-size rules aligned to treatment duration, and progressive rollout of unit dose pre-cut blisters in hospitals and pharmacies. A medicinal product is prescription-only where it is an antimicrobial with identified AMR risk, or contains a substance that is persistent, bioaccumulative and toxic, very persistent and very bioaccumulative, persistent mobile and toxic, or very persistent and very mobile.

Pharmacovigilance obligations expand: Member States must record all suspected adverse reactions on their territory, including those from incorrect administration or dispensation, and route them through Eudravigilance into periodic safety update reports. The package leaflet becomes available electronically and in paper, with Member States allowed to move to electronic-only product information. The Commission is tasked to assess online pharmaceutical advertising and adopt specific rules on promotional practices online.

What is the timeline from committee approval to application?

The directive is binding as to the result but requires national transposition, so Member State rule books absorb the new obligations through national medicines codes. Until OJ publication, Directive 2001/83/EC remains the applicable reference text.

A continuous, per-jurisdiction monitoring setup would have surfaced this SANT approval and the Coreper letter the day they posted on the Legislative Observatory. Obsidian tracks the EU pharmaceutical package lineage end to end, from proposal through trilogue to committee sign-off and plenary vote.

Take advantage of this real-time watch

Three actions belong on this quarter's agenda. First, audit your portfolio against the new 8-year baseline plus the three top-up periods to model exclusivity per product. Second, brief regulatory affairs on the compressed EMA timelines (180-day assessment, 46-day Commission decision, unlimited MA validity) so submission planning shifts to the new cadence. Third, brief environmental and pharmacovigilance leads on lifecycle ERA scope, antimicrobial pack-size rules, and Eudravigilance reporting expansion. Obsidian keeps the OEIL file and OJ publication date current, so the next move is a decision, not a search.