On 17 September 2026, the Council published its first-reading positions on the proposed EU Pharmaceutical Regulation and Directive. The texts largely preserve the compromise reached in December 2025 described in our earlier alert, and provide the clearest indication yet of the framework that will soon be adopted.
Last steps of the legislative procedure
The legislative process is now at a very advanced stage. Although there is no official information on timings, it is expected that publication in the Official Journal will occur in November 2026 or December 2026 at the latest. Below is an overview of key timings to bear in mind.
Date of entry into force
- The Regulation and Directive will enter into force 20 days after publication in the Official Journal.
Date of application
- As a general rule, most provisions are expected to apply 24 months after entry into force. This would point to application around Q4 2028.
- There are however some exceptions, as both the Directive and Regulation contain important transitional arrangements.
Immediate application
The following provisions will become applicable upon entry into force of the Regulation (i.e. 20 days after publication in the OJ – expected before end of 2026):
- Transferable Exclusivity Voucher for priority antimicrobials
- Regulatory sandboxes for centrally authorised products
- Provisions concerning the supply of critical medicinal products
- Provisions concerning international cooperation arrangements between EMA and third country authorities
- Specific provisions concerning EMA’s expenditure and grants
Six months from the date of entry into force
Provisions concerning the monitoring and management of shortages and critical shortages will become applicable 6 months from the date of entry into force of the Regulation (i.e. likely Q2 2027). These provisions include:
- Notification obligations
- Setting up of shortage prevention plans
1 year from the date of entry into force
Market access provisions allowing Member States to request the marketing authorisation holder to place a medicinal product on their territory and to supply it in sufficient quantities will become applicable one year after the Regulation and Directive enter into force (i.e. likely Q4 2027).
As obtaining marketing authorisation can take over a year, these requirements are expected to become relevant for applications submitted from early 2027 onwards. Failure to comply with this requirement could potentially lead to loss of market protection or financial penalties.
Provisions applicable six months from the date of application of the Regulation (likely Q2 2029)
- EMA’s Register for orphan medicinal products
Transitional provisions regarding ongoing procedures, regulatory data and market protection periods and orphan market exclusivity
- Marketing authorisation applications, orphan designations and PIPs/waivers/deferrals submitted before the date of entry into force of the Directive or date of application of the Regulation shall be completed in accordance with the ‘old/current’ legislation. This means that applications that are ongoing at that point will be completed under the old legislation. Only applications submitted from Q4 2028 onwards will be processed in accordance with the new rules.
- The new regulatory periods of data and market protection will apply to reference medicinal products for which the marketing authorisation application is submitted 24 months after the date of entry into force of the Directive or date of application of Regulation (e.g. expected Q4 2028).
- The new periods of orphan market exclusivity will apply to orphan products for which the MA application is submitted after the date of application of the Regulation (e.g. expected Q4 2028).
In parallel to all of the above, the Directive will require transposition into national law, which may introduce additional timing variability across Member States.
Implementing measures
A significant number of implementing and delegated acts are expected to be adopted. In practice, this will result in a phased implementation where the core legislative framework will coexist with a progressively expanding layer of secondary legislation and guidance. As a result, certain key operational aspects (e.g. data requirements, technical standards or procedural details) will only be clarified over time, potentially creating some uncertainty during the transition period.
This staged rollout also implies that certain provisions may become operational before the full regulatory ecosystem is defined, requiring companies to anticipate evolving compliance requirements and adapt to successive regulatory updates.
