Reliance for post-authorisation changes: guidance for the pharmaceutical industry

EMA makes available guidance on how pharmaceutical companies can apply to a pilot programme that enables them to use reliance to submit post-authorisation changes simultaneously to multiple countries outside the European Union.

For more information, see:

• Reliance for post-authorisation changes pilots

How to apply

EMA invites pharmaceutical companies interested in participating in a pilot to contact EMA at [e-mail].

Applicants must submit the same documents to all participating national authorities, as indicated below:

• Variation package, as used in the EU
• EMA's Committee for Medicinal Products for Human Use (CHMP) final assessment report and approval letter
• An overview of the pilot and information about post-authorisation changes detailed in the cover letter or in a questions and answers document. If applicable, it can also include information on previous inspections related to the change.

Applicants can also submit a question-and-answer document. It should contain an overview of the pilot and details about the post-approval changes. If applicable, it can also cover any information on good compliance practices.

They should comply with mandatory local requirements and respect the classification of post-authorisation changes set by each participating national authority.

National authorities have the option to fully or partially rely on EMA's assessment. They must still adhere to their own regulatory and legal frameworks.

They should also try to align country-specific requirements to EMA's documentation requirements.

Early dialogue and clear communication between the applicant and national authorities is key for the success of a pilot.

Pilot steps

The timeline below describes the recommended steps of a pilot.

The steps can be split into two phases:

• Engagement - where applicants present a pilot to national authorities
• Execution - where the national authorities assess the post-authorisation changes and make their decision

These steps are expected to take no longer than 6 months.

However, as national competent authorities conduct accelerated assessments, decisions can take less time.

1. Applicant interested in a pilot contacts EMA

   Applicant should provide EMA with a high-level overview of the pilot and details about the post-authorisation changes

2. Pre-submission meeting between EMA and applicant (optional)

   Meeting to discuss the pilot programme

3. Applicant engages with national authorities

   Applicant checks the interest of national authorities in participating in the pilot

4. Kick-off meeting between applicant and national authorities (optional)

   National authorities receive information on the pilots and post-authorisation changes

5. Applicant submits documentation to all national authorities per their regular submission processes

   Applicant shares the same documentation to all national authorities, including variation package, EMA assessment report, approval letter, questions and answers, and good manufacturing practices certificate (if needed)

6. National authorities review submitted documents and ask questions to the applicant

   National authorities share their questions with the applicant.

7. Applicant replies to the questions from national authorities

   Applicant can optionally share responses to all received questions with all national authorities, who can use it to support their own reviews

8. National authorities make their independent decisions

   Approval or refusal of post-authorisation changes
9. Show more 5 itemsHide 5 items

EMA support

If required, EMA can hold pre-submission meetings to discuss a pilot.

If needed, it can also:

• attend a pilot's kick-off meeting alongside WHO - in these meetings, applicants provide national authorities with details on the post-authorisation changes, timelines and pilot logistics;
• offer national authorities the opportunity to seek clarifications on its assessment report from the team that produced the report and the rapporteur;
• provide applicants with an invitation letter which they can share with interested national authorities;

Furthermore, EMA supports the pilots with other activities, including:

• informal discussions with applicants to discuss the pilots and high-level principles of reliance;
• ad-hoc updates on the progress of the pilots;
• discussions in relevant platforms on lessons learned, ways forward and reliance models.

Page update history

An update log is available to show the date and summary of changes to this webpage. It does not include updates to linked documents or minor edits like typos or broken link fixes.

The tracking of updates begins in August 2026.

See update history

13 August 2026

• New page with guidance for pharmaceutical companies on how to participate in the reliance post-authorisation pilots. 
• The content on this page was previously available on the Reliance for post-authorisation changes pilots page.