What we publish on medicines and when

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The European Medicines Agency (EMA) publishes information on human medicines at various stages of their lifecycles, from early development through initial evaluation to post-authorisation changes, safety reviews and withdrawals of authorisation.

EMA has published a guide to the different types of information stakeholders can expect on this website about centrally and non-centrally authorised medicines, including the publication times and location:

Guide to information on human medicines evaluated by EMA

For the Committee for Medicinal Products for Human Use (CHMP) and the Pharmacovigilance Risk Assessment Committee (PRAC), EMA publishes meeting highlights to communicate information of major public interest, usually the day after their meetings have ended.

As a matter of good practice, marketing authorisation holders, applicants and third parties should wait until EMA communication is published before publishing their own communication related to the committee’s outcome. 

In line with Good Pharmacovigilance Practice (GVP) Module XV, EMA gives advance notice of its safety-related publications to national competent authorities, the European Commission and the concerned marketing authorisation holders. 

Marketing authorisation holders are also obliged to inform the Agency and relevant national competent authorities of their intention to publish information on the safety of medicines.

Table of contents


Applications for centralised marketing authorisation

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Table 1: Medicines under initial evaluation

Type of document

Location

Publication time

List of medicines that are under evaluation

Medicines under evaluation

Monthly

COMP monthly meeting reports (for orphan medicines)

COMP page

Week following COMP plenary

 

Table 2: Positive opinions

Type of document

Location

Publication time

Summary of opinion

CHMP meeting highlights and pending European Commission (EC)  decisions

(document moved to medicine’s EPAR page after EC decision)

Friday following CHMP plenary

Dedicated press release (for selected medicines)

EMA homepage and CHMP meeting highlights

Friday following CHMP plenary

EPAR

EPAR summary

Medicine’s EPAR page

2 weeks after EC decision

Product information

Medicine’s EPAR page (under tab ‘Product information’)

List of all authorised presentations

Medicine’s EPAR page (under tab ‘Product information’)

Public assessment report

Medicine’s EPAR page (under tab ‘Assessment history’)

Communication on medication error prevention (if applicable)

Recommendations on medication errors page

2 weeks after EC decision

Summary of the review of orphan designation (for orphan medicines)

Rare disease designations page (under tab ‘Review of designation’)

2 weeks after EC decision

 

Table 3: Negative opinions

Type of document

Location

Publication time

Refusal questions and answers (Q&A)

CHMP meeting highlights and pending EC decisions

(Q&A moved to medicine’s EPAR page after EC decision)

Friday following CHMP plenary

Refusal public assessment report

Medicine’s EPAR page (under tab ‘Assessment history’)

2 weeks after EC decision

 

Table 4: Re-examination of opinions

Type of document

Location

Publication time

Re-examination questions and answers (Q&A, for both positive and negative outcomes)

CHMP meeting highlights and pending EC decisions

(Q&A moved to medicine’s EPAR page after EC decision)

Friday following CHMP plenary

Summary of opinion (for positive outcomes only)

CHMP meeting highlights and pending EC decisions

Friday following CHMP plenary

After the European Commission decision, depending on the outcome of the re-examination, the same set of documents as for positive and negative opinions will also be published (see tables 2 and 3 above).

Table 5: Withdrawal of applications

Type of document

Location

Publication time

Withdrawal Q&A

CHMP meeting highlights and withdrawn applications

Friday following upcoming CHMP plenary

Withdrawal letter

Withdrawn applications (under tab ‘All documents’)

Friday following upcoming CHMP plenary

Withdrawal public assessment report

Withdrawn applications (under tab ‘All documents’)

Within 3 months of receipt of withdrawal letter

 

Changes to centralised marketing authorisations

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Table 6: Extensions of indication

Type of document

Location

Publication time

Positive opinions

Summary of opinion (excluding generics and biosimilars)

CHMP meeting highlights and pending EC decisions
(document moved to medicine’s EPAR page after EC decision)

Friday following CHMP plenary

Dedicated press release (for selected extensions of indication)

EMA homepage and CHMP meeting highlights

Friday following CHMP plenary

Update of EPAR documents (product information, procedural steps document and, if applicable, EPAR summary and list of all authorised presentations)

Medicine’s EPAR page

2 weeks after EC decision

Summary of the review of orphan designation (if applicable)

Rare disease designations (under tab ‘Review of designation’)

2 weeks days after EC decision

Public assessment report

Medicine’s EPAR page (under tab ‘Assessment history’)

2 weeks days after EC decision

Negative opinions

Refusal Q&A

CHMP meeting highlights and pending EC decisions
(Q&A moved to medicine’s EPAR page after EC decision)

Friday following CHMP plenary

Update of procedural steps document

Medicine’s EPAR page (under tab ‘Assessment history’)

5 weeks after CHMP opinion

Refusal public assessment report

Medicine’s EPAR page (under tab ‘Assessment history’)

5 weeks after CHMP opinion

Re-examinations 
After the European Commission (EC) decision, depending on the outcome of the re-examination, the same set of documents as for positive or negative opinions on extension of indication will be published.

Re-examination Q&A (for both positive and negative outcomes)

CHMP meeting highlights and pending EC decisions
(Q&A moved to medicine’s EPAR page after EC decision)

Friday following CHMP plenary

Summary of opinion (for positive outcomes only)

CHMP meeting highlights and pending EC decisions

Friday following CHMP plenary

Withdrawal

Withdrawal Q&A

Withdrawn applications

Friday following next CHMP plenary

Withdrawal letter

Withdrawn applications (under tab ‘All documents’)

Friday following next CHMP plenary

Withdrawal public assessment report

Withdrawn applications (under the tab ‘All documents’)

Within 3 months of receipt of withdrawal letter

Update of procedural steps document

Medicine’s EPAR page (under tab ‘Assessment history’)

Within 3 months of receipt of withdrawal letter

Changes of scope during extension of indication applications

Q&A for change in scope

Medicine’s EPAR page

Friday following CHMP plenary

Update of procedural steps document

Medicine’s EPAR page (under tab ‘Assessment history’)

2 weeks after EC decision

Updated product information

Medicine’s EPAR page (under tab ‘Product information’)

2 weeks after EC decision

Public assessment report

Medicine’s EPAR page (under tab ‘Assessment history’)

2 weeks after EC decision

 

Table 7: Other variations, annual re-assessments, renewals and line extensions

Type of document

Location

Publication time

Summary of opinion for:

  • changes to contra-indications
  • changes that significantly alter the medicine’s use

CHMP meeting highlights and pending EC decisions

Friday following CHMP plenary

Public health communication (for selected changes of major public health importance)

CHMP meeting highlights and medicine’s EPAR page

Friday following CHMP plenary

Update of EPAR documents (product information, procedural steps document and, if applicable, EPAR summary and list of all authorised presentations)

Medicine’s EPAR page

2 weeks after EC decision or 8-10 weeks after CHMP opinion/notification, as applicable

Public assessment reports (for those changes that are of significant clinical relevance)

Medicine’s EPAR page (under the tab ‘All documents’)

2 weeks after EC decision or 5 weeks after CHMP opinion/notification, as applicable

 

Table 8: Withdrawal/expiry of centralised marketing authorisations

Type of document

Location

Publication time

Public statement

Medicine’s EPAR page

At time of withdrawal or expiry of marketing authorisation

EPAR documents watermarked

Medicine’s EPAR page

At time of withdrawal or expiry of marketing authorisation

 

EU referrals

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Table 9: Article 20, 31 and 107i referrals

Type of document

Location

Publication time

Announcement of start of referral

CHMP meeting highlights or PRAC meeting highlights and referrals

Friday following PRAC or CHMP plenary where referral is started

Notification
Draft list of medicines
List of questions
Timetable
Rationale for Art. 107i procedure

Referrals (under tab ‘All documents’)

Friday following PRAC or CHMP plenary where referral is started

PRAC list of questions addressed to stakeholders (for Art. 107i referrals)

Referrals (under tab ‘Data submission’)

Friday following PRAC plenary where referral is started

Summary of PRAC recommendation (when PRAC is involved)

PRAC meeting highlights and referrals

Friday following PRAC plenary where PRAC recommendation is adopted

Public health communication

EMA homepage, CHMP meeting highlights (if applicable) and referrals

Friday following CHMP or CMDh plenary where CHMP opinion or CMDh position is adopted

Text of the updated product information in English

Referrals (under tab ‘All documents’)

Friday following CHMP or CMDh plenary where CHMP opinion or CMDh position is adopted

Timetable for implementation of CMDh consensus position

Referrals (under tab ‘All documents’)

Friday following CMDh plenary where CMDh consensus position is adopted

Public assessment report

Referrals (under tab ‘All documents’)

1 week after EC decision or CMDh consensus position

Annexes

Referrals (under tab ‘All documents’)

4 weeks after EC decision or 8 weeks after CMDh consensus position

Update of EPAR documents (product information, procedural steps document and, if applicable EPAR summary and list of all authorised presentations) if CAPs are involved

Medicine’s EPAR page

2 weeks after EC decision

 

Table 10: Article 13(2), 29(4) and 30 referrals

Type of document

Location

Publication time

Table ‘Start of community reviews’

CHMP meeting highlights

Friday following CHMP plenary where referral is started

Announcement of start of referral (for Article 30 referrals only)CHMP meeting highlights or PRAC meeting highlights and referrals pageFriday following CHMP plenary where referral is started
Notification
Draft list of medicines
List of questions
Timetable
(for Article 30 referrals only)
Referrals page (under tab ‘All documents’)Friday following CHMP plenary where referral is started
Questions and answers documentCHMP meeting highlights and referralsFriday following CHMP plenary where CHMP opinion is adopted
Text of the updated product information
in English (if applicable)
Referrals (under tab ‘All documents’)Friday following CHMP plenary where CHMP opinion is adopted

Public assessment report

Referrals (under tab ‘All documents’)1 week after EC decision

Annexes

Referrals (under tab ‘All documents’)

4 weeks after EC decision

Table 11: Article 5(3) opinions

Type of document

Location

Publication time

Table ‘Start of community reviews’

CHMP meeting highlights

Friday following CHMP plenary where referral is started

Press release (for selected opinions)

EMA homepage, CHMP meeting highlights

Friday following CHMP plenary where CHMP opinion is adopted

Public assessment report

Article 5(3) opinions

15 days after CHMP opinion

 

Table 12: Article 29(Paediatrics) opinions

Type of document

Location

Publication time

Summary of CHMP conclusions

Referrals

Friday following CHMP plenary where CHMP opinion is adopted

Public assessment report

Referrals (under tab ‘All documents’)

15 days after CHMP opinion

 

Other documents and procedures

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Table 13: Orphan designations

Type of document

Location

Publication time

Public summary of opinion on orphan designation

Rare disease (orphan) designations

4 weeks after EC decision on orphan designation

Summary of review of orphan designation

Rare disease (orphan) designations (under tab ‘Review of designation’)

2 weeks after EC decision

Summary of the review of orphan designation following Member State request

Rare disease (orphan) designations (under tab ‘Review of designation’)

6-8 weeks after COMP opinion

 

Table 14: ATPM classification

Type of document

Location

Publication time

Summary of scientific recommendations on classification of advanced-therapy medicinal products

Summaries of scientific recommendations on classification of advanced-therapy medicinal products

After CAT conclusion

 

Table 15: Paediatric investigation plans (PIPs)

Type of document

Location

Publication time

Decisions on PIPs and waivers

Opinions and decisions on paediatric investigation plans

6-8 weeks after EMA decision

Summary of PDCO evaluation

Opinions and decisions on paediatric investigation plans

6-8 weeks after EMA decision

Compliance check outcome

Opinions and decisions on paediatric investigation plans

Twice a year

Compliance statementMedicine’s EPAR page2 weeks after EC decision or 4-5 weeks after CHMP opinion/notification, as applicable

 

Table 16: Safety signals

Type of document

Location

Publication time

PRAC recommendations on signals

PRAC recommendations on safety signals

Within a month of PRAC plenary

Recommendations for updates of product information (if applicable)

PRAC recommendations on safety signals

Within a month of PRAC plenary

 

Table 17: Medicines under additional monitoring

Type of document

Location

Publication time

List of medicines under additional monitoring

List of medicines under additional monitoring

Monthly

 

Table 18: Compassionate use

Type of document

Location

Publication time

Summary of compassionate use

Compassionate use

After CHMP opinion

Conditions of use, conditions for distribution and patients targeted and conditions for safety monitoring

Compassionate use

After CHMP opinion

Dedicated press release (for selected opinions)

EMA homepage and CHMP meeting highlights

Friday following CHMP plenary

 

Table 19: Shortages

Type of document

Location

Publication time

Shortages catalogue

Shortages catalogue

At time of shortage and when shortage is resolved

 

Table 20: Periodic safety update reports

Type of document

Location

Publication time

PSUSAs for active substances found only in centrally authorised medicines  
Update of EPAR documents (product information, procedural steps document and, if applicable EPAR summary and list of all authorised presentations)Medicine’s EPAR page2 weeks after EC decision
Document ‘The scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation’ (for PSUSAs that lead to changes to product information)Medicine’s EPAR page (under tab ‘Assessment history’)2 weeks after EC decision
Public assessment report (for PSUSAs that are of significant clinical relevance)Medicine’s EPAR page (under tab ‘Assessment history’)2 weeks after EC decision
PSUSAs for active substances found only in nationally authorised medicines  

List of medicines

Outcomes of periodic safety update report single assessments

Within 1 week or 2 months of conclusion of PSUSA (for maintenance or variation, respectively)

Scientific conclusions and grounds for variation to the terms of the marketing authorisations (if applicable)

Outcomes of periodic safety update report single assessments

Within 2 months after conclusion of PSUSA

Public assessment report (for PSURs that are of significant clinical relevance)Periodic safety update report single assessments pageWithin 2 months after conclusion of PSUSA

 

Table 21: Imposed non-interventional post-authorisation safety studies

Type of document

Location

Publication time

PASS for active substances found only in centrally authorised medicines
Update of EPAR documents (product information, procedural steps document and, if applicable, EPAR summary and list of all authorised presentations)Medicine’s EPAR page2 weeks after EC decision
Document ‘Scientific conclusions, amendments to product information and implementation timetable’Medicine’s EPAR page (under tab ‘Assessment history’)2 weeks after EC decision
Public assessment report (for PASS that are of significant clinical relevance)Medicine’s EPAR page (under tab ‘Assessment history’)2 weeks after EC decision
PASS for active substances found only in nationally authorised medicines
List of medicinesOutcomes of imposed non-interventional post-authorisation safety studiesWithin 2 months after conclusion of PASS
Scientific conclusions, amendments to product information and implementation timetable’Outcomes of imposed non-interventional post-authorisation safety studiesWithin 2 months after conclusion of PASS
Public assessment report (for PASS that are of significant clinical relevance)Outcomes of imposed non-interventional post-authorisation safety studies pageWithin 2 months after conclusion of PASS

 

Table 22: Medicines for use outside the EU (Article 58)

Type of document

Location

Publication time

Same documents as for centrally authorised medicines (see tables 1 to 7)

Opinions on medicines for use outside the European Union

Within 2 months of CHMP opinion

 

Table 23: Ancillary medicinal substances

Type of document

Location

Publication time

Consultation public assessment report

Ancillary medicinal substances

2 weeks after notified body confirms issue of CE mark

 

Table 24: Agendas, minutes and reports of meetings of EMA’s scientific committees

Type of document

Location

Publication time

Committees agendas

Committees

Before start of Committee plenary

Committees minutes

Committees

After Committee plenary where minutes are adopted

CHMP meeting highlights

EMA homepage and CHMP: Agendas, minutes and highlights

Friday following CHMP plenary

PRAC meeting highlights

EMA homepage and PRAC: Agendas, minutes and highlights

Friday following PRAC plenary

CAT, COMP and PDCO monthly meeting reports

Week following Committee plenary

Table 25: Medical literature monitoring

Type of document

Location

Publication time

Medical literature monitoring: substance and herbal substance groups

Medical literature monitoring

Annually

 

Table 26: Clinical data publication
Type of documentLocationPublication time
Clinical reports as per the Agency’s policy on the publication of clinical data (Policy 0070)Clinical data website

Marketing authorisation applications, line extensions and extensions of indication:

Within 60 days after EC decision and following publication of the EPAR

 

Article 58 applications:

Within 150 days after the CHMP opinion

 

Withdrawn applications:

Within 150 days after the receipt of the withdrawal letter

Please note that there will be some delay in publishing clinical reports submitted in 2015 and 2016 while the Agency processes these documents for publication.

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