What we publish on medicines and when

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
• Changes to centralised marketing authorisations
• EU referrals
• Other documents and procedures

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 page	Friday 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 document	CHMP meeting highlights and referrals	Friday 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 statement	Medicine’s EPAR page	2 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 page	2 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 page	Within 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 page	2 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 medicines	Outcomes of imposed non-interventional post-authorisation safety studies	Within 2 months after conclusion of PASS
Scientific conclusions, amendments to product information and implementation timetable’	Outcomes of imposed non-interventional post-authorisation safety studies	Within 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 page	Within 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	CAT: Agendas, minutes and reports COMP: Agendas, minutes and meeting reports PDCO: Agendas, minutes and 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 document	Location	Publication 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.