What we publish on medicines and when
Table of contents
EMA publishes information on medicines at various stages of their lifecycles, from early development through initial evaluation to post-authorisation changes, safety reviews and withdrawals of authorisation.
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During the COVID-19 pandemic, EMA is implementing exceptional transparency measures on treatments and vaccines for COVID-19. For more information, see Transparency: exceptional measures for COVID-19 medicines.
Overview of publications and their location
Applications for centralised marketing authorisation
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Publication type Publication time Location List of medicines that are under evaluation Monthly Medicines for human use under evaluation COMP monthly meeting reports (for orphan medicines) Week following COMP plenary COMP: Agendas, minutes and meeting reports -
Publication type Publication time Location Summary of opinion Friday following CHMP plenary - CHMP meeting highlights
- Medicines search: summaries of opinion (application type: initial authorisation; opinion status: positive)
(document moved to medicine's EPAR page after EC decision)
Dedicated press release (for selected medicines) Friday following CHMP plenary European public assessment report (EPAR)
This includes the:
- medicine overview;
- product information;
- list of all authorised presentations;
- public assessment report;
- risk management plan (or summary of risk management plan)
2 weeks after EC decision
Medicines search: EPARs Communication on medication error prevention (if applicable) 2 weeks after EC decision Recommendations on medication errors Orphan maintenance or withdrawal assessment report (for orphan medicines) 2 weeks after EC decision Medicines search: orphan designations (on medicine page under 'Review of designation') -
Publication type Publication time Location Refusal questions and answers (Q&A) Friday following CHMP plenary - CHMP meeting highlights
- Medicines search: summaries of opinion (application type: initial authorisation; opinion status: negative)
(document moved to medicine's EPAR page after EC decision)
Refusal public assessment report 2 weeks after EC decision Medicines search: EPARs (on medicine page under 'Assessment history') -
Publication type Publication time Location Re-examination questions and answers (for positive and negative outcomes) Friday following CHMP plenary
- CHMP meeting highlights
- Medicines search: summaries of opinion (application type: initial authorisation)
(document moved to medicine's EPAR page after EC decision)
Summary of opinion (for positive outcomes only) Friday following CHMP plenary After the EC decision, depending on the outcome of the re-examination, EMA publishes the same set of documents as for positive and negative opinions.
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Publication type Publication time Location Withdrawal questions and answers Friday following upcoming CHMP plenary Withdrawal letter Friday following upcoming CHMP plenary Medicines search: withdrawn applications (withdrawal type: initial authorisation) Withdrawal public assessment report Within 3 months of receipt of withdrawal letter Medicines search: withdrawn applications (withdrawal type: initial authorisation)
Changes to centralised marketing authorisations
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Positive opinions
Publication type Publication time Location Summary of opinion Friday following CHMP plenary - CHMP meeting highlights
- Medicines search: summaries of opinion (application type: post-authorisation; opinion status: positive)
(document moved to medicine's EPAR page after EC decision)
Dedicated press release
(for selected extensions of indication)Friday following CHMP plenary Update of EPAR documents, including:
- product information;
- procedural steps document;
- medicine overview (if applicable);
- list of all authorised presentations (if applicable);
- updated risk management plan (or summary of risk management plan) (if applicable).
2 weeks after EC decision Orphan maintenance or withdrawal assessment report
(if applicable)2 weeks after EC decision - Medicines search: orphan designations (on medicine page under 'Review of designation')
Public assessment report 2 weeks after EC decision Medicines search: EPARs (on medicine page under 'Assessment history')
Negative opinions
Publication type Publication time Location Refusal Q&A Friday following CHMP plenary - CHMP meeting highlights
- Medicines search: summaries of opinion (application type: post-authorisation; opinion status: negative)
(document moved to medicine's EPAR page after EC decision)
Update of procedural steps document 4–5 weeks after CHMP opinion Medicines search: EPARs (on medicine page under 'Assessment history')
Refusal public assessment report 4–5 weeks after CHMP opinion Medicines search: EPARs (on medicine page under 'Assessment history')
Re-examinationsAfter 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.
Publication type Publication time Location Re-examination Q&A (for both positive and negative outcomes) Friday following CHMP plenary - CHMP meeting highlights
- Medicines search: summaries of opinion (application type: post-authorisation)
(Q&A moved to medicine's EPAR page after EC decision)
Summary of opinion (for positive outcomes only) Friday following CHMP plenary
Withdrawal
Publication type Publication time Location Withdrawal Q&A Friday following CHMP plenary Medicines search: withdrawn applications (withdrawal type: post-authorisation)
Withdrawal letter Friday following CHMP plenary Medicines search: withdrawn applications (withdrawal type: post-authorisation) (on medicine pages under 'All documents')
Withdrawal public assessment report Within 3 months of receipt of withdrawal letter Medicines search: withdrawn applications (withdrawal type: post-authorisation) (on medicine pages under 'All documents')
Update of procedural steps document Within 3 months of receipt of withdrawal letter Medicines search: EPARs (on medicine page under 'Assessment history')
Changes of scope during extension of indication applications
Publication type Publication time Location Q&A for change in scope Friday following CHMP plenary Update of procedural steps document 2 weeks after EC decision Medicines search: EPARs (on medicine page under 'Assessment history')
Updated product information 2 weeks after EC decision Medicines search: EPARs (on medicine page under 'Product information')
Public assessment report 2 weeks after EC decision Medicines search: EPARs (on medicine page under 'Assessment history')
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Publication type Publication time Location Summary of opinion for:
- changes to contra-indications;
- changes that significantly alter the medicine's use.
Friday following CHMP plenary Public health communication
(for selected changes of major public health importance)Friday following CHMP plenary Update of EPAR documents, including:
- product information;
- procedural steps document;
- medicine overview (if applicable);
- list of all authorised presentations (if applicable);
- risk management plan (or risk management plan summary) (if applicable).
2 weeks after EC decision or 4–5 weeks after CHMP opinion / notification, as applicable Public assessment reports
(for those changes that are of particular importance*)2 weeks after EC decision or 4–5 weeks after CHMP opinion / notification, as applicable Medicines search: EPARs (on medicine page under 'All documents')
*EMA may also publish reports for negative or withdrawn applications if evaluation is of particular importance.
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Publication type Publication time Location Public statement At time of withdrawal or expiry of marketing authorisation EPAR documents watermarked At time of withdrawal or expiry of marketing authorisation
Referrals
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Publication type Publication time Location Announcement of start of referral Friday following PRAC or CHMP plenary where referral is started - Notification
- Draft list of medicines
- List of questions
- Timetable
- Rationale for Art. 107i procedure
Friday following PRAC or CHMP plenary where referral is started Medicine search: Referrals (Refferal type: Article 20, 31 and 107i referrals) (on medicine page under 'All documents')
PRAC list of questions addressed to stakeholders (for Art. 107i referrals) Friday following PRAC plenary where referral is started Medicine search: Referrals (Refferal type: Article 107i referrals) (on medicine page under 'Data submission')
Communication on PRAC recommendation (when PRAC is involved) Friday following PRAC plenary where PRAC recommendation is adopted Updated communication Friday following CHMP or CMDh plenary where CHMP opinion or CMDh position is adopted Text of the updated product information in English Friday following CHMP or CMDh plenary where CHMP opinion or CMDh position is adopted Medicine search: Referrals (Refferal type: Article 20, 31 and 107i referrals) (on medicine page under 'All documents')
Timetable for implementation of CMDh consensus position Friday following CMDh plenary where CMDh consensus position is adopted Medicine search: Referrals (Refferal type: Article 20, 31 and 107i referrals) (on medicine page under 'All documents')
Public assessment report 1 week after EC decision or CMDh consensus position Medicine search: Referrals (Refferal type: Article 20, 31 and 107i referrals) (on medicine page under 'All documents')
Annexes 4 weeks after EC decision or 8 weeks after CMDh consensus position Medicine search: Referrals (Refferal type: Article 20, 31 and 107i referrals) (on medicine page under 'All documents')
Update of EPAR documents if CAPs are involved, including:
- product information;
- procedural steps document;
- medicine overview and list of all authorised presentations(if applicable)
2 weeks after EC decision -
Publication type Publication time Location Table ‘Start of community reviews’ Friday following CHMP plenary where referral is started Announcement of start of referral (for Article 30 referrals only) Friday following CHMP plenary where referral is started - Notification
- Draft list of medicines
- List of questions
- Timetable (for Article 30 referrals only)
Friday following CHMP plenary where referral is started Medicine search: Referrals (referral type: Article 13(2), 29(4) and 30 referrals) (on medicine page under 'All documents')
Questions-and-answers document Friday following CHMP plenary where CHMP opinion is adopted Text of the updated product information in English (if applicable) Friday following CHMP plenary where CHMP opinion is adopted Medicine search: Referrals (referral type: Article 13(2), 29(4) and 30 referrals) (on medicine page under 'All documents') Public assessment report 1 week after EC decision Medicine search: Referrals (referral type: Article 13(2), 29(4) and 30 referrals) (on medicine page under 'All documents')
Annexes 4 weeks after EC decision Medicine search: Referrals (referral type: Article 13(2), 29(4) and 30 referrals) (on medicine page under 'All documents')
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Publication type Publication time Location Table ‘Start of community reviews’ Friday following CHMP plenary where referral is started Press release (for selected opinions) Friday following CHMP plenary where CHMP opinion is adopted Public assessment report 15 days after CHMP opinion Article 5(3) opinions on any scientific matter: human medicines
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Publication type Publication time Location Summary of CHMP conclusions Friday following CHMP plenary where CHMP opinion is adopted Medicine search: Referrals (referral type: Article 29 (Paediatrics) referrals) Public assessment report 15 days after CHMP opinion Medicine search: Referrals (referral type: Article 29 (Paediatrics) referrals) (on medicine page under 'All documents')
Other documents and procedures
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Publication type Publication time Location Public summary of opinion on orphan designation 4 weeks after EC decision on orphan designation Medicine search: orphan designations Orphan maintenance / withdrawal assessment report 2 weeks after EC decision Medicine search: orphan designations (on medicine page under 'Review of designation')
Orphan maintenance / withdrawal assessment report following Member State request 6-8 weeks after COMP opinion Medicine search: orphan designations (on medicine page under 'Review of designation')
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Publication type Publication time Location Summary of scientific recommendations on classification of advanced-therapy medicinal products
After CAT conclusion Scientific recommendations on classification of advanced therapy medicinal products
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Publication type Publication time Location Decisions on PIPs and waivers 6-8 weeks after EMA decision Compliance check outcome Twice a year Medicines search: Paediatric investigation plans Compliance statement 2 weeks after EC decision or 4-5 weeks after CHMP opinion / notification, as applicable -
Publication type Publication time Location PRAC recommendations on signals Within a month of PRAC plenary New product information wording (if applicable) Within a month of PRAC plenary -
Publication type Publication time Location List of medicines under additional monitoring Monthly -
Publication type Publication time Location Summary of compassionate use After CHMP opinion - Conditions of use
- Conditions for distribution
- Patients targeted
- Conditions for safety monitoring
After CHMP opinion Dedicated press release (for selected opinions) Friday following CHMP plenary
Public statement on end of compassionate use programme Following notification from company Compassionate use -
Publication type Publication time Location Ongoing medicine shortage At time of shortage Resolved medicine shortage When shortage is resolved Medicines search: Resolved shortages -
Periodic safety update report single assessments (PSUSAs) for active substances in centrally authorised medicines only
Publication type Publication time Location Update of EPAR documents, including:
- product information;
- procedural steps document
- EPAR summary (if applicable)
- list of all authorised presentations (if applicable)
2 weeks after EC decision Medicines search: EPARs (on medicine page)
Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation
(for PSUSAs that lead to changes to product information)2 weeks after EC decision Medicines search: EPARs (on medicine page under 'Assessment history')
Public assessment report
(for PSUSAs that are of significant clinical relevance)2 weeks after EC decision Medicines search: EPARs (on medicine page under 'Assessment history')
PSUSAs for active substances in nationally authorised medicines onlyPublication type Publication time Location List of medicines 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)Within 2 months after conclusion of PSUSA Public assessment report
(for PSURs that are of significant clinical relevance)Within 2 months after conclusion of PSUSA -
Post-authorisation safety studies (PASS) are studies carried out after a medicine has been authorised in order to obtain further information on the medicine's safety, or to measure the effectiveness of risk-management measures. The PRAC assesses both the protocols and the final study results of all imposed non-interventional PASS.
All procedures to assess final results of imposed non-interventional PASS result in a change to the marketing authorisation (i.e. a variation).
The assessment of results from imposed non-interventional PASS for active substances found only in centrally authorised medicines will result in an update of relevant EPAR documents, as described in Section 3.2. A document called Scientific conclusions, amendments to product information and implementation timetable is also published on the medicine’s page in the section ‘Assessment history’.
The outcomes of assessments of imposed non-interventional PASS results for active substances found only in nationally authorised medicines are published on the page Outcomes of imposed noninterventional post-authorisation safety studies within 2 months of the conclusion of the procedure. EMA publishes on this page the List of medicines that were assessed in the PASS together with the Scientific conclusions, amendments to product information and implementation timetable. This latter document is available in all official EU languages. An Assessment report is only published when changes are considered to be of significant clinical relevance.
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Publication type Publication time Location DHPC At the time of dissemination of the DHPC -
Publication type Publication time Location Same documents as for centrally authorised medicines (see 'Applications for centralised marketing authorisations') Within 2 months of CHMP opinion -
Publication type Publication time Location Consultation public assessment report 2 weeks after notified body confirms issue of CE mark Procedural steps and scientific information after initial consultation 2 weeks after finalisation of a post-consultation procedure -
Publication type Publication time Location Medical literature monitoring: substance and herbal substance groups Annually -
Publication type Publication time Location Clinical reports for marketing authorisation applications, line extensions and extensions of indication Within 60 days after EC decision and following publication of the EPAR Clinical reports for medicines for use outside the EU (Article 58 applications) Within 150 days after the CHMP opinion Clinical reports for withdrawn applications Within 150 days after the receipt of the withdrawal letter For more information on EMA's policy on the publication of clinical data, see Clinical data publication.
* temporarily suspended
Overview of publications and their location
Applications for centralised marketing authorisation
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Publication type Publication time Location Summary of opinion Friday following CVMP plenary (document moved to medicine's EPAR page after EC decision)
Dedicated press release (for selected medicines) Friday following CVMP plenary European public assessment report (EPAR)
This includes the:
- medicine overview;
- authorisation details
- product information;
- list of all authorised presentations;
- public assessment report.
1 month after EC decision
Medicines search: EPARs -
Publication type Publication time Location Refusal questions and answers (Q&A) 1 month after EC decision (document moved to medicine's EPAR page after EC decision)
Refusal public assessment report 2 months after CVMP opinion Medicines search: EPARs (on medicine page under 'Assessment history') -
After the EC decision, depending on the outcome of the re-examination, EMA publishes the same set of documents as for positive and negative opinions.
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Publication type Publication time Location Withdrawal letter Published together with Withdrawal European public assessment report (WEPAR) Medicines search: withdrawn applications Withdrawal public assessment report Within 3 months of receipt of withdrawal letter Medicines search: withdrawn applications Withdrawal statement Within 3 months of receipt of withdrawal letter Medicines search: withdrawn applications Withdrawal key facts Within 3 months of receipt of withdrawal letter Medicines search: withdrawn applications -
Publication type Publication time Location MRL summaries of opinion (pending EC decision) Friday following CVMP plenary European public maximum-residue-limit assessment report (EPMAR) Following publication of the respective MRL regulation by the European Commission
(within 4 weeks)MRL opinions Following publication of the respective MRL regulation by the European Commission
(within 4 weeks)
Changes to centralised marketing authorisations
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Positive opinions
Publication type Publication time Location Summary of opinion Friday following CVMP plenary - CVMP press release
- Medicines search: summaries of opinion (application type: post-authorisation; opinion status: positive)
(document moved to medicine's EPAR page after EC decision)
Update of EPAR documents, including:
- product information;
- procedural steps document;
- EPAR summary (if applicable);
- list of all authorised presentations (if applicable).
2 months after EC decision Public assessment report 2 motnhs after EC decision Medicines search: EPARs (on medicine page under 'Assessment history')
Negative opinions
Publication type Publication time Location Refusal summary of opinion Friday following CVMP plenary Update of procedural steps document 2 months after EC decision Medicines search: European public assessment reports (on medicine page under 'Assessment history')
Refusal public assessment report 2 months after EC decision Medicines search: European public assessment reports (on medicine page under 'Assessment history')
Re-examinationsAfter 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.
Withdrawal
Publication type Publication time Location Withdrawal letter Within 3 months of receipt of withdrawal letter Medicines search: withdrawn applications (application type: post-authorisation) (on medicine pages under 'All documents')
Withdrawal public assessment report Within 3 months of receipt of withdrawal letter Medicines search: withdrawn applications (application type: post-authorisation) (on medicine pages under 'All documents')
Withdrawal statement Within 3 months of receipt of withdrawal letter Medicines search: withdrawn applications (application type: post-authorisation) (on medicine pages under 'Overview') Withdrawal key facts Within 3 months of receipt of withdrawal letter Medicines search: withdrawn applications (application type: post-authorisation) (on medicine pages under 'key facts') Update of procedural steps document Within 3 months of receipt of withdrawal letter Medicines search: EPARs (on medicine page under 'Assessment history')
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Publication type Publication time Location Summary of opinion for:
- changes to contra-indications;
- changes that significantly alter the medicine's use.
Friday following CVMP plenary CVMP press release Update of EPAR documents, including:
- product information;
- procedural steps document;
- EPAR summary (if applicable);
- list of all authorised presentations (if applicable).
2 months after EC decision or within 2 months after CVMP opinion / notification, as applicable Public assessment reports
(for those changes that are of significant clinical relevance)2 months after EC decision or within 2 months after CVMP opinion / notification, as applicable Medicines search: EPARs (on medicine page under 'All documents')
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Publication type Publication time Location Public statement At time of withdrawal or expiry of marketing authorisation EPAR documents watermarked At time of withdrawal or expiry of marketing authorisation
Referrals
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Publication type Publication time Location Announcement of start of referral Friday following CVMP plenary at which referral started Announcement of end of referral assessment Friday following CVMP plenary where opinion is adopted Questions-and-answers document, summarising the subject and outcome of the referral procedure 4 weeks after EC decision Medicines search: Referrals (on medicine page under 'All documents')
List of the medicines affected by the referral (Annex I) 4 weeks after EC decision Medicines search: Referrals (on medicine page under 'All documents')
Scientific conclusions of the Committee (Annex II) 4 weeks after EC decision Medicines search: Referrals (on medicine page under 'All documents')
Changes to the product information (Annex III) 4 weeks after EC decision Medicines search: Referrals (on medicine page under 'All documents')
Conditions of the marketing authorisation(s) (Annex IV) 4 weeks after EC decision Medicines search: Referrals (on medicine page under 'All documents')
Other documents and procedures
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Publication type Publication time Location Limited market classifications Twice a year to be confirmed
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Publication type Publication time Location DaHPC At the time of dissemination of the DHPC
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Publication type Publication time Location Committees agendas Before start of Committee plenary Committees minutes After Committee plenary where minutes are adopted CHMP meeting highlights Friday following CHMP plenary CVMP press releases Friday following CVMP plenary CVMP monthly reports 2 months following CVMP plenary CVMP: Agendas, minutes and reports PRAC meeting highlights Friday following PRAC plenary CAT, COMP and PDCO monthly meeting reports Week following Committee plenary