What we publish on medicines and when
The European Medicines Agency (EMA) publishes information on human medicines at various stages of their life cycle.
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Human medicines
Guide to information published on human medicines
This guide describes the different types of information EMA currently publishes for both centrally and non-centrally authorised medicines, as well as publication times and locations.
The main information is presented in a tabulated format further down, however full details about what we publish are available in the guide.
Guide to information on human medicines evaluated by EMA
Overview of publications and their location
Applications for centralised marketing authorisation
| Publication type | Publication time | Location |
|---|---|---|
| List of medicines that are under evaluation | Monthly | Medicines under evaluation |
| COMP monthly meeting reports (for orphan medicines) | Week following COMP plenary | COMP |
| Publication type | Publication time | Location |
|---|---|---|
| Summary of opinion | Friday following CHMP plenary |
|
| Dedicated press release (for selected medicines) | Friday following CHMP plenary | |
European public assessment report (EPAR) This includes:
| 2 weeks after EC decision
| Medicines search: Medicines: Authorised |
| 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: Medicines: Authorised (on medicine page under 'Initial marketing authorisation documents') |
| Publication type | Publication time | Location |
|---|---|---|
| Refusal questions and answers (Q&A) | Friday following CHMP plenary |
|
| Refusal public assessment report | 2 weeks after EC decision | Medicines search: Medicines: Opinion (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
|
|
| 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.
| Publication type | Publication time | Location |
|---|---|---|
| Withdrawal questions and answers | Friday following upcoming CHMP plenary1 | |
| Withdrawal letter | Friday following upcoming CHMP plenary1 | Medicines search: withdrawn applications |
| Withdrawal public assessment report | Within 3 months of receipt of withdrawal letter | Medicines search: withdrawn applications |
1 If a withdrawal letter is received during the CHMP plenary meeting, these documents will be published after the following plenary meeting.
Changes to centralised marketing authorisations
Positive opinions
| Publication type | Publication time | Location |
|---|---|---|
| Summary of opinion | Friday following CHMP plenary |
|
| Dedicated press release (for selected extensions of indication) | Friday following CHMP plenary | |
Update of EPAR documents, including:
| 2 weeks after EC decision | Medicines search: Medicines: Authorised |
| Orphan maintenance or withdrawal assessment report (if applicable) | 2 weeks after EC decision | Medicines search: Medicines: Authorised (on medicine page under 'Initial marketing authorisation documents') |
| Public assessment report | 2 weeks after EC decision | Medicines search: Medicines: Authorised (on medicine page under 'Assessment history') |
Negative opinions
| Publication type | Publication time | Location |
|---|---|---|
| Refusal Q&A | Friday following CHMP plenary |
|
| Update of procedural steps document | 4–5 weeks after CHMP opinion | Medicines search: Medicines: Authorised (on medicine page under 'Assessment history') |
| Refusal public assessment report | 4–5 weeks after CHMP opinion | Medicines search: Medicines: Authorised (on medicine page under 'Assessment history') |
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.
| Publication type | Publication time | Location |
|---|---|---|
| Re-examination Q&A (for both positive and negative outcomes) | Friday following CHMP plenary | (Q&A moved to medicine 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 upcoming CHMP plenary | Medicines search: Post-authorisation procedures for medicines: Withdrawn applications |
| Withdrawal letter | Friday following upcoming CHMP plenary | Medicines search: Post-authorisation procedures for medicines: Withdrawn applications (on medicine pages under 'Documents') |
| Withdrawal public assessment report | Within 3 months of receipt of withdrawal letter | Medicines search: Post-authorisation procedures for medicines: Withdrawn applications (on medicine pages under 'Documents') |
| Update of procedural steps document | Within 3 months of receipt of withdrawal letter | Medicines search: Medicines: Authorised (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 | Medicines search: Medicines: Authorised |
| Update of procedural steps document | 2 weeks after EC decision | Medicines search: Medicines: Authorised (on medicine page under 'Assessment history') |
| Updated product information | 2 weeks after EC decision | Medicines search: Medicines: Authorised (on medicine page under 'Product information') |
| Public assessment report | 2 weeks after EC decision | Medicines search: Medicines: Authorised (on medicine page under 'Assessment history') |
| Publication type | Publication time | Location |
|---|---|---|
Summary of opinion for:
| Friday following CHMP plenary | |
| Public health communication (for selected changes of major public health importance) | Friday following CHMP plenary | |
Update of EPAR documents, including:
| 2 weeks after EC decision or 4–5 weeks after CHMP opinion / notification, as applicable | Medicines search: Medicines: Authorised |
| 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: Medicines: Authorised (on medicine page under 'All documents') |
*EMA may also publish reports for negative or withdrawn applications if evaluation is of particular importance.
| 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
| Publication type | Publication time | Location |
|---|---|---|
| Announcement of start of referral | Friday following PRAC or CHMP plenary where referral is started | |
| Friday following PRAC or CHMP plenary where referral is started | Medicine search: Referrals: Referral 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: Referral type: Article 20, 31 and 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: Referral 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: Referral 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: Referral 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: Referral type: Article 20, 31 and 107i referrals (on medicine page under 'All documents') |
Update of EPAR documents if CAPs are involved, including:
| 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 |
|
| Friday following CHMP plenary where referral is started | Medicine search: Referrals: 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: 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: Article 13(2), 29(4) and 30 referrals (on medicine page under 'All documents') |
| Annexes | 4 weeks after EC decision | Medicine search: Referrals: Article 13(2), 29(4) and 30 referrals (on medicine page under 'All documents') |
| 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 |
| Publication type | Publication time | Location |
|---|---|---|
| Summary of CHMP conclusions | Friday following CHMP plenary where CHMP opinion is adopted | Medicine search: Referrals: Article 29 (Paediatrics) referrals |
| Public assessment report | 15 days after CHMP opinion | Medicine search: Referrals: Article 29 (Paediatrics) referrals (on medicine page under 'Documents') |
Other documents and procedures
| Publication type | Publication time | Location |
|---|---|---|
| Orphan designation page | 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') |
| Publication type | Publication time | Location |
|---|---|---|
Summary of scientific recommendations on classification of advanced-therapy medicinal products | After CAT conclusion | Summaries of scientific recommendations on classification of advanced therapy medicinal products |
| Publication type | Publication time | Location |
|---|---|---|
| Recommendations on eligibility to PRIME scheme | After each CHMP meeting | |
| List of products granted eligibility to PRIME | After each CHMP meeting |
|
| 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 | |
| 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: Ongoing and 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:
| 2 weeks after EC decision | Medicines search: Medicines: Authorised (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: Medicines: Authorised (on medicine page under 'Assessment history') |
| Public assessment report (for PSUSAs that are of significant clinical relevance) | 2 weeks after EC decision | Medicines search: Medicines: Authorised (on medicine page under 'Assessment history') |
PSUSAs for active substances in nationally authorised medicines only
| Publication 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.
| 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 | Medicines search: Opinions on medicines for use outside the European Union |
| 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 | Monitoring of medical literature and entry of adverse reaction reports into EudraVigilance |
| 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
Veterinary medicines
Overview of publications and their location
Applications for centralised marketing authorisation
| Publication type | Publication time | Location |
|---|---|---|
| Summary of opinion | Friday following CVMP plenary | (document moved to medicine page after EC decision) |
| Dedicated press release (for selected medicines) | Friday following CVMP plenary |
|
Product summary This includes:
| 2 weeks after EC decision | |
European public assessment report (EPAR) This includes:
| 6 weeks after EC decision | Veterinary Medicines Information website |
| Publication type | Publication time | Location |
|---|---|---|
| Refusal questions and answers (Q&A) | 1 month after EC decision | (document moved to medicine page after EC decision) |
| Refusal public assessment report | 6 weeks after EC decision | Medicines search: Medicines: Refused (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.
| Publication type | Publication time | Location |
|---|---|---|
| Withdrawal letter | Published together with Withdrawal European public assessment report (WEPAR) | Medicines search: Medicines: Application withdrawn |
| Withdrawal public assessment report | Within 3 months of receipt of withdrawal letter | Medicines search: Medicines: Application withdrawn |
| Withdrawal key facts | Within 3 months of receipt of withdrawal letter | Medicines search: Medicines: Application withdrawn |
| 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
| Publication type | Publication time | Location |
|---|---|---|
Summary of opinion for VRAs, if applicable:
| Friday following CVMP plenary | CVMP meeting highlights |
Update of EPAR documents, if applicable, that include:
| 2 months after EC decision or within 2 months after CVMP opinion/notification, as applicable | Veterinary Medicines information website |
| Publication type | Publication time | Location |
|---|---|---|
| Withdrawal public assessment report | Within 3 months of receipt of withdrawal letter | Medicines search: Post-authorisation procedures for medicines: Application withdrawn (on medicine pages under 'All documents') |
| Publication type | Publication time | Location |
|---|---|---|
| Public statement | At the time of withdrawal of marketing authorisation | Medicines search: Medicines: Withdrawn |
| EPAR documents watermarked | At the time of withdrawal of marketing authorisation | Veterinary Medicines information website |
Referrals
EU referrals
| Publication type | Publication time | Location |
|---|---|---|
Announcement of start of referral, including:
| Friday following CVMP plenary at which referral started | Medicines search: Referrals: Referral type: Article 82, 82 based on 129(3) referrals (on medicine page under 'All documents') |
| Updated communication: CVMP opinion | Friday following CVMP plenary where opinion is adopted |
|
| Annexes of CVMP opinion | 4 weeks after EC decision | Medicines search: Referrals: Referral type: Article 82, 82 based on 129(3) referrals (on medicine page under 'All documents') |
| Questions-and-answers document, summarising the subject and outcome of the referral procedure | 4 weeks after EC decision | Medicines search: Referrals: Referral type: Article 82, 82 based on 129(3) referrals (on medicine page under 'All documents') |
| Updated product information (for centrally authorised products only) | 2 weeks after EC decision | Veterinary Medicines information website |
| Publication type | Publication time | Location |
|---|---|---|
Announcement of start of procedure, including:
| Friday following CVMP plenary at which procedure started |
|
| Updated communication: CVMP opinion | Friday following CVMP plenary at which procedure started |
|
| Annexes of CVMP opinion | 4 weeks after EC decision | Medicines search: Referrals: Referral type: Article 130(4) (on referral page under 'All documents') |
| Questions-and-answers document, summarising the subject and outcome of the referral procedure | 4 weeks after EC decision | Medicines search: Referrals: Referral type: Article 130(4) (on referral page under 'All documents') |
Updated CAP documents, including:
| 2 weeks after EC decision | Veterinary Medicines information website |
| Publication type | Publication time | Location |
|---|---|---|
Announcement of start of referral, including:
| Friday following CVMP plenary at which referral started |
|
| Updated communication: CVMP opinion | Friday following CVMP plenary at which referral started |
|
| Annexes of CVMP opinion | 4 weeks after EC decision | Medicines search: Referrals: Referral type: Article 70(11) referral (on referral page under 'All documents') |
| Questions-and-answers document, summarising the subject and outcome of the procedure | 4 weeks after EC decision | Medicines search: Referrals: Referral type: Article 70(11) referral (on referral page under 'All documents') |
| Publication type | Publication time | Location |
|---|---|---|
| Announcement of start of procedure | Friday following CVMP plenary at which procedure started | |
| CVMP clarifications | Friday following CVMP plenary where clarifications are adopted |
| Publication type | Publication time | Location |
|---|---|---|
| Announcement of start of procedure | Friday following CVMP plenary at which procedure started | CVMP meeting highlights |
| Updated communication: CVMP opinion | Friday following CVMP plenary where opinion is adopted | CVMP meeting highlights |
| Scientific opinion | 15 days after CVMP opinion | Article 141(1) opinions |
Other documents and procedures
| Publication type | Publication time | Location |
|---|---|---|
| Recommendations on limited market classifications | Twice a year | CVMP recommendations on limited market classification and eligibility for authorisation under Article 23 |
| Publication type | Publication time | Location |
|---|---|---|
| DaHPC | At the time of dissemination of the DaHPC | Medicines search: DHPCs (categories: veterinary) |