What we publish on medicines and when

The European Medicines Agency (EMA) publishes information on human medicines at various stages of their life cycle
HumanVeterinaryHerbal

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
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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:

  • medicine overview;
  • product information;
  • list of all authorised presentations;
  • public assessment report;
  • risk management plan.

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:

  • product information;
  • procedural steps document;
  • medicine overview (if applicable);
  • list of all authorised presentations (if applicable);
  • updated risk management plan (if applicable).
 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:

  • 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 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

Medicines search: Medicines: Withdrawn
EPAR documents watermarked At time of withdrawal or expiry of marketing authorisation

Medicines search: Medicines: Withdrawn

 

Referrals

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: 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:

  • product information;
  • procedural steps document;
  • medicine overview and list of all authorised presentations(if applicable)
     
2 weeks after EC decision

Medicines search: Medicines: Authorised

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: 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

Article 5(3) opinions

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

Available via sitewide search:

Orphan designations
Orphan maintenance / withdrawal assessment report 2 weeks after EC decision 

Available via sitewide search:

Orphan designations (under Documents related to this orphan designation evaluation page section)

Medicines: Authorised (under Assessment history page section)
Orphan maintenance / withdrawal assessment report following Member State request 6-8 weeks after COMP opinion

Available via sitewide search:

Orphan designations (under Documents related to this orphan designation evaluation page section)

Medicines: Authorised (under Assessment history page section)

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

PRIME: priority medicines

Available via sitewide search:

CHMP meeting highlights
List of products granted eligibility to PRIME  After each CHMP meeting

PRIME: priority medicines

 

Publication type Publication time Location
Decisions on PIPs and waivers 6-8 weeks after EMA decision

Available via sitewide search:

Paediatric investigation plans
Compliance check outcome Twice a year

Available via sitewide search:

Paediatric investigation plans
Compliance statement 2 weeks after EC decision or 4-5 weeks after CHMP opinion / notification, as applicable

Available via sitewide search:

Paediatric investigation plans

Publication type Publication time Location
PRAC recommendations on signals Within a month of PRAC plenary PRAC recommendations on safety signals
New product information wording (if applicable) Within a month of PRAC plenary PRAC recommendations on safety signals

Publication type Publication time Location
List of medicines under additional monitoring Monthly List of medicines under additional monitoring

Publication type Publication time Location
Summary of compassionate use After CHMP opinion Compassionate use
  • Conditions of use
  • Conditions for distribution
  • Patients targeted
  • Conditions for safety monitoring
 After CHMP opinion Compassionate use
Dedicated press release (for selected opinions) Friday following CHMP plenary

Homepage

Available via sitewide search

CHMP meeting highlights
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

Available via sitewide search:

Supply shortages (filter by Shortage status)
Resolved or ceased medicine shortage When shortage is resolved or ceased

Periodic safety update report single assessments (PSUSAs) for active substances in centrally authorised medicines only

Publication type Publication time Location

Update of medicine documents, including:

  • product information;
  • procedural steps document
  • overview (if applicable)
  • list of all authorised presentations (if applicable)
 2 weeks after EC decision

Available via sitewide search:

Medicine: Authorised
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

Available via sitewide search:

Medicine: Authorised (under Assessment history page section)
Public assessment report
(for PSUSAs that are of significant clinical relevance)		 2 weeks after EC decision

Available via sitewide search:

Medicine: Authorised (under Assessment history page section)

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)

Available via sitewide search:

Periodic safety update report single assessments (PSUSA)
Scientific conclusions and grounds for variation to the terms of the marketing authorisations
(if applicable)		 Within 2 months after conclusion of PSUSA

Available via sitewide search:

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

Available via sitewide search:

Periodic safety update report single assessments (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 medicine 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

Available via sitewide search:

Direct healthcare professional communication (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

Available via sitewide search:

Opinions on medicines for use outside EU

Publication type Publication time Location
Consultation public assessment report 2 weeks after notified body confirms issue of CE mark CHMP opinions on consultation procedures on ancillary substances incorporated in a medical device
Procedural steps and scientific information after initial consultation 2 weeks after finalisation of a post-consultation procedure CHMP opinions on consultation procedures on ancillary substances incorporated in a medical device

Publication type Publication time Location
Medical literature monitoring: substance and herbal substance groups Annually Medical literature monitoring

Veterinary applications for centralised marketing authorisation

Publication type Publication time Location
Summary of opinion Friday following CVMP plenary

Available via sitewide search:

  • CVMP meeting highlights
  • Medicines: Opinion
Dedicated news (for selected medicines) Friday following CVMP plenary

Homepage

Available via sitewide search:

CVMP meeting highlights

Medicine

This includes:

  • summary of opinion
  • public assessment report
 2 weeks after EC decision

Available via sitewide search:

Medicines: Authorised

Medicine

This includes:

  • authorisation details;
  • product information;
  • public assessment reports.
 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

Available via sitewide search:

  • CVMP meeting highlights
  • Medicines: Opinion
Refusal public assessment report 6 weeks after EC decision

Available via sitewide search:

  • CVMP meeting highlights
  • Medicines: Opinion

 

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)

Available via sitewide search:

Medicine: application withdrawn
Withdrawal public assessment report Within 3 months of receipt of withdrawal letter

Available via sitewide search:

Medicine: application withdrawn
Withdrawal key facts Within 3 months of receipt of withdrawal letter

Available via sitewide search:

Medicine: application withdrawn

Publication type Publication time Location
MRL summaries of opinion (pending EC decision) Friday following CVMP plenary

Available via sitewide search:

Maximum residue limits
European public maximum-residue-limit assessment report (EPMAR) Following publication of the respective MRL regulation by the European Commission
(within 4 weeks)

Available via sitewide search:

Maximum residue limits
MRL opinions Following publication of the respective MRL regulation by the European Commission 
(within 4 weeks)

Available via sitewide search:

Maximum residue limits

Veterinary changes to centralised marketing authorisations

Publication type Publication time Location

Summary of opinion for VRAs, if applicable:

  • changes to contra-indications;
  • changes that significantly alter the medicine's use.
 Friday following CVMP plenary

Available via sitewide search:

CVMP meeting highlights

Update of medicine documents, if applicable, that include:

  • product information;
  • public assessment report (for those changes that are of significant clinical relevance).
 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 letter Published together with Withdrawal European public assessment report (WEPAR)

Available via sitewide search:

Post-authorisation procedures for medicines: Application withdrawn
Withdrawal public assessment report Within 3 months of receipt of withdrawal letter

Available via sitewide search:

Post-authorisation procedures for medicines: Application withdrawn
Withdrawal key facts Within 3 months of receipt of withdrawal letter

Available via sitewide search:

Post-authorisation procedures for medicines: Application withdrawn

 

Publication type Publication time Location
Update to the medicine Overview section At the time of withdrawal of marketing authorisation

Available via sitewide search:

Medicines: Withdrawn
Medicine documents watermarked At the time of withdrawal of marketing authorisation

Available via sitewide search:

Medicines: Withdrawn

 

Veterinary referrals

Publication type Publication time Location

Announcement of start of referral, including:

  • notification;
  • draft list of medicines;
  • list of questions;
  • timetable;
  • list of questions addressed to stakeholders;
  • stakeholders form.
 Friday following CVMP plenary at which referral started

Available via sitewide search:

  • Referrals (filter by Referral type) (under All documents page section)
Updated communication: CVMP opinion Friday following CVMP plenary where opinion is adopted
  • Available via sitewide search:
  • CVMP meeting highlights
  • Referrals (filter by Referral type)  (under All documents page section)
Annexes of CVMP opinion 4 weeks after EC decision

Available via sitewide search:

  • Referrals (filter by Referral type) (under All documents page section)
Questions-and-answers document, summarising the subject and outcome of the referral procedure 4 weeks after EC decision

Available via sitewide search:

  • Referrals (filter by Referral type) (under All documents page section)
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:

  • notification;
  • draft list of medicines;
  • list of questions.
 Friday following CVMP plenary at which procedure started

Available via sitewide search:

  • CVMP meeting highlights
  • Referrals (filter by Referral type) ( under All documents page section)
Updated communication: CVMP opinion Friday following CVMP plenary at which procedure started

Available via sitewide search:

  • CVMP meeting highlights
  • Referrals (filter by Referral type) ( under All documents page section)
Annexes of CVMP opinion 4 weeks after EC decision

Available via sitewide search:

Referrals (filter by Referral type) ( under All documents page section)
Questions-and-answers document, summarising the subject and outcome of the referral procedure 4 weeks after EC decision

Available via sitewide search:

Referrals (filter by Referral type) ( under All documents page section)

Updated CAP documents, including:

  • product information;
  • medicine overview and list of all authorised presentations (if applicable).
 2 weeks after EC decision Veterinary Medicines information website

Publication type Publication time Location

Announcement of start of referral, including:

  • notification;
  • draft list of medicines;
  • list of questions;
  • timetable.
 Friday following CVMP plenary at which referral started

Available via sitewide search:

  • CVMP meeting highlights
  • Referrals (filter by Referral type)  (under All documents page section)
Updated communication: CVMP opinion Friday following CVMP plenary at which referral started

Available via sitewide search:

  • CVMP meeting highlights
  • Referrals (filter by Referral type)  (under All documents page section)
Annexes of CVMP opinion 4 weeks after EC decision

Available via sitewide search:

Referrals (filter by Referral type)  (under All documents page section)
Questions-and-answers document, summarising the subject and outcome of the procedure 4 weeks after EC decision

Available via sitewide search:

Referrals (filter by Referral type)  (under All documents page section)

Publication type Publication time Location
Announcement of start of procedure  Friday following CVMP plenary at which procedure started

Available via sitewide search:

CVMP meeting highlights 
CVMP clarifications Friday following CVMP plenary where clarifications are adopted

Available via sitewide search:

  • CVMP meeting highlights 

Publication type Publication time Location
Announcement of start of procedure  Friday following CVMP plenary at which procedure started

Available via sitewide search:

CVMP meeting highlights
Updated communication: CVMP opinion Friday following CVMP plenary where opinion is adopted

Available via sitewide search:

CVMP meeting highlights
Scientific opinion 15 days after CVMP opinion Article 141(1) opinions on any scientific matter: veterinary medicines

Veterinary 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

Available via sitewide search:

Direct healthcare professional communication

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