Human medicines

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Guide to information published on human medicines

EMA's guide describes 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

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

Publication typePublication timeLocation
List of medicines that are under evaluationMonthlyMedicines under evaluation
COMP monthly meeting reports (for orphan medicines)Week following COMP plenaryCOMP: Agendas, minutes and meeting reports

Publication typePublication timeLocation
Summary of opinionFriday following CHMP plenary

(document moved to medicine 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.

2 weeks after EC decision

 

 

Medicines search: Medicines: Authorised
Communication on medication error prevention (if applicable)2 weeks after EC decisionRecommendations on medication errors
Orphan maintenance or withdrawal  assessment report (for orphan medicines)2 weeks after EC decisionMedicines search: Medicines: Authorised (on medicine page under 'Initial marketing authorisation documents')

 

Publication typePublication timeLocation
Refusal questions and answers (Q&A)Friday following CHMP plenary

(document moved to medicine page after EC decision)

Refusal public assessment report2 weeks after EC decisionMedicines search: Medicines: Opinion (on medicine page under 'Assessment history')

Publication typePublication timeLocation
Re-examination questions and answers (for positive and negative outcomes)

Friday following CHMP plenary

 

(document moved to medicine 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.

Publication typePublication timeLocation
Withdrawal questions and answersFriday following upcoming CHMP plenary
Withdrawal letterFriday following upcoming CHMP plenaryMedicines search: withdrawn applications
Withdrawal public assessment reportWithin 3 months of receipt of withdrawal letterMedicines search: withdrawn applications

Changes to centralised marketing authorisations

Positive opinions
 

Publication typePublication timeLocation
Summary of opinionFriday following CHMP plenary

(document moved to medicine 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 (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 report2 weeks after EC decision

Medicines search: Medicines: Authorised (on medicine page under 'Assessment history')

Negative opinions
 

Publication typePublication timeLocation
Refusal Q&AFriday following CHMP plenary

(document moved to medicine page after EC decision)

Update of procedural steps document4–5 weeks after CHMP opinion

Medicines search: Medicines: Authorised (on medicine page under 'Assessment history')

Refusal public assessment report4–5 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 typePublication timeLocation
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 typePublication timeLocation
Withdrawal Q&AFriday following CHMP plenary

Medicines search: Post-authorisation procedures for medicines: Withdrawn applications

Withdrawal letterFriday following CHMP plenary

Medicines search: Post-authorisation procedures for medicines: Withdrawn applications  (on medicine pages under 'Documents')

Withdrawal public assessment reportWithin 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 documentWithin 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 typePublication timeLocation
Q&A for change in scopeFriday following CHMP plenary

Medicines search: Medicines: Authorised

Update of procedural steps document2 weeks after EC decision

Medicines search: Medicines: Authorised (on medicine page under 'Assessment history')

Updated product information2 weeks after EC decision

Medicines search: Medicines: Authorised (on medicine page under 'Product information')

Public assessment report2 weeks after EC decision

Medicines search: Medicines: Authorised (on medicine page under 'Assessment history')

 

Publication typePublication timeLocation

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 typePublication timeLocation
Public statementAt time of withdrawal or expiry of marketing authorisation

Medicines search: Medicines: Withdrawn

EPAR documents watermarkedAt time of withdrawal or expiry of marketing authorisation

Medicines search: Medicines: Withdrawn

 

Referrals

Publication typePublication timeLocation
Announcement of start of referralFriday 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 communicationFriday following CHMP or CMDh plenary where CHMP opinion or CMDh position is adopted
Text of the updated product information in EnglishFriday 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 positionFriday 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 report1 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')

Annexes4 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 typePublication timeLocation
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 documentFriday 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 adoptedMedicine search: Referrals: Article 13(2), 29(4) and 30 referrals (on medicine page under 'All documents')
Public assessment report1 week after EC decision

Medicine search: Referrals: Article 13(2), 29(4) and 30 referrals (on medicine page under 'All documents')

Annexes4 weeks after EC decision

Medicine search: Referrals: Article 13(2), 29(4) and 30 referrals (on medicine page under 'All documents')

Publication typePublication timeLocation
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 report15 days after CHMP opinion

Article 5(3) opinions

Publication typePublication timeLocation
Summary of CHMP conclusionsFriday following CHMP plenary where CHMP opinion is adoptedMedicine 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 typePublication timeLocation
Public summary of opinion on orphan designation4 weeks after EC decision on orphan designationMedicine search: Orphan designations
Orphan maintenance / withdrawal assessment report2 weeks after EC decision 

Medicine search: Orphan designations (on medicine page under 'Review of designation')

Orphan maintenance / withdrawal assessment report following Member State request6-8 weeks after COMP opinion

Medicine search: Orphan designations (on medicine page under 'Review of designation')

Publication typePublication timeLocation

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 typePublication timeLocation
Recommendations on eligibility to PRIME schemeAfter each CHMP meeting
List of products granted eligibility to PRIME After each CHMP meeting

 

Publication typePublication timeLocation
Decisions on PIPs and waivers6-8 weeks after EMA decision

Medicines search: Paediatric investigation plans

Compliance check outcomeTwice a yearMedicines search: Paediatric investigation plans
Compliance statement2 weeks after EC decision or 4-5 weeks after CHMP opinion / notification, as applicable

Medicines search: Paediatric investigation plans

Publication typePublication timeLocation
PRAC recommendations on signalsWithin 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 typePublication timeLocation
List of medicines under additional monitoringMonthly

List of medicines under additional monitoring

Publication typePublication timeLocation
Summary of compassionate useAfter 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

Public statement on end of compassionate use programmeFollowing notification from companyCompassionate use

Publication typePublication timeLocation
Ongoing medicine shortageAt time of shortage

Medicines search: Ongoing and resolved shortages

Resolved medicine shortageWhen shortage is resolvedMedicines search: Ongoing and resolved shortages

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

Publication typePublication timeLocation

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: 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 typePublication timeLocation
List of medicines Within 1 week or 2 months of conclusion of PSUSA
(for maintenance or variation, respectively)

Medicines search: PSUSAs

Scientific conclusions and grounds for variation to the terms of the marketing authorisations
(if applicable)
Within 2 months after conclusion of PSUSA

Medicines search: PSUSAs

Public assessment report
(for PSURs that are of significant clinical relevance)
Within 2 months after conclusion of PSUSA

Medicines search: PSUSAs

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 typePublication timeLocation
DHPCAt the time of dissemination of the DHPC

Medicines search: DHPCs

Publication typePublication timeLocation
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 typePublication timeLocation
Consultation public assessment report2 weeks after notified body confirms issue of CE mark

CHMP opinions on consultation procedures

Procedural steps and scientific information after initial consultation2 weeks after finalisation of a post-consultation procedure

CHMP opinions on consultation procedures

Publication typePublication timeLocation
Medical literature monitoring: substance and herbal substance groupsAnnually

Monitoring of medical literature and entry of adverse reaction reports into EudraVigilance

Publication typePublication timeLocation
Clinical reports for marketing authorisation applications, line extensions and extensions of indicationWithin 60 days after EC decision and following publication of the EPAR

Clinical data website

Clinical reports for medicines for use outside the EU (Article 58 applications)Within 150 days after the CHMP opinion

Clinical data website

Clinical reports for withdrawn applicationsWithin 150 days after the receipt of the withdrawal letter

Clinical data website

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 typePublication timeLocation
Summary of opinionFriday following CVMP plenary

(document moved to medicine 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: Medicines: Authorised

 

Publication typePublication timeLocation
Refusal questions and answers (Q&A)1 month after EC decision

(document moved to medicine page after EC decision)

Refusal public assessment report2 months after CVMP opinion 

Medicines search: Medicines: Authorised (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 typePublication timeLocation
Withdrawal letterPublished together with Withdrawal European public assessment report (WEPAR)Medicines search: Medicines: Withdrawn applications 
Withdrawal public assessment reportWithin 3 months of receipt of withdrawal letterMedicines search: Medicines: Withdrawn applications 
Withdrawal statementWithin 3 months of receipt of withdrawal letterMedicines search: Medicines: Withdrawn applications 
Withdrawal key factsWithin 3 months of receipt of withdrawal letterMedicines search: Medicines: Withdrawn applications 

Publication typePublication timeLocation
MRL summaries of opinion (pending EC decision)Friday following CVMP plenary

Medicine search: Opinions on MRLs

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

Medicines search: MRLs

MRL opinionsFollowing publication of the respective MRL regulation by the European Commission 
(within 4 weeks)

Maximum residue limit opinions

Changes to centralised marketing authorisations

Positive opinions
 

Publication typePublication timeLocation
Summary of opinionFriday following CVMP plenary

(document moved to medicine 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

Medicines search: Medicines: Authorised

Public assessment report2 motnhs after EC decision

Medicines search: Medicines: Authorised (on medicine page under 'Assessment history')

Negative opinions
 

Publication typePublication timeLocation
Refusal summary of opinionFriday following CVMP plenary
Update of procedural steps document2 months after EC decision

Medicines search: Medicines: Authorised (on medicine page under 'Assessment history')

Refusal public assessment report2 months after EC decision

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.

Withdrawal
 

Publication typePublication timeLocation
Withdrawal letterWithin 3 months of receipt of withdrawal letter

Medicines search: Post-authorisation procedures for medicines: Withdrawn applications (on medicine pages under 'All documents')

Withdrawal public assessment reportWithin 3 months of receipt of withdrawal letter

Medicines search: Post-authorisation procedures for medicines: Withdrawn applications (on medicine pages under 'All documents')

Withdrawal statementWithin 3 months of receipt of withdrawal letterMedicines search: Post-authorisation procedures for medicines: Withdrawn applications (on medicine pages under 'Overview')
Withdrawal key factsWithin 3 months of receipt of withdrawal letterMedicines search: Post-authorisation procedures for medicines: Withdrawn applications (on medicine pages under 'key facts')
Update of procedural steps documentWithin 3 months of receipt of withdrawal letter

Medicines search: Medicines: Authorised (on medicine page under 'Assessment history')

 

Publication typePublication timeLocation

Summary of opinion for:

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

Medicines search: Medicines: Authorised

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: Medicines: Authorised (on medicine page under 'All documents')

 

Publication typePublication timeLocation
Public statementAt time of withdrawal or expiry of marketing authorisation

Medicines search: Medicines: Withdrawn

EPAR documents watermarkedAt time of withdrawal or expiry of marketing authorisation

Medicines search: Medicines: Withdrawn

 

Referrals

Publication typePublication timeLocation
Announcement of start of referralFriday following  CVMP plenary at which referral  started

CVMP press release

Announcement of end of referral assessmentFriday following CVMP plenary where opinion is adopted

CVMP press release

Questions-and-answers document, summarising the subject and outcome of the referral procedure4 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

Publication typePublication timeLocation
Limited market classificationsTwice a year

CVMP recommendations on limited market classification and eligibility for authorisation under Article 23

Publication typePublication timeLocation
DaHPCAt the time of dissemination of the DHPC

Medicines search: DHPCs (categories: veterinary) 

Committee agendas and outcomes

Publication typePublication timeLocation
Committees agendasBefore start of Committee plenary
Committees minutesAfter Committee plenary where minutes are adopted
CHMP meeting highlightsFriday following CHMP plenary
CVMP press releasesFriday following CVMP plenary
CVMP monthly reports2 months following CVMP plenary
PRAC meeting highlightsFriday following PRAC plenary
CAT, COMP and PDCO monthly meeting reportsWeek following Committee plenary 

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