Search Search Medicines Human regulatory Veterinary regulatory Committees News & events Partners & networks About us Medicines Search Download What we publish and when Medicines under evaluation National registers EPARs: background and context What we publish on medicines and when Table of contents Human medicines Veterinary medicines Committee agendas and outcomes 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. Human medicines 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 Expand section Collapse section Medicines under initial evaluation Positive opinions Negative opinions Re-examinations of opinion Withdrawals of application Changes to centralised marketing authorisations Expand section Collapse section Extensions of indication Other variations, annual re-assessments, renewals and line extensions Withdrawals / expiry of authorisation Referrals Expand section Collapse section Article 20, 31 and 107i referrals Article 13(2), 29(4) and 30 referrals Article 5(3) opinions Article 29 (Paediatrics) opinions Other documents and procedures Expand section Collapse section Orphan designations Advanced therapy classifications Requests for PRIME eligibility Paediatric investigation plans (PIP) Safety signals Medicines under additional monitoring Compassionate use Medicine supply shortages Periodic safety update reports Imposed non-interventional post-authorisation safety studies (PASS) Direct healthcare professional communications (DHPC) Medicines for use outside the EU (Article 58) opinions Ancillary medicinal substances Medical literature monitoring Clinical data publication* Veterinary medicines Overview of publications and their location Applications for centralised marketing authorisation Expand section Collapse section Positive opinions Negative opinions Re-examinations of opinion Withdrawals of application Maximum residue limits (MRL) Changes to centralised marketing authorisations Expand section Collapse section Extensions of indication Other variations, annual re-assessments, renewals and line extensions Withdrawals / expiry of authorisation Referrals EU referrals Other documents and procedures Minor use / minor species (MUMS) / limited market classifications Committee agendas and outcomes Agendas, minutes and reports of meetings of EMA's scientific committees Related content Download medicine data Authorisation of medicines How EMA evaluates medicines for human use Medicine evaluation figures Related documents List item EMA medical terms simplifier (PDF/950.16 KB) First published: 19/03/2021 EMA/158473/2021 How useful was this page? Add your rating ★ ★ ★ ★ ★ Average ★ ★ ★ ★ ★ View all 20 ratings Product emergency hotline OUTSIDE WORKING HOURS ABOUT Who we are Human regulatory Veterinary regulatory Committees ASK EMA Send a question FAQs Access to documents LINKS Legal Privacy Complaints Contacts Glossary Search tips Business hours and holidays CONTACT European Medicines Agency Domenico Scarlattilaan 6 1083 HS Amsterdam The Netherlands Tel: +31 (0)88 781 6000 For delivery address, see: How to find us For the United Kingdom, as of 1 January 2021, European Union law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland / NI. RSS feed Twitter YouTube LinkedIn © 1995-2021 European Medicines Agency European Union agencies network An agency of the European Union