Introduction How are medicines authorised in Europe? What information about medicines does the European Medicines Agency provide? Centrally authorised medicines Safety of medicines Medicines for rare diseases Herbal medicines Medicines for children Medicines in Community referral procedures Medicines for use outside the European Union Withdrawn, suspended or revoked authorisations Withdrawn applications Press releases Participation of patients and consumers in the European Medicines Agency activities Involve YOUR organisation Eligible organisations Patients' and Consumers' Working Party (PCWP)

 

Patients

Working with patients and consumers

Centrally authorised medicines

Centrally authorised medicines only
Please note that the information in this section relates only to medicines that have been authorised through the centralised (or 'Community') authorisation procedure. Information about medicines authorised in accordance with the national procedures of individual European countries can usually be found through the websites of the national regulatory authorities in those countries. The Heads of Agencies website is a useful entry point for such information.

Summaries of European Medicines Agency scientific evaluations

On the day that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopts a positive opinion concerning an application for a new medicine, a summary of the CHMP's scientific evaluation — called a 'summary of opinion' — is published.

The summary of opinion gives the name of the company developing the medicine, the medicine's active substance, its clinical benefits, any safety concerns relating to the medicine, and a brief statement of the reasons why the CHMP adopted a positive opinion in respect of the application for marketing authorisation.

The summary of opinion is replaced by a full European public assessment report (see below) once the European Commission has decided, taking the Agency's opinion into consideration, to grant a marketing authorisation.

Follow this link for published summaries of CHMP opinions

Conditional approval

Sometimes, the CHMP recommends that a medicine be given ‘conditional approval’. This happens when the Committee has based its positive opinion on data which, while not yet comprehensive, indicate that the medicine’s benefits outweigh its risks.

The company is given obligations to fulfil, such as the performance of further studies. The approval is renewed on a yearly basis until all obligations have been fulfilled, and is then converted from a conditional approval into a normal approval. Conditional approvals can only be granted for medicines that satisfy an ‘unmet medical need’, meaning the medicine is intended to be used for a disease or condition for which no treatment is readily available, and it is therefore important that patients have early access to the medicine concerned.

Medicines that have been granted conditional approval are identified on this website with the symbol Conditional approval.

Exceptional circumstances

Sometimes, the CHMP recommends that a medicine be approved under ‘exceptional circumstances’. This happens when the applicant can show that they are unable to provide comprehensive data on the efficacy and safety of the medicine for which authorisation is being sought, due to the rarity of the condition it is intended for, limited scientific knowledge in the area concerned, or ethical considerations involved in the collection of such data.

In such cases, the applicant is given obligations to fulfil, relating in particular to the safety of the medicine concerned. These are re-assessed every year until such time as the approval can be converted into a normal one.

Medicines authorised under exceptional circumstances are identified on this website with the symbol Exceptional circumstances.

European public assessment reports (EPARs)

Once a medicine has been granted a Community marketing authorisation by the European Commission, the European Medicines Agency publishes a full scientific assessment report — called a 'European public assessment report' (EPAR) — for that product on this website.

The EPAR provides detailed information about the scientific discussion and the procedural steps that led to the European Medicines Agency adopting a positive opinion in respect of that medicine. It also provides comprehensive information on how, when and why the medicine should (and should not) be used, and stipulates the information that must be included on the packaging and patient-information leaflet supplied with the medicine.

Initiative to provide clearer text for patients and consumers
In 2006, the Agency began publishing a 'Summary for the public' as part of every new EPAR. This sets out the most important information about the medicine in language that is clear and understandable to the general public. Summaries are also currently being prepared for all EPARs published before 2006.

Particular types of medicines that can be authorised include generic medicines and 'biosimilar' medicines. For more information what these medicines are and how they are authorised, follow this link.

Follow this link for published EPARs for medicines for human use

Information on refusals and withdrawals of marketing-authorisation applications

The European Medicines Agency also publishes information whenever the CHMP recommends that a medicine be refused a marketing authorisation (i.e. the Committee adopts a negative opinion on authorisation).

The refusal is announced at the time of the opinion, through publication of a question-and-answer document summarising the reason for the refusal. Later on, a full scientific assessment report is also published.

Follow this link for information on medicines that have been refused a marketing authorisation

Applicants sometimes withdraw their application before the end of the assessment procedure. When this happens, the European Medicines Agency immediately announces the withdrawal, and publishes a question-and-answer document summarising the state of the CHMP’s review at the time of the withdrawal. A full scientific report is published later on, unless the applicant’s withdrawal occurs before the CHMP has had time to complete its first review.

Follow this link for information on applications that have been withdrawn