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Frequently asked questions

The European Medicines Agency (EMA) answers frequently asked questions (FAQs) about its work and scope.
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You can find these FAQs in English, but it is also possible to download translations in all European Union languages. For that, you can check the section 'Translations of this webpage' at the bottom of the page and select your preferred language.

If the information you're looking for is not here, please send a question to EMA.

If you're a journalist or other media representative EMA invites you to contact the Agency's press office.

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The European Medicines Agency

EMA's main responsibility is the protection and promotion of public and animal health, by carrying out scientific evaluations of medicines for human and veterinary use.

The outcome of EMA's evaluation is used by the European Commission to decide whether a medicine can be authorised for marketing in the European Union (EU). The company producing a medicine can only market it once the medicine has received a marketing authorisation from the European Commission.

EMA also supervises the safetyof medicines in the EU after they have been authorised. It can also give scientific opinions on medicines at the request of Member States or the European Commission.

For more information:

EMA does not control:

  • the pricing of medicines;
  • patents on medicines;
  • the availability of medicines;
  • medical devices. However, EMA is involved in the assessment of certain categories of medical devices;
  • homeopathic medicines;
  • herbal supplements;
  • food supplements;
  • cosmetics.

For more information:

No. In the European Union (EU), there are two ways of getting a marketing authorisation for a medicine:

  • the centralised procedure, via EMA, which results in a single marketing authorisation valid throughout the EU;
  • national authorisation procedures, where individual EU Member States authorise medicines for use in their own territory.

There are also two routes to allow companies to gain authorisation in more than one country: the mutual-recognition procedure and the decentralised procedure.

For more information:

No. EMA will never ask citizens for payment of any sort.

If you receive an invoice using credentials such as EMA's name, emails, logo or names of EMA staff, you may be the target of an attempted scam.

Do not respond to such interactions - emails, phone calls or any other form of interaction.

Furthermore, consider reporting such cases to your national authorities competent for crimes and / or cybercrime.

For more information, see:

EMA's normal business hours are Monday to Friday, 08:30 to 18:00(Central European Time, CET).

EMA is closed for holidays on various days throughout the year. These are not always on the same days as the national holidays in the Netherlands or other Member States.

For more information:

No. EMA does not directly fund research.

No. EMA is unable to recommend academic courses in regulatory affairs, medicine, or any other discipline.

No. EMA is unable to supply pens, mugs or other items branded with EMA's logo.

Languages

Currently, most of the information on this website is only available in English. Much of this content provides regulatory guidance to the pharmaceutical industry, which mainly operates in English.

Information intended for a wider audience is translated into all official European Union (EU) languages.

For medicines evaluated by EMA, the following resources are available in all EU languages:

This website also provides core institutional information in official EU languages, such as these frequently asked questions (FAQs) and the 'About us' section.

Citizens can submit questions to EMA in any official EU language. EMA will reply in the same language.

For more information:

You can identify the documents that are translated into all official European Union(EU) languages through the box below: 

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This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.

COVID-19

You can find information on COVID-19 medicines on:

EMA publishes information in lay-language about the most important topics related to COVID-19 here:

You can find information translated to all EU languages on the respective medicine pages.

You can find more information on EMA's role in monitoring the safety of COVID-19 vaccines on the dedicated webpage:

You can also find information on the safety of COVID-19 vaccines on their respective medicine pages.

There's a description of the authorisation process for COVID-19 vaccines and treatments on these pages:

Medicines and their evaluation

EMA publishes information about all the medicines it assesses, irrespective of the outcome, as a European public assessment report (EPAR). This is a set of documents that explains the scientific conclusion reached by EMA's Committees at the end of the evaluation process. Each EPAR includes an overview for the public and the product information.

You can also find information on medicines at various stages of their life cycles, including the early developmental stages through to post-authorisation changes, safety reviews and suspensions and withdrawals of authorisation.

For more information:

EMA publishes a refusal EPAR together with a questions-and-answers (Q&A) document in the case of a negative recommendation, to explain the reasons for the refusal.

The medicine you are looking for may be:

  • authorised through national procedures and not centrally through EMA. To find information on nationally authorised medicines, contact the medicines regulatory agency in your country;
  • still in development and not yet authorised;
  • not classified as a medicine but as a medical device or a nutritional supplement.

For more information:

EMA publishes the names of the active substances of medicines currently under evaluation but cannot say when the medicines will be authorised. EMA takes around a year to evaluate a medicine, at the end of which it issues a recommendation on whether the medicine should be authorised. EMA then sends this recommendation to the European Commission, which takes a binding decision on whether to grant a marketing authorisation.

Following a positive recommendation from EMA, the European Commission takes around two months to authorise a medicine. The European Commission follows the opinion of EMA in almost all cases.

EMA publishes information on the medicines it evaluates at the time it makes a recommendation as well as after the European Commission has issued a marketing authorisation.

During the evaluation procedure, EMA publishes information relevant to the evaluation timetable in the agenda and minutes of the meetings of its relevant scientific committees.

For more information:

For the Committee for Medicinal Products for Human Use (CHMP) and the Pharmacovigilance Risk Assessment Committee (PRAC), EMA publishes meeting highlights with evaluation outcomes of major public interest on the Friday following their monthly plenary meetings. These are also published on EMA's homepage.

For the Committee for Advanced Therapies, the Committee (CAT) for Orphan Medicinal Products (COMP) and the Paediatric Committee (PDCO), EMA publishes monthly meeting reports in the week following the committee's plenary meeting. These documents can be found on the webpages of the respective committees.

To stay up to date with the latest news, features, and publications from EMA, you can subscribe to our RSS feeds or follow EMA on Twitter.

EMA also publishes a monthly newsletter called 'human medicines highlights', which provides key information on EMA's recent activities on human medicines.

For more information:

Availability of medicines

Medicines cannot be placed on the market without authorisation. However, some medicines can be supplied to individual patients under special conditions before they have been authorised. These include clinical trials and compassionate-use programmes, which Member States regulate.

To find out if a medicine is currently available in your country through a compassionate-use programme, check with your national medicines regulatory authority or the company responsible for the medicine.

In addition you may be eligible to take part in a clinical trial. For information on clinical trials, talk to your doctor or nurse.

For more information:

Although medicines evaluated by EMA receive an authorisation valid in the whole of the EU, decisions on where a medicine is marketed are made by the company that markets the medicine (the marketing-authorisation holder). EMA has no control over these decisions. This means that medicines that have received a central marketing authorisation via EMA may not be available in all European Union (EU) Member States.

A medicine that is authorised in the EU might not be authorised or marketed in countries outside the EU. Contact the medicines regulatory authorities in these countries to get more information on the availability of medicines in their territories.

For more information:

In the European Union (EU), companies can submit a marketing authorisation application (MAA) through the centralised procedure or via the national procedure.

The European Medicines Agency (EMA) evaluates centralised applications for medicines intended for EU-wide marketing. It then presents its opinion to the European Commission (EC), which decides whether to grant or refuse authorisation.

If the EC grants marketing authorisation, the medicine can be sold in any EU country without further national approval. The centralised procedure is mandatory for certain medicines and optional for others.

If the EC refuses an application, the company may submit a new one. They can either apply to the EMA again or, if the centralised procedure is optional, apply to a national competent authority.

If a national authority grants authorisation after evaluating the new submission, the medicine can be marketed in that country. This can be done even if EMA recommended refusing the initial application.

For information on national competent authorities, see: 

No. EMA does not have up-to-date information on the availability of medicines in Member States. Medicines regulatory authorities in Member States may be able to provide you with this information.

For more information:

No. EMA does not have any commercial interests and does not get involved in the distribution of medicines. EMA's responsibilities are limited to theevaluation of medicines for authorisation purposes and their supervision once they are authorised.

EMA is also unable to give any financial assistance to patients who are trying to get hold of a medicine.

EMA suggests that you discuss your treatment with a healthcare professional, such as a doctor or pharmacist.

For more information:

Reporting suspected side effects

If you are experiencing a side effect or think you may be experiencing one, you should seek advicefrom a doctor or pharmacist. You can also find information on side effects seen with a medicine in the package leaflet.

EMA also recommends that you report any suspected side effects to the national competent authority. You can do this either by talking to a healthcare professional, or in some cases, you can report the side effects directly to the national competent authority using online patient reporting forms or by telephone. For information on how to report a side effect in your country, pleaseconsult the appropriate authority.

These spontaneous reports of suspected side effects by healthcare professionals, patients or carers are used to continuously monitor the safety of medicines on the market and to ensure that their benefits continue to outweigh their risks.

EMA cannot accept side effect reports directly from patients. EMA is also not in a position to provide medical advice or to confirm whether your symptoms are being caused by your medicine.

For more information:

Medical advice

No. EMA cannot advise individual patients on their treatment or condition. EMA suggests that you discuss these issues with a healthcare professional, such as your doctor or pharmacist.

No. EMA does not maintain a list of medical specialists and is unable to adviseindividual patients on where to seek treatment.

Clinical trials

EMA is not involved in recruiting volunteers for clinical trials. If you would like to take part in a clinical trial, you should discuss it with your doctor or nurse, who may be able to refer you for a suitable trial.

For more information:

Medical devices

EMA has distinct regulatory roles per category of medical device, including in vitro diagnostics.

  • Medicines used in combination with a medical device
  • Medical devices with an ancillary medicinal substance
  • Companion diagnostics ('in vitro diagnostics')
  • Medical devices made of substances that are systemically absorbed
  • High-risk medical devices ? EMA supports the medical device expert panels that provide opinions and views to notified bodies on the scientific assessment of certain high-risk medical devices and in vitro diagnostics.

For more information:

EMA has a central role in monitoring and mitigating shortages of critical medical devices and in vitro diagnostics in the context of a public health emergency. 

For more information:

Herbal medicines

In the European Union (EU), herbal medicines are authorised by medicines regulatory authorities in Member States.

EMA has a role in preparing scientific opinions on the quality, safety, and efficacy of herbal medicines, to help harmonise this information across the EU. These 'Community herbal monographs' are prepared by the Committee on Herbal Medicinal Products (HMPC) and contain information about what a herbal medicine is used for, restrictions on its use, its undesirable effects and its interactions with other medicines.

For more information:

Food supplements and cosmetics

Food supplements are evaluated at national level, usually by the authorities that deal with food safety and labelling. They are not usually evaluated by medicines regulatory authorities, unless they contain a substance that has pharmacological activity or make a medicinal claim.

For more information:

Cosmetics are evaluated by authorities in each Member State. They are not evaluated by EMA.

For more information:

EMA fees

EMA charges fees to pharmaceutical companies for the services it provides. EMA publishes the rules on these fees, including a list of the fees charged for each type of procedure. Fees are adjusted each year for inflation.

For more information:

Transparency and competing interests

Most of the members of EMA's scientific committees are nominated by the Member States or the European Commission. EMA's Management Board is also made up of representatives of Member States and members nominated by the European Commission.

For more information:

The members of EMA's Management Board and scientific committees, and its experts and staff are not permitted to have financial or other interests in the pharmaceutical industry that could affect their impartiality. Each member and expert make an annual declaration of their financial interests. These are publicly available.

For more information:

EMA requires every patient and consumer organisation that it works with to provide financial statements, including details on donors and their contributions. Each organisation is re-evaluated every two years.

For more information:

Pricing, advertising, sales and patents

No. Decisions on pricing and reimbursement are made at a national level following negotiations between governments and marketing authorisation holders. EMA is not involved in these decisions and does not have any information on pricing or reimbursement arrangements in Member States.

For more information:

No. Advertising of medicines is controlled bymedicines regulatory authorities in Member States and other national regulatory bodies, together with self-regulation by the pharmaceutical industry.

In the European Union (EU), advertising of prescription-only medicines directly to patients and consumers is forbidden.

For more information:

EMA does not have information on sales figures or prescription numbers for any medicine. Sales are dealt with at a national level. The medicines regulatory authorities in Member States may be able to provide information on sales of a medicine.

For more information:

No. EMA is not responsible for patents on medicines: issues regarding patent law are not within EMA's remit. The European Patent Office may be able to provide information on a specific patent.

This website

A general 'Site-wide search' bar is featured at the top right of every page on the EMA website. It allows you to perform a full text search across web pages and documents on the EMA website.

A medicines 'Quick search' bar is featured on the homepage under 'Search for medicines'. If you are looking for information on a specific medicine assessed by EMA, you can use this feature to search our full database of human medicines, veterinary medicines, and herbal medicines.  

The main medicines search provides more options. It may be useful if you are looking for medicines for a particular disease area or therapeutic indication or if you are looking for specific types of medicines such as generics, biosimilars or orphan medicines.

Only medicines evaluated by EMA are available on the website. Information on medicines authorised in individual Member States through national procedures can only be obtained through the national medicines regulatory authorities. You may not be able to obtain a complete list of available treatment options for a specific condition by searching on EMA's website.

The search is currently only available in English. For more help with using the search functionalities, check our Search tips.

If your experience issues with this website, such as opening a link or a document, send us a message.

You can also rate a page and leave a comment under the section 'How useful was this page?' at the bottom of most pages of this website.

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