This page provides answers to the most frequently asked questions (FAQs) received by the European Medicines Agency. If the answer to your question is not here, please use this form to send a question to the Agency.
Journalists and other representatives of the press should contact our press office directly at firstname.lastname@example.org.
For FAQs in other European Union languages see frequently asked questions: Translations
Table of contents
- Questions about the Agency
- Questions about this website
- Questions about medicines
- Questions about the evaluation of other substances
- Questions about conflicts of interest and transparency
- Questions about the availability of medicines
- Questions about pricing, advertising, sales and patents
- Questions about medical advice
- Questions about clinical trials
- Questions about fees
Questions about the Agency
- What does the Agency do?
The Agency'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 the Agency'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.
The Agency also supervises the safety of 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.
More information: What we do
- What does the Agency not control?
The European Medicines Agency does not control:
- the pricing of medicines;
- patents on medicines;
- the availability of medicines;
- medical devices;
- homoeopathic medicines;
- herbal supplements;
- food supplements;
- advertising of medicines.
More information: What we do
- Are all medicines approved via the Agency?
No. In the European Union (EU), there are two ways of getting a marketing authorisation for a medicine:
- the centralised procedure, via the Agency, 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.
More information: Authorisation of medicines
- How are herbal medicines evaluated?
In the European Union (EU), herbal medicines are authorised by medicines regulatory authorities in Member States.
The Agency 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.
- What acronym should I use for the Agency?
If you wish to use an acronym for the Agency, use 'EMA'. Please note that this is an unofficial acronym.
The Agency's old acronym of 'EMEA' should not be used any longer.
- When is the Agency open?
The Agency's normal business hours are 9.00am to 5.30pm, Monday to Friday.
The Agency is closed for holidays on various days throughout the year. These are not always on the same days as the national holidays in the United Kingdom or other Member States.
More information: Business hours and holidays
- Can the Agency help to fund my work?
The EMA does not directly fund research. If you are looking for information on research funding opportunities in the field of medicine, you may be interested in:
- Can the Agency recommend academic courses?
No, the Agency is unable to recommend academic courses in regulatory affairs, medicine or any other discipline.
- Can the Agency supply me with branded merchandise?
No, the Agency is unable to supply pens, mugs or other items branded with the Agency's logo.
Questions about this website
- Is the Agency's website available in languages other than English?
Currently, most of the information on the Agency's website is only available in English. Some content is translated into other official European Union (EU) languages, including public summaries and product information in European public assessment reports (EPARs), question-and-answer documents for the public, information on recruitment, work programmes and summaries of the annual report. These frequently asked questions are also available in all EU languages.
Citizens can submit questions to the Agency in any official EU language. The Agency will reply in the same language.
More information: EPARs: human medicines - EPARs: veterinary medicines - Applying to work at the European Medicines Agency - Annual reports and work programmes - Frequently asked questions: Translations
Questions about medicines
- What type of information is available on a medicine evaluated by the Agency?
The Agency publishes information about all the medicines it assesses as a European public assessment report (EPAR). This is a set of documents that explains the scientific conclusion reached by the Agency's Committees at the end of the evaluation process. Each EPAR includes a summary for the public.
- How can I search for a medicine on the Agency's website?
You can search for a medicine by:
- browsing the A-to-Z list of human or veterinary medicines evaluated by the Agency;
- searching by keyword;
- browsing by therapeutic area or type of medicine.
You can also enter the name of the medicine under 'search for medicines' on the website's homepage.
Only medicines evaluated by the Agency 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. This means that you may not be able to obtain a complete list of available treatment options for a specific condition by searching on the Agency's website.
- Why can I not find information about a particular medicine on your website?
There are two main reasons why you may not be able to find information on a particular medicine:
- The medicine may have been authorised using national procedures. To find information on these medicines, contact the medicines regulatory agency in your country.
- The medicine may still be being evaluated. The Agency only makes full information available on the medicines it evaluates once the evaluation procedure is complete. Limited information is available on human medicines that are under evaluation.
- How long does it take for a medicine to be evaluated by the Agency?
In general, the Agency will issue an opinion on its evaluation within 210 'active' days. However, the clock may be stopped during the procedure to allow companies to answer questions posed by the Agency's Committees. This leads to the actual evaluation time being longer.
- Can the Agency tell me when a medicine will be approved?
The Agency only releases limited information on medicines that are under evaluation. Once the Agency has completed its evaluation of a medicine, it publishes a document summarising its opinion.
The European Commission follows the opinion of the Agency in almost all cases. It takes around two months for the European Commission to approve a medicine after the Agency has given a positive opinion.
- How can I keep up to date with the Agency's opinions?
After every meeting of the main human and veterinary committee meetings, the Agency issues a news release with highlights of the meeting. To stay up to date with the latest news, features and publications from the Agency, you can subscribe to our RSS feeds.
The Agency also publishes a monthly newsletter called 'human medicines highlights'. This newsletter provides key information on the Agency's recent activity on human medicines.
Questions about the evaluation of other substances
- How are medical devices evaluated?
Medical devices are evaluated by the medicines regulatory authorities in each Member State. However, the Agency can be consulted on medical devices that contain medicinal substances.
- How are food supplements evaluated?
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.
- How are cosmetics evaluated?
Cosmetics are evaluated by authorities in each Member State. They are not evaluated or licensed by the Agency.
Questions about conflicts of interest and transparency
- How are the Agency's committee members selected?
Most of the members of the Agency's six scientific committees are nominated by the Member States or the European Commission. The Agency's Management Board is also made up of representatives of Member States and members nominated by the European Commission.
- How are conflicts of interest monitored?
The members of the Agency'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. Every member and expert must make an annual declaration of their financial interests. These are publicly available.
- How is the financial transparency of patient and consumer organisations evaluated?
The Agency 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.
More information: Working with patients and consumers
Questions about the availability of medicines
- How can I get hold of a medicine that is not yet authorised?
Medicines cannot be placed on the market without authorisation. However, some medicines can be supplied to individual patients under strict conditions before they have been authorised. These include clinical trials and compassionate-use programmes. These are regulated by Member States and are outside the responsibility of the Agency.
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.
For information on clinical trials, talk to your doctor or nurse. You can also see information on clinical trials ongoing in Europe in the European Union Clinical Trials Register.
- My medicine has been evaluated by the Agency but is not available in my country. Why not?
Decisions on where a medicine is marketed are made by the company that markets the medicine (the marketing-authorisation holder). The Agency has no control over these decisions. This means that medicines that have a received central marketing authorisation via the Agency 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.
- Does the Agency have information on the availability of medicines in Member States?
No, the Agency 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.
- Can you help me to get hold of a medicine?
No, the Agency does not have any commercial interests and does not get involved in the distribution of medicines. The Agency's responsibilities are limited to the evaluation of medicines for authorisation purposes and their supervision once they are authorised.
The Agency is also unable to give any financial assistance to patients who are trying to get hold of a medicine.
The Agency suggests that you discuss your treatment with a healthcare professional, such as a doctor or pharmacist.
More information: What we do
Questions about pricing, advertising, sales and patents
- Does the Agency have any information on the price or reimbursement of medicines in Member States?
No, decisions on pricing and reimbursement are made at a national level following negotiations between governments and pharmaceutical companies. The Agency is not involved in these decisions and does not have any information on pricing or reimbursement arrangements in Member States.
- Does the Agency control advertising of medicines?
No, advertising of medicines is controlled by medicines 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 by law.
- How can I get sales figures for a medicine?
The Agency 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.
- Can the Agency provide me with information on patents on medicines?
No, the Agency is not responsible for patents on medicines: issues regarding patent law are not within the Agency's remit. The European Patent Office may be able to provide information on a specific patent.
More information:European Patent Office
Questions about medical advice
- Can the Agency give me any advice on my treatment or medical condition?
No, the Agency cannot advise individual patients on their treatment or condition. The Agency suggests that you discuss these issues with a healthcare professional, such as your doctor or pharmacist.
- I am experiencing a side effect from a medicine. What should I do?
The Agency is not in a position to provide medical advice or to confirm whether your symptoms are being caused by your medicine or not. The Agency recommends that you consult your doctor or pharmacist about any suspected side effect from your medicine. Information on the side effects seen with a medicine authorised via the Agency is available in the European public assessment report (EPAR).
More information: Search human medicines
- Can you recommend a medical specialist for my condition?
The Agency does not maintain a list of medical specialists and is unable to advise individual patients on where to seek treatment.
Questions about clinical trials
- How can I get onto a clinical trial?
The Agency 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. You can consult the European Union Clinical Trials Register for information on authorised clinical trials that are ongoing.
Questions about fees
- How are fees organised at the Agency?
The European Medicines Agency charges pharmaceutical companies fees for the services it provides. The Agency 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.
More information: Fees payable to the Agency
How useful is this page?
Average rating:Based on 105 ratings
Add your rating:
- See all ratings
72 ratings10 ratings1 ratings7 ratings15 ratings