The portal is provided with a general user manual and specific instructions for every single document form. There are 21 different document forms in English and altogether 50 document forms in Estonian.
The portal requires registering with an Estonian id-card or simply your e-mail address. There are several user account types available - read the information about registration before you choose which type to use.
More information can be found from the frequently asked questions' section (down) or you can always send us an e-mail: [email protected].
The portal allows you to fill in the following documents in English.
Import and export
- Application for an import authorisation of medicinal products requiring special authorisation
- Application for an export authorisation of medicinal products requiring special authorisation
- Application of import authorisation of goods requiring special authorisation
- Application of export authorisation of goods requiring special authorisation
- Application of import authorisation of narcotic drugs and psychotropic substances
- Application of export authorisation of narcotic drugs and psychotropic substances
- Notifications of import of medicinal products
- Notifications of export of medicinal products
- Notification of import of medicinal products for use in clinical trial
- Notification of export of medicinal products for use in clinical trial
- Notification of import of cells, tissues and organs
- Notification of export of cells, tissues and organs
- Clinical trial application
- Amendment notification for clinical trial
- Declaration of the end of clinical trial
- Suspect adverse reaction report (CIOMS)
- Report form for advertising pharmaceuticals
- Notification of placement of medicinal product on the market
- Notification of importer of the medicinal product
- Notification of difficulties in the supply
- Notification of withdrawal of the marketing authorisation
Documents available only in Estonian:
- Activity licence applications for handling medicines (pharmacies, wholesale distributors)
- Activity licence application for handling cells, tissues and organs.
- Application for the use of an unauthorised medicinal product (doctors, veterinarians)
- Quarterly reports on pharmacy's activity
- Quarterly wholesale report
- Quarterly report of handling substances subject to special recording
- Notifications of serious adverse reactions or events (cells, tissues, organs)
- Reports on investigating the serious adverse reactions or events (cells, tissues, organs)
- Yearly reports on serious adverse reactions or events (cells, tissues, organs)
- Notification of serious adverse reactions or events (blood)
- Reports on incestigating the serious adverse reactions or events (blood)
- Yearly report on serious adverse reactions or events (blood)
Which documents can I fill in and send via Client Portal?
The list of document forms available in English and in Estonian can be found here.
How to register?
Before registering take some time to read user manual or "How to register?" and decide which type of user account suits you best. Then click "Register" on the front page of Client Portal and follow the instructions. More detailed information about filling in the sign-up-form can be found under the link "Help" in the top-right corner of the form. You
Do I need an Estonian ID-card to register?
ID-card is needed to open an account for a natural person from Estonia. It is also recommended that enterprises registered in Estonian Central Commercial Register would be registered by their representatives with Estonian ID-card. Foreigners can register as natural persons or enterprises using their e-mail address, ID-card is not needed.
I'm a foreigner. How can I register?
Foreigners without Estonian ID-card should register as foreign natural persons or enterpriseses. You don't need an ID-card for that. In case the documents need original signature, you should print out the confirmation letter provided by the portal, sign it manually and send it to the agency.
Where can I find more information about filling in the forms?
Every document form comes with detailed instructions about how to fill in the form. The instructions can be found under "Help" in the top-right corner of the form.
Can I attach additional documents?
All document forms in the portal allow you to attach additional documents sized up to 10 MB per one document. The file type or number of files is normally not restricted. However, in some cases only certain specific file types are allowed.
Why aren't there marketing authorisation applications in the Client Portal?
The Common European Submission Portal – CESP is used for marketing authorisation applications in EU (https://cespportal.hma.eu/Account/Login). There is no need for national portal.
What is "doctor's application for the use of unauthorised medicinal product"?
This is an application Estonian doctors and veterinarians use to get a permission to use a medicine without a marketing authorisation in Estonia. Foreign clients don't need this application, therefore it's available only in Estonian.
Can several enterprises share the same user account?
Several enterprises cannot share the same user account. If you need to act for several different enterprises, you should consider using natural person's account or make a different user account for every enterprise.
Why can't I log in?
Make sure you have chosen "user name" in the login box and your caps lock is off. If problems persist, contact the agency.
If you're trying to log in with an Estonian ID-card, check if your card is in the reader, then close your browser. Then start your browser and try again. Make sure you have entered your user name - user name is needed even when logging in with ID-card.
Why does Client Portal log me out?
If you're inactive for more than 30 minutes, you will be logged out from the portal. This is for security reasons. The portal warns you about your session ending 3 minutes before logging out. If you see this warning and click "continue" your session will be reactivated and you will be logged in for at least 30 more minutes.
I want to print the document with the acceptance information?
If you open the print-form (printing icon in the top-right corner of the document) you won't see the state of proceeding there. If you need to print out the document with the accepted-sign or other document status, simply choose File - Print from your browser's menu or press CTRL + P on your keyboard.
Last updated: 23.11.2021