MAH Registration

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We are pleased and proud to announce that the Slovak Medicines Verification System is connected to the EU Hub production environment from 26th June 2018. At the same time, we announce that we have launched the MAH registration through our MAH registration portal.
Registration is not for pharmacies and distributors!
Zaregistrujte sa

Who can sign up?

Registration is for MAHs themselves but also for companies representing one or more MAHs on the basis of a letter of attorney (template of a letter of attorney can be find here).

How to register?

Registration consists of 4 main sections:

  1. User login
  2. Company Information / MAH
  3. Authorization of the Company / MAH (SOOL authorizes Company / MAH)
  4. Signing and Upload the Contract

User login​

  • the user can switch language in the top right corner
  • the user in the opening window will click on the “Sign up” button.
  • then fill in the base information about the user, the Company Name / MAH and the Tax Identification Number under which this entity is headed.
  • if you add more MAHs, you need to enter only one (first) and in the next steps you can add other MAHs.
  • after completing the data, you will receive an email to verify the correctness of the entered data.

Company Information / MAH​

  • at this point, it is necessary to enter all required company / MAH information.
  • enter a contact person (SPOC) who will be authorized to communicate with SOOL.
  • enter an authorized representative who can legal act behalf of the company / MAH.

 

– add all MAHs whose company it represents (if there is only one MAH – the data is filled in automatically but needs to be confirmed).

MAHs

  • Marketing Authorization Number = registration number of The State Institute for Drug Control (in the case of centralized medicines, only those marketed on the Slovak)
  • Marketing Authorization Name = only Product Name, No Strength and Quantity

 

If you have more products (more than 20), the list can also be uploaded via the Excel report, which you can email us. In this case, upload only one product and send others by email.

- finally, it is necessary to confirm the correctness of entering all the data. After confirmation, the form will be sent for authorization. After the data has been submitted for authorization, the Company / MAH may look at the concept of the contract. The final version ready for signature can only be downloaded after authorization.

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