December 2022
In the case of submission of applications that do not have an application and documentation submitted in eCTD format via the CESP portal (for example, a application for transfer, a application for withdrawal a medicine,...), the submission of applications and documentation is necessary to start the administrative procedure:
- in electronic form signed by the KEP signature
- in paper form, originally signed
- in person through the Client Center (CC) or the SIDC Registry Office (in the case of submitting applications for SRL - mainly use the CC)
- by mail
- by courier
You can find more information regarding all the requirements for submitting "Applications" here.
Electronic submission of Applications for SRL
- through the form published on the Central Public Administration Portal (slovensko.sk)
- it is inevitable to use eID (electronic identity card) and KEP (Qualified Electronic Signature)
- the filing date is the day when the given application is delivered to the State Institute for Drug Control
more information can be found here or here
The electronic form can be submitted in 2 ways:
- using the "General Submission" electronic service
We recommend writing out the type of request (e.g. Request for the transfer of ABC medicine, etc.) and it is necessary to insert the request as an attachment, which must be signed by the KEP.
This means that an unsigned form + a signed attachment is considered an electronic application.
- using the electronic service "Submission of a request for the withdrawn of a human medicinal product / for the transfer of a human medicinal product, ...."
- the selected form is completely filled out and the KEP is signed.
- the selected form will not be printed, it will remain empty, within it a Slovak application in PDF format will be attached as an attachment, which will be signed by the KEP signature, the form does not need to be signed.
This means that an unsigned form + a signed attachment is considered an electronic application.
Notification of the receipt of applications and the allocation of a registration number will be sent to the e-mail address of the contact person for the Slovak Republic, which is listed in eAF, or of the person who submitted the application or whose authorization (original or notarized copy) was delivered to SIDC.
Practical advice
- it is better to use a paper form for requests for the transfer of the holder, when the signature of 2 different persons is required. However, if the same person accesses both the original and the future sender, it is possible to submit such a request electronically.
- Submission of applications according to should only be carried out by a specified natural person with permanent residence or a legal entity based in the territory of the Slovak Republic authorized by the holder of the decision on the registration of the drug to represent him and act on his behalf.
- It is necessary to attach attachments such as SmPC, PIL, OBL, Cover letter, etc. if they are not available in the sequence submitted via CESP
- Before sending the request, whether ASICE is present with KEP signature
What is a KEP signature?
The KEP signature is equipped with an electronic signature, which in the electronic world is the equivalent of a handwritten signature in written communication. You can find more information at slovensko.sk.
