Submission of the marketing authorisation applications via DC, MR procedures – national requirements

updated September 2024

Administrative fee (item No. 152 of the Act No. 145/1995 on administrative fees as amended) is to be paid by the Applicant at the time of submission of the Application (according to §142 art. 2 of the Act No. 362/2011 on medicinal products and medical devices). For payment of administrative fees it is necessary to use the eKolok payment system operated by Slovenská pošta a.s. More information about the service as well as a more detailed description of the recommended payment options can be found here.

2. Scan/copy of extract from the register of entrepreneurs of proposed MAH in the Slovak Republic (not older than 3 years) needs to be submitted as Annex 5.3.

3. Annex 5.4 Power of Attorney (PoA) or Letter of authorisation (LoA) for communication on behalf of the applicant/MAH for a natural person/juridical person residing in the Slovak Republic authorised by the MAH to represent and act in the name of the MAH should be submitted during national phase at the latest.

More information can be found here

PoA/LoA should be signed with/provided as:

Wet signature
True copy authentificated by the Notary
Qualified electronic signature by the MAH
Valid electronic signature

The original PoA/LoA for each procedure is only necessary in case that SIDC does not have the original version of general PoA/LoA of acting parties.

If any change in PoA/LoA occur, withdrawal of the previous authorisation should be submitted.

4. In accordance with §48, art.1, r) of Act No. 362/2011 samples of the finished medicinal product should be submitted only upon ŠÚKL´s request in case that Slovak Republic acts as a reference member state.

5. Format of the dossier:

eCTD

National requirements for this format are available here and here

6. Submission of the dossier is possible via CESP Portal only.

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