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

  1. 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). In order to obtain a Variable symbol, which is an identificator of payment by bank transfer, please use electronic system eApplication. European Application form  (eAF) should be attached to the electronic system eApplication.

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

 

  1. Annex 5.4 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 MAHshould be submitted during national phase at the latest.

LoA should be signed with/provided as:

  • Wet signature
  • True copy authentificated by the Notary
  • Qualified electronic signature by the MAH
  • Electronic signature (DocuSign)

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

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

  1. If applicant is different from proposed MAH in the Slovak Republic a Statement of the MA transfer to local subsidiary(with wetsignature) should be submitted during the national phase at the latest.

Following template could be used: http://www.sukl.sk/buxus/docs//Registracie/Tlaciva/TRANSFER_AGREEMENT.doc)

  1. 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.

  1. Format of the dossier:

eCTD

National requirements for this format are available at

https://www.sukl.sk/hlavna-stranka-1/english-version/registration-of-medicinal-product/instructions/procedure-for-submitting-registration-documentation-to-sidc?page_id=6053

https://www.sukl.sk/hlavna-stranka-1/english-version/registration-of-medicinal-product/instructions?page_id=1056

 

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

 

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