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Submission of the marketing authorisation application via DCP, MRP

Submission of the marketing authorisation application via DCP, MRP

 

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. Both Slovak Application form and European Application form should be enclosed to the electronic system eApplication.

 

2. The Applicant submits the originally signed of the Cover letter, similar to a standard one, in the Slovak language:

Marketing Authorisation Application (SK)

http://www.sukl.sk/buxus/docs//Registracie/Tlaciva/2011/Ziadost_o_registraciu_SK_111201.doc

and concomitantly submits a printed European Application form:

Application for a Marketing Authorisation (EN)

http://esubmission.ema.europa.eu/eaf/release_19/maa_human_v1.19.0.1.pdf

 

3. Original or copy signed by Notary Public of updated extract from the register of entrepreneurs for proposed MAH for Slovakia (not older than 3 years and only in case SUKL does not have original version or copy signed by Notary Public).

 

4. Annex 5.4 Letter of authorisation for communication on behalf of the applicant/MAH (the signatures must be officially authenticated by a notary or Administrative official).

Letter of authorisation for person/company residing in the Slovak Republic authorized by the MAH to represent and act in the name of the MAH should be submitted in the national phase at the latest. Signed by person listed in the extract from the register of entrepreneurs

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

In the case of change in the Letter of authorisation we ask to send also the withdrawal of the previous authorization, otherwise all authorizations remain valid.

 

5. In case an Applicant is different from proposed MAH in Slovak Republic Statement for the MA transfer to local subsidiary (SK originally signed) (you can use a following template: http://www.sukl.sk/buxus/docs//Registracie/Tlaciva/TRANSFER_AGREEMENT.doc)

 

6. In accordance with §48, art.1, r) of Act No. 362/2011 samples of the finished medicinal product and reference substances should be submitted with the Marketing Authorisation Application by the Applicant (only in case SUKL acts as RMS).

 

7. Format of dossier:

eCTD

Slovak form of the application should be located in Module 1, section – m1- additional data.

National requirements for this format are available at

http://www.sukl.sk/sk/registracia-humannych-liekov/elektronicke-podanie-ziadosti?page_id=3897

 

8. Submission of dossier:

a) CESP Portal - from 2nd of November 2015, it is possible to submit dossiers via the electronic system - CESP Portal. Please note, that via the CESP portal it is possible to send Dossiers only in eCTD/Nees format.

b) CD/DVD with a cover letter - via OPAP (Registry and Administrative Support Department) or via courier

 

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