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Submission of the marketing authorisation application via national procedure

Submission of the marketing authorisation application via national procedure

 

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 Marketing Authorisation Application form filled-in in 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

Application for a Marketing Authorisation - Homeopathic (EN)

http://www.sukl.sk/buxus/docs//Registracie/Tlaciva/2010/Ziadost_o_registraciu_-_Homeopatika_EN.doc

 

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

 

4. The Marketing Authorization Holder is obliged to set physical person or legal entity residential in the Slovak Republic authorized by the Marketing Authorization Holder of the medicinal product to represent and act in the name of the MAH. This requirement results from § 60 (1) x) of the Act No. 362/2011 Coll. on medicinal products and medical devices as amended.

Letter of authorisation should be signed by person listed in the extract from the register of entrepreneurs. An original or verified copy is necessary only in the case when the Applicant/ MAH authorizes the person for the Slovak Republic the first time. In contrary a copy is sufficient. 

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 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

 

6. 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

b) NeeS

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

c) CTD

 

7. 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

c) On paper via OPAP (Registry and Administrative Support Department) or via courier

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