Additional requirements for submission of the dossier in the Slovak Republic

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.

2. The Applicant submits the Marketing Authorisation (variation or renewal) Application form filled-in in Slovak language:

Žiadosť o registráciu humánneho lieku (SK)

Žiadosť o zmenu v registrácii humánneho lieku (SK)

Žiadosť o predĺženie platnosti rozhodnutia o registrácii humánneho lieku (SK)

Oznámenie o zmene podľa článku 61 (3) (SK)

and concomitantly submits filled-in an European Application form:

Application for a Marketing Authorisation (EN)

Application for a Marketing Authorisation - Homeopathic (EN)

Application for a Variation to a Marketing Authorisation (EN)

Application for a Renewal of a Marketing Authorisation (EN)

Announcement of a Variation according to Art. 61(3) (EN)

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 Application for Marketing Authorisation by the applicant. Only when Slovak Republic acts as concerned member state (CMS) it is not necessary.

3. The Application for a Transfer of a Marketing Authorisation (change in the Marketing Authorisation Holder) is bi-lingual, so it is not necessary to combine Slovakian and EU Application Forms

Application for a Transfer of a MA (SK)

4. The Applicant submits the Application forms to the SIDC in the following number of copies

5. The proposed SmPC, PIL, and Labelling should be submitted electronically in the Slovak language (according to the Act. No.362/2011 §48 art. 1   l), m) and n), on medicinal product and medical devices), within five days after the start of the national phase of registration (or variation or renewal). Current coloured Mock-ups should be submitted in a hard copy within five days after national approval of Labelling. The SmPC, PIL and Labelling should be in line with the current version of the QRD published at:

http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000254.jsp&murl=menus/regulations/regulations.jsp

6. The Abstract from the Business Record of the Applicant and the future Marketing Authorisation Holder (original or Notary verified copy). An original or Notary Public verified copy is necessary only in the case when an Applicant and if different also the future MAH are submitting an Application in the Slovak Republic the first time. In opposite a copy of an Abstract from the Business Record of the applicant and the future MAH is sufficient.

7. Copy of GMP certificates and Manufacturing Authorizations:

• o in the case the manufacturing site is in the EU, EEA (Norway, Iceland, Liechtenstein), or in countries, to which an appropriate MRA refers to (Canada, Australia, New Zealand, Japan, Switzerland):
• o a copy of Manufacturing Authorization from EU, EEA or MRA countries - not older than 3 years, and
• o a copy of GMP certificate from EU, EEA or MRA countries - not older than 3 years in the case the GMP statement is not already a part of Manufacturing Authorization.
• o in the case the manufacturing site is in third countries:
• o an original or verified copy of Manufacturing Authorization from the competent authority of the relevant country -not older than 3 years and original or verified copy of the GMP certificate issued by country from EU, EEA or MRA - not older than 3 years

8. Certificate of the MA transfer, when an Applicant is different from proposed MAH in Slovak Republic (i.e. not belonging to the same mother company or group of companies or which are "licensees").

9. In the case when the Applicant submits Applications for a Marketing Authorisation of more than one strength, parts of the documentation (Modules 1 to 5) which are identical for all strengths should be submitted in a hard copy only once. In these cases the other documentation (Modules 1 to 5), except of the Applications, should be submitted on CDs only.

10. The applicant may submit Modules 2, 3, 4, and 5 electronically, when he gives the statement on submitting full paper version of documentation of Modules 2, 3, 4, and 5 on the request of the SIDC within 14 days.

11. 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) z) of the Act No. 362/2011 Coll. on medicinal products and medical devices as amended.

12. Annex 6.4. Authorization of communication in the name of Applicant/Marketing Authorization Holder, signed by person listed in the extract from the register of entrepreneurs (commercial register, proof of establishment). (An original or verified copy is necessary only in the case when the Applicant/ Marketing Authorization Holder authorizes the person for the Slovak Republic the first time In contrary a copy is sufficient. In the case of change in the authorization we ask to send also the previous authorization, otherwise all authorizations remain valid.)