This duty is provided for in Section 37(4) of the Code of Administrative Procedure.
Marketing authorisation holders were informed of this duty at the registration seminar in June 2013 and have been informed thereof continuously by the Institute’s staff in pending administration proceedings. Submitted documents will be accepted only if submitted in the following form:
Options available to marketing authorisation holders
Additional submissions in national procedures may be submitted as follows:
-
delivered on a CD/DVD with a cover letter, eventually an application form from the authorised representative, bearing his or her original signature,
-
sent to electronic mail room (posta@sukl
cz) if the file size does not exceed 15 MB (including the certified electronic signature of the authorised representative),
- sent to the data box of the Institute by the authorised representative if the file size does not exceed 10 MB,
- sent via CESP, a cover letter, eventually an application form must contain at least a scanned signature of the authorized representative.
Additional submissions during MR/DC procedures may be submitted as follows:
- sent via CESP, a cover letter, eventually an application form must contain at least a scanned signature of the authorized representative (as of 1. 7. 2019, common documentation for all applications for marketing authorisation, variations to and renewals of marketing authorisation via MR/DC procedures shall be submitted exclusively via the CESP portal).
Submissions of national translations of product information and agreement with final wording of product information in MR/DC procedures may be submitted as follows:
-
delivered on a CD/DVD with a cover letter from the authorised representative, bearing his or her original signature,
-
sent to electronic mail room (posta@suklcz) if the file size does not exceed 15 MB (including the certified electronic signature of the authorised representative),
- sent to the data box of the Institute by the authorised representative if the file size does not exceed 10 MB,
- sent via e-mail, including the certified electronic signature of the authorised representative (general email address: mrp@suklcz),
- sent via eudralink,
- sent via CESP, a cover letter must contain at least a scanned signature of the authorized representative.
In addition to the dossier submitted as described above, powers of attorney containing an authorisation for an unspecified number of a particular subject - related proceedings that will be initiated in future, must be delivered with the original signature by post or courier, the grantor’s signature must be officially certified. Powers of attorney for a particular proceeding may be submitted in copy.
The foregoing applies to all domestic and foreign entities subject to regulation.
Marketing Authorisation Section
1. 7. 2014 (update 18. 9. 2020)
