Notice to applicants concerning the registration of the medicinal product for a national procedure, decentralized procedure and mutual recognition procedure.
State Institute for Drug Control announces that with effect from 1.6.2012 will receive documentation for applications for new Marketing Authorisation applications (and subsequent variations) in electronic form, in the eCTD format for electronic media - CD / DVD.
The electronic form and a strong recommendation for its use in submitting applications in the eCTD format are modified in European documents approved by European working groups TIGes and ICH. National requirements for documentation submitting at SIDC in the eCTD format, as well as the most common errors in administration documents, have been specified according to the pilot project applications in the eCTD format (in operation since 2011) and discussed with representatives of marketing authorization holders at Workshops in 2011, organized at this topic.
National requirements:
It will be necessary to continue in submitting the part of Module 1 in paper documents:
1) Cover Letter
2) English application form (the required number of copies)
3) Slovak application form (the required number of copies)
4) Proof of payment generated from eApplication system (Annex 5.1)
5) Extract from the Trade Register of the holders (Annex 5.3) in original or notary certified copy
6) The authorization for the contact persons (Annex 5.4) *
7) The certificate of the MA transfer to the subsidiary or another company, if it is relevant (if the applicant is not as the same as the future holder Part 2.4.1 of the application) *
* template of documents at SIDC web site: http://www.sukl.sk/sk/registracia-humannych-liekov/tlaciva?page_id=2508
