ELECTRONICALLY SUBMITTED APPLICATIONS REGARDING MARKETING AUTHORISATION IN SLOVAK REPUBLIC – INFORMATION ON STATUS AND NATIONAL REQUIREMENTS
From July 2011 State Institute for Drug Control, Bratislava, Slovakia has implemented pilot phase of validating electronically submitted application regarding marketing authorization in Slovak republic. The format applicable to the marketing authorisation documentation shall be the eCTD (Electronic Common Technical Document). It is defined as an interface for the exchange of information between applicants/marketing authorisation holders and the regulatory authorities in European Union. It reflects the standard 5- module structure of the dossier. The format of Modules 2 – 5 is stipulated by the requirements of ICH (International Conference on Harmonization) which are uniform for the EU, USA, and Japan and their current version is available from the ICH website):
The format of Module 1 is governed by regional requirements; i.e. for the EU by the requirements drafted by TIGes (Telematics Implementation Group on Electronic Submission); their current version is available from the website of the European Commission):
With respect to the above mentioned facts, during the year 2011, continuous discussion and meetings with stakeholders (pharmaceutical company representatives for regulatory affairs) and Slovak Medicine Agency staff were organized for successful implementation of eCTD in daily practice in Slovak republic.
Outcome from two meetings with stakeholders and Agency on this issue can be found here http://www.sukl.sk/sk/media/spravy-2011/spracovanie-ziadosti-ectd-v-slovenskej-republike?page_id=2844
From July 2011 applications regarding marketing authorisation should be submitted in eCTD format in Slovakia.
Any application and related documentation is strongly recommended to be submitted to the SIDC in electronic format eCTD. The submissions apply to new applications for marketing authorization regardless of the type of procedure (national, MRP, DCP), applications for variations, applications for renewal, application for withdrawal of marketing authorization, applications for transfer of marketing authorization, and applications for take-over of marketing authorization.
REGIONAL (SLOVAK) REQUIREMENTS FOR THE FORMAT OF MODULE 1 ARE AS FOLLOWS:
1. ENVELOPE SK
- For respective application „Tracking number“ for Slovak republic means :
- Procedural number ( for MRP/DCP)
- Registration number, if available (national applications)
- Variable symbol (generated by system eZiadost/eApplication)
- Invented name for the product in eCTD application : „Invented - name“ for Slovak republic means:
- product name submitted and approved in Slovak republic
- When application refers to several strengths or application forms of one product, it is strongly recommended not to refer only to single strength (or form) in envelope, but to give all strengths or forms of the product - or none (example – Alendronat 10 mg, 70 mg or only Alendronat)
2. LABELING OF ELECTRONIC DATA CARRIER (CD or DVD)
- Based on document : TIGes Harmonised Guidance for eCTD Submission in the EU (Version 2.0) following labelling in sticker is required for data carrier:
- Form of application (for example - eCTD)
- Applicant name
- Product name
- Active substance name
- Procedural number (MRP/CDP)
- Registration number, if available (national applications)
- Sequence number (if carrier contains more sequences those have to be listed in enclosure)
- Number of carrier / total number of carriers, if application is in more carriers – for example 1(3), 2(3), 3(3).
- Type of application (Initial Application, Variation Type, Supplemental info, etc.)
- Based on regional (Slovak) requirements we strongly recommend providing also variable symbol generated by system eZiadost/eApplication on labelling.
3. SLOVAK FORM OF APPLICATION together with English form should be located in Module 1, section – m1- additional data.
4. MARKETING AUTHORISATION HOLDER (MAH) TRANSFER as a part of application when applicant differs from proposed MAH in Slovak republic (applicant „on contract“ – not a member of proposed MAH) should be a part of Module 1 section – m1- additional data.
5. LIFE CYCLE MANAGEMENT FOR PRODUCT
Validation of eCTD applications officially started since July 2011 in Slovak medicine agency. Electronic data carriers (CDs or DVDs) submitted before July 2011 will be validated and downloaded to central agency depository of licensed medicines retrospectively in the following months. Nevertheless, validation report for new applications can contain information about non complete Life cycle management in spite you may have submitted eCTD applications in past. We kindly ask you if possible, in the case of negative Life cycle management criteria in validation report for your eCTD application to re-send us missing sequences.
MOST FREQUENT DEFICIENCIES IN ECTD APPLICATIONS IDENTIFIED FROM JULY 2011 BY SLOVAK MEDICINE AGENCY:
We have informed applicants in past about most frequent deficiencies in eCTD applications which were validated from July 2011. Most frequent deficiencies which do not meet international requirements drafted by TIGes are as follows:
1) Files are protected by password
2) Sequence is compressed to one file ( for example „0000.zip“)
3) Application is compressed to one file ( for example de-h-1245.zip“)
4) Labelling of data carrier is insufficient (see also “Labeling of electronic data carrier”)
5) Sequence is burned to data carrier as route address (for example „D:\0000“)
6) Existence of non-conforming files in CD generated by Windows („Thumbs.db“)
7) DOS 8.3 named files („JUSTIF~2.PDF“)
8) Use of non-conforming attributes
9) Missing of route address and missing of sequence address (D: \index.xml“)
