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PROCESSING OF ELECTRONIC SUBMISSION ECTD – ONGOING ISSUES

eCTD (Electronic Common Technical Document), is a standard format and interface for electronic delivery of documentation submitted to Medicines Agency for the purposes of registration of medicines or variations. eCTD structure is based on CTD format (Common Technical Document).

The intensive preparations are underway for the implementation of electronic filing and processing applications (eCTD) in practice. Launch of this process is by the end of 2011. For the success of the eCTD project is inavitable that applicants are familiar with the requirements to fill an application and its identification.

Up to 10th June 2011 37 applications submitted to SIDC in eCTD format have been tested. Only 3 applications fully meet the validation criteria of eCTD version 3.1. see enclosure 1. Validation report.

 

Deficiences found in identification of e-application

The following imperfections have been identified:

  1. in SK section envelope the product names were not mentioned as registered in SK,
  2. the Tracking Number (s) in applications for variation is blank,
  3. in application for variation for more products is developed only a comprehensive sequence while sequences should be developed for each registration number and must include documentation separately for each registration number,
  4. Submission type does not comply with data in e-application,
  5. Applicant is not the same as Marketing Authorisation Holder.

 

Incorrect identification of e-applications will lead to a refusal.
Therefore, please note applicants for registration or a variation of human medicines to comply with the following basic requirements for the identification of the application filed in eCTD format
:

 

  1. each request sent to the SIDC is necessary to generate a separate CD / DVD.
  2. for each registration number in Slovakia (for each strength, each pharmaceutical form), or procedural number (MRP, DCP) to which the application relates is necessary to create a separate directory and the directory name, which is derived from the registration number, number of procedure or product name.

 

Example:

incorrect:    one directory for / DK-H-9999-001-002-003-004

correct:        for directories

DK-H-9999-01

DK-H-9999-02

DK-H-9999-03

DK-H-9999-04

 

Which will include respective sequences and documentations.

  1. In addition, cover CD / DVD should include variable symbols if  assigned to the e-application and other identifying information about the product and the applicant, as required, see enclosure Seminar 01032011.pdf
  2. Tracking Number (s): registration number and variable symbol should be correctly mentioned in envelope of application, in older applications  Process number is acceptable.
  3. Invented Name as registered in SK should be correctly mentioned in envelope
  4. Type of varion is required to be mentioned in envelope, section Submission Description.

 

More information and instructions for applicants were presented at the Seminar held on 1st March 2011.

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