Calyx RIM Administration

m1-au v. 3.1

Field Name Field Type Matching UI Field Description Acceptable Values Default Value
esubmissionIdentifier string eSubmission Identifier The Application Number as provided by the agency. Default value is Application Code. The value should consist of the small EN letter and 6 digits ([a-z]([0-9]{6})
applicant string eBS Client ID Identifies the type of activity that is being submitted with the sequence, either the regulatory activity type if it is the first sequence of the regulatory activity, or supplementary information if it is a follow-up to information already submitted for the regulatory activity.
australianApprovedNames string Approved Name(s) The name of the active ingredients that are accepted for inclusion in the Australian Approved Name list. Multiple comma-separated values can be provided.
productName string Trade Name(s) The name or proposed product (trade) name to be used on the Certificate of Registration. Multiple comma-separated values can be provided.
artgNumber string ARTG Number(s) The Australian Register of Therapeutic Goods number should be provided if available. The ARTG can be a four, five, or six digit number
submissionOrApplicationNumber string Submission of Application Number(s) The submission number(s) or application number(s) applicable to the sequence being submitted. Multiple comma-separated values can be provided.
sequenceNumber string Sequence Number The Sequence Number for this submission. Sequence Code (without prefix "P")
relatedSequenceNumber string Related Sequence Number Four-digit sequence number used for supplementary information indicating the initial sequence number of the regulatory activity.
regulatoryActivityLead string Regulatory Activity Lead Identifies the group within the TGA which is expected to take the lead in the review process.

The regulatory activity lead defined list of codes and values is managed at <http://apps.tga.gov.au/downloads/reg-activity-lead.xml>. Applicants should refer to this list for current list values.

eCTD Code value from Data Administration > Regulatory Activity Lead Values
submissionMode string Submission Mode Until the work grouping and work sharing functions are sufficiently developed for specific guidance to be published, the only valid mode is 'single' which denotes a single regulatory activity. One of "single", "work-sharing", "work-grouping"
sequenceType string Sequence Type Identifies the type of activity that is being submitted with the sequence: either the regulatory activity type if it is the first sequence of the regulatory activity, or supplementary information if it is a follow-up to information already submitted for the regulatory activity.

The sequence type defined list of codes and values is available from <http://apps.tga.gov.au/downloads/sequence-type.xml>.

eCTD Code value from Data Administration > Filing Type Values > Filing Type eCTD Code
sequenceDescription string Sequence Description Content description for the submitted sequence should be one of the values from the defined list. Codes have been implemented to help provide consistency of input and reduce validation issues based on semantics of values.

The sequence description defined list of codes and values is available from <http://apps.tga.gov.au/downloads/sequence-description.xml>.

eCTD Code value from Data Administration > Sequence Description Values
xValue1 date Belongs to the sequenceDescription field.

In the UI, the sequenceDescription field is a list with values, some values have or do not have additional parameters.

If customer selects a value with no additional parameter, then the system yields the following XML (see example): 
 <extensions>
  <extension type="m1-au" version="3.1">
   <field name="sequenceDescription" type="string" >seq-desc-0000</field>
  </extension>
 </extensions>
There are four types of additional parameters:
  1. date
  2. date range (i.e. two dates, "from date" and "to date")
  3. number and date
  4. description
If a customer selects the 1st type of additional parameter, the system yields the sequenceDescription field and date (see example): 
 <extensions>
  <extension type="m1-au" version="3.1">
   <field name="sequenceDescription" type="string" >seq-desc-22</field>
   <field name="xValue1" type="date" >1487887200000</field>
  </extension>
 </extensions>
If a customer selects the 2nd type of additional parameter, the system yields the sequenceDescription field and date range (see example): 
 <extensions>
  <extension type="m1-au" version="3.1">
   <field name="sequenceDescription" type="string" >seq-desc-20</field>
   <field name="xValue2From" type="date" >1487887200000</field> <!-- first date  -->
   <field name="xValue2To" type="date" >1487973600000</field>   <!-- second date -->
  </extension>
 </extensions>
If a customer selects the 3rd type of additional parameter, the system yields the sequenceDescription field and number/date pair (see example): 
 <extensions>
  <extension type="m1-au" version="3.1">
   <field name="sequenceDescription" type="string" >seq-desc-19</field>
   <field name="xValue3" type="map"> <!-- it is predefined value -->
    <value key="999__uniqueSuffix__0" value="24-Feb-2017" /> <!-- number/date pair -->
   </field>
  </extension>
 </extensions>

Where:

999__uniqueSuffix__0 - it is xValue3_text, "999" is number and "__uniqueSuffix__0" is predefined suffix

24-Feb-2017 - it is xValue3_date

If a customer selects the 4th type of additional parameter, the system yields the sequenceDescription field and description (see example): 
 <extensions>
  <extension type="m1-au" version="3.1">
   <field name="sequenceDescription" type="string" >seq-desc-0004</field>
   <field name="xValue4" type="string">description for sequenceDescription</field> <!-- description -->
  </extension>
 </extensions>
xValue2From date
xValue2To date
xValue3 map
xValue3_text string
xValue3_date date
xValue4 string
email string Contact Email The email is used to notify the applicant in case of change in application status. Must be valid email format. The value must represent a valid e-mail, the validation mask is ^([\sa-zA-Z0-9._%-]+@[a-zA-Z0-9.-]+\.[a-zA-Z]{2,4})$