Switzerland-v1.2

Attribute Description
Agency The name of the receiving agency for the submission: Swissmedic
Applicant The name of the company submitting the eCTD. Entered as "n/a" (case sensitive) if the submission is a DMF (Drug Master File) or PMF (Plasma Master File).

Application

Number

The application number as provided by the agency. Multiple comma-separated values can be provided.
DMF Holder The name of the company submitting the DMF. Entered as "n/a" (case sensitive) if the submission is not a DMF.
Attribute Description
DMF Number The number assigned to the DMF. Entered as "pending" (case sensitive) if the assigned DMF number is not known. Entered as "n/a" (case sensitive) if the submission is not a DMF.
INN International Nonproprietary Name, used to identify pharmaceutical substances or active pharmaceutical ingredients. Multiple comma-separated values can be provided.
Invented Name The name of the medicinal product. Enter an invented name even if it is not yet definitive. Entered as "pending" (case sensitive) only as a last choice. Multiple comma-separated values can be provided.
Paragraph 13 TPA Identifies the submission as Paragraph 13 TPA.
PMF Holder The name of the company submitting the PMF. Entered as "n/a" (case sensitive) if the submission is not a PMF.
PMF Number The number assigned to the PMF. Entered as "pending" (case sensitive) if the assigned PMF number is not known. Entered as "n/a" (case sensitive) if the submission is not a PMF.
Related Sequence The sequence number of a previous submission to which the submission is related. Enter the numeric value (must have 4 digits) or, if there is no related sequence, enter "none" (case sensitive). Multiple comma-separated values can be provided.
Sequence Number The sequence number of the submission. The default is from the sequence code, but can be overridden.
Submission Description The description of the submission to be included in the XML.
Submission Type The type of procedure for the submission.