<!DOCTYPE ichicsrack [

<!--
INDIVIDUAL CASE SAFETY REPORT 
XML ACKNOWLEDGMENT DOCUMENT TYPE DEFINITION
This XML DTD is based on the ICH M2 ICSR ACK DTD version 1.0 and may be used to generate instances compliant with the ICH specification. 
-->


<!-- ==================================================================	-->
<!-- Entities								-->
<!-- ==================================================================	-->

<!-- Use the lang attribute to indicate the language of an		--
  -- elements content via an ISO 639 language Code.			-->

<!ENTITY % lang.att "lang CDATA #IMPLIED">

<!-- Standard Character Entities to escape SGML special characters.     -- 
  -- When "<", ">", and "&" occur in text, they should be replaced      --
  -- by "&lt;", "&gt;", and "&amp;" respectfully.                       -->

<!-- Less Than "<" -->
<!ENTITY lt     "&#38;#60;">

<!-- Greater Than ">" -->
<!ENTITY gt     "&#62;"> 

<!-- Ampersand "&" -->
<!ENTITY amp    "&#38;#38;"> 

<!-- ==================================================================	-->
<!-- Elements and Attributes						-->
<!-- ==================================================================	-->

<!ELEMENT ichicsrack    	- -	
		(ichicsrmessageheader	, 
		acknowledgment)>
<!ATTLIST ichicsrack
	lang	CDATA	#REQUIRED
>

<!-- M.1 ICH ICSR Message Header Information -->

<!ELEMENT ichicsrmessageheader         - -	
	(messagetype			,
	messageformatversion		, 
	messageformatrelease		,
	messagenumb			,
	messagesenderidentifier         ,
	messagereceiveridentifier	,
        messagedateformat               ,
	messagedate)>
<!ATTLIST ichicsrmessageheader
	%lang.att;
>

<!-- M.1.1 Message Type -->
<!ELEMENT messagetype		- - (#PCDATA) >
<!ATTLIST messagetype
	%lang.att;
>

<!-- M.1.2 Message Format Version -->
<!ELEMENT messageformatversion 	- - (#PCDATA) >
<!ATTLIST messageformatversion
	%lang.att;
>

<!-- M.1.3 Message Format Release -->
<!ELEMENT messageformatrelease 	- - (#PCDATA) >
<!ATTLIST messageformatrelease
	%lang.att;
>

<!-- M.1.4 Message Number -->
<!ELEMENT messagenumb	 	- - (#PCDATA) >
<!ATTLIST messagenumb
	%lang.att;
>

<!-- M.1.5 Message Sender Identifier -->
<!ELEMENT messagesenderidentifier - - (#PCDATA) >		
<!ATTLIST messagesenderidentifier
	%lang.att;
>

<!-- M.1.6 Message Receiver Identifier -->
<!ELEMENT messagereceiveridentifier - - (#PCDATA) >
<!ATTLIST messagereceiveridentifier
	%lang.att;
>

<!-- M.1.7a Message Date Format -->
<!ELEMENT messagedateformat     - -     (#PCDATA)>
<!ATTLIST messagedateformat
        %lang.att;
>

<!-- M.1.7b Message Date -->
<!ELEMENT messagedate	- -	(#PCDATA) >
<!ATTLIST messagedate
	%lang.att;
>

<!-- A.1 ICSR Acknowledgment Message-->
<!ELEMENT acknowledgment		- -	
	(messageacknowledgment		, 
	reportacknowledgment*)>
<!ATTLIST acknowledgment
	%lang.att;
>

<!-- A.1 Message Acknowledgment -->
<!ELEMENT messageacknowledgment	- -	
	(icsrmessagenumb		,
        localmessagenumb?               ,  
	icsrmessagesenderidentifier	,
	icsrmessagereceiveridentifier	,
        icsrmessagedateformat           ,
	icsrmessagedate			,
	transmissionacknowledgmentcode	,
	parsingerrormessage?)>
<!ATTLIST messageacknowledgment
	%lang.att;
>

<!-- A.1.1 ICSR Message Number -->
<!ELEMENT icsrmessagenumb	- -	(#PCDATA)>
<!ATTLIST icsrmessagenumb
	%lang.att;
>

<!-- A.1.2 Local Message Number -->
<!ELEMENT localmessagenumb      - -     (#PCDATA)>
<!ATTLIST localmessagenumb
        %lang.att;
>

<!-- A.1.3 ICSR Message Sender Identifier -->
<!ELEMENT icsrmessagesenderidentifier - -	(#PCDATA)>
<!ATTLIST icsrmessagesenderidentifier
	%lang.att;
>

<!-- A.1.4 ICSR Message Receiver Identifier -->
<!ELEMENT icsrmessagereceiveridentifier - -	(#PCDATA)>
<!ATTLIST icsrmessagereceiveridentifier
	%lang.att;
>

<!-- A.1.5a ICSR Message Date Format -->
<!ELEMENT icsrmessagedateformat     - -     (#PCDATA)>
<!ATTLIST icsrmessagedateformat
        %lang.att;
>

<!-- A.1.5b ICSR Message Date -->
<!ELEMENT icsrmessagedate	- -	(#PCDATA)>
<!ATTLIST icsrmessagedate
	%lang.att;
>

<!-- A.1.6 Transmission Acknowledgment -->
<!ELEMENT transmissionacknowledgmentcode - -	(#PCDATA)>
<!ATTLIST transmissionacknowledgmentcode
	%lang.att;
>

<!-- A.1.7 Parsing Error Message -->
<!ELEMENT parsingerrormessage	- -	(#PCDATA)>
<!ATTLIST parsingerrormessage
	%lang.att;
>

<!-- B.1 Report Acknowledgment -->
<!ELEMENT reportacknowledgment	- - 	
	(safetyreportid?                ,
        safetyreportversion?            ,
        localreportnumb?                ,
	authoritynumb?                  ,
	companynumb?			,
	othernumb?			,
        receiptdateformat?              ,
	receiptdate?			,
	reportacknowledgmentcode	,
	errormessagecomment?)>
<!ATTLIST reportacknowledgment
	%lang.att;
>

<!-- B.1.1 Safety Report Identification -->
<!ELEMENT safetyreportid	- -	(#PCDATA)>
<!ATTLIST safetyreportid
	%lang.att;
>

<!-- B.1.2 Safety Report Version -->
<!ELEMENT safetyreportversion   - -     (#PCDATA)>
<!ATTLIST safetyreportversion
        %lang.att;
>

<!-- B.1.3 Local Report Number -->
<!ELEMENT localreportnumb       - -     (#PCDATA)>
<!ATTLIST localreportnumb
        %lang.att;
>

<!-- B.1.4 National regulatory authority's case report number (E2B - A.1.10.1)-->
<!ELEMENT authoritynumb         - -	(#PCDATA)>
<!ATTLIST authoritynumb
	%lang.att;
>

<!-- B.1.5 Company's case report number (E2B - A.1.10.2) -->
<!ELEMENT companynumb		- -	(#PCDATA)>
<!ATTLIST companynumb
	%lang.att;
>

<!-- B.1.6 Other sender's case report number (E2B - A.1.10.3) -->
<!ELEMENT othernumb		- -	(#PCDATA)>
<!ATTLIST othernumb
	%lang.att;
>

<!-- B.1.7a Receipt Date Format -->
<!ELEMENT receiptdateformat     - -     (#PCDATA)>
<!ATTLIST receiptdateformat
        %lang.att;
>

<!-- B.1.7b Date of receipt of the most recent information (E2B - A.1.7) -->
<!ELEMENT receiptdate		- -	(#PCDATA)>
<!ATTLIST receiptdate
	%lang.att;
>

<!-- B.1.8 Acknowledgment Code for a report -->
<!ELEMENT reportacknowledgmentcode	- -	(#PCDATA)>
<!ATTLIST reportacknowledgmentcode
	%lang.att;
>

<!-- B.1.9 Error Message or Comment -->
<!ELEMENT errormessagecomment	- -	(#PCDATA)>
<!ATTLIST errormessagecomment
	%lang.att;
>
]>