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POCP_MT030200UV
User
Guidance
This schema is derived from ‘E_ProductEstablishment CMET’:
‘Any organisation that plays a role in the product life-cycle in any
way‘ (ISO/HL7 27953-2).
For ICH ICSR messages, this schema defines the Name of Holder /Applicant
(G.k.3.3).
POCP_MT040100UV
User
Guidance
This schema is derived from ‘A_ProductEvent CMET’ which supports
information on drug manufacturing, transportation, and control with referencing
to ‘R_ProductRelatedAssigned Entity CMET’.
For ICH ICSR messages, the Identification of the Country Where the Drug Was
Obtained (G.k.2.4) is mapped to R_ProductRelatedAssigned Entity CMET and
thus defined by this schema.
POCP_MT050100UV
User
Guidance
This schema is derived from ‘A_ProductInformation CMET’ which supports
information on approval of new drugmarketing and relevant documents.
For ICH ICSR messages, this schema defines Authorisation /Application
Number (G.k.3.1).
POCP_MT081100UV
User
Guidance
This schema is derived from ‘E_SubstanceClinical CMET’ which supports drug
ingredients.
For ICH ICSR messages, this schema defines the Substance /Specified
Substance Identifier and Strength (G.k.2.3.r).
c. Send Response Batch Interaction
Acknowledgement Batch Interaction
MCCI_IN200101UV01
User
Guidance
‘Send a Batch, which groups 0 or more Application level Messages into a Batch
for communication purposes sent as a response to either a Batch, or as a
response to a Message which explicitly requested a Batched response’(ISO/HL7
27953-2).
For Acknowledgement messages, this schema defines root element. The
acknowledgement specialises that of the Transmission by adding structures to
identify the message being acknowledged, and to allow details about the
acknowledgement to be added. This is especially important for reject messages.