The EudraVigilance Medicinal Product Report Message (EVPRM). This version of the Schema reflects version 5.0 of the Business Rules document (Chapter 3.I). This is the root element for the message. Must contain element M.H and at least one of the other child elements of M. Business Rules: M.BR. The message header section must be completed. The section contains information related to sender, receiver, the type of information being transmitted and the transmission date. Contains the data submitted for new/updated organisations to the EVPRM Business Rules: M.Os.BR The organisation section contains information about Marketing Authorisation Holders and Sponsors that will be stored directly in the XEVMPD. The sender should use this section to send data on new Organisations and/or send updated information about an Organisation already present in the standard list (e.g. add/edit telephone number or email address). Business Rules: O.BR. Contains the data submitted for new/updated sources within the EVPRM. Business Rules: M.Ss.BR. The source section contains information about sources of reference information that will be stored directly in the XEVMPD. The sender should use this section to send data on a new source and/or send updated information about a reference source already present in the standard list (e.g. add to the comment). Business Rules: S.BR. Contains the new attachments required by the EVPRM Business Rules: M.ATTs.BR. The document bundled in support of the product message being sent Contains the new/updated PV System Master File Locations within the EVPRM. Business Rules: M.MFs.BR. The development substances section. Contains the new/updated development substances within the EVPRM. Business Rules: M.DSs.BR. This repeatable section is applicable to individual substances that are contained in medicinal products which are NOT yet authorised. For development substances specific confidentiality rules apply. This section shall be used to provide data on a new development substance /or to update information about a development substance for investigational medicinal products. The approved substance section: This section is applicable to all substances that are contained in medicinal product that are authorised. Business Rules: M.ASs.BR. The approved substance section shall be used to specify the name of a substance, which is already in the public domain. This section contains information about the standard terms: ATC Codes, Pharmaceutical Forms and Administration Routes. Business Rules: ST.ATCs.BR. The ATC section contains information about an ATC Code used in a Medicinal Product (Authorised or Development). The ATC container can be used to either; Add a new ATC Code to the XEVMPD, or, to maintain an existing ATC code within the EVMPD Business Rules: ST.PFs.BR The Pharmaceutical Form section contains information about a Pharmaceutical Form used in a Medicinal Product (Authorised or Development). The Pharmaceutical Form container can be used to either; Add a new Pharmaceutical Form to the XEVMPD, or, to maintain an existing Pharmaceutical Form within the EVMPD Business Rules: ST.ARs.BR. The Administration Route section contains information about an Administration Route used in a Medicinal Product (Authorised or Development). The Administration Route container can be used to either; Add a new Administration Route to the XEVMPD, or, to maintain an existing Administration Route within the EVMPD The Development Products section contains all the information regarding Development Medicinal Products that are studied in Clinical Trials. Each Development Product section contains all the information regarding a specific Development Medicinal Product studied in Clinical Trials. Business Rules: M.DPs.BR The Authorised products section contains all the information regarding Authorised Medicinal Products. Business Rules: M.AP.BR. The Authorised product section contains all the information regarding a single Authorised Medicinal Product that is either marketed in one country or throughout the EU following the approval via Central Authorisation Procedures. The message type must be specified. It contains information on the type of information being transmitted. When creating a message, the value of this field must be "XEVPRM". Message Format Version: The message format version shall be specified. It refers to the release number of the message format version of the XSD SCHEMA. Message Format Release The message format release contains the release number of the message format release number of the XSD SCHEMA. Message Number The message number shall be specified. It refers to the unique tracking number assigned to a specific medicinal product report message file transmitted by the sender. The message number is unique to the sender. Message Sender Identifier must be specified. It refers to the unique identifier of the sender organisation as assigned during the EudraVigilance registration process. Business Rules: H.5.BR. Message Receiver Identifier The message receiver identifier shall be specified. This refers to the unique identifier of the receiving organisation i.e. the European Medicines Agency. Business Rules: H.6.BR. The format of the Message Date. The only value accepted is "204" The Message Date must be specified in accordance with the business rules. Business Rules: H.8.BR. The type of organisation shall be specified i.e. marketing authorisation holder (MAH). = 1; Sponsor = 2 The name of the MAH/Sponsor shall be specified. The unique reference for the entity in the message. It's mandatory for Operation Type Insert. Business Rules: O.3.BR. The EVcode of the organisation shall be specified. An EVcode is assigned to every new organisation. Business Rules: O.4.BR. The ID of the organisation that corresponds to the same organisation in the registration system shall be provided. The address of the organisation shall be specified. Business Rules: O.6.BR. The city of the organisation shall be specified. The state of the organisation shall be specified, where applicable. The postcode of the organisation shall be specified. Business Rules: O.9.BR. The country code of the location of the organisation shall be specified. Business Rules: O.10.BR. The telephone number of the organisation shall be specified. The extension telephone number of the organisation shall be specified, where applicable. The telephone country code of the organisation shall be specified. The fax number of the organisation shall be specified, where applicable. The fax number extension of the organisation shall be specified, where applicable. The fax number country code of the organisation shall be specified, where applicable. The email address of the organisation shall be specified, where applicable. Further information on the organisation can be supplied in the comments field, if required. When the organisation operation type is nullification, the comment field is mandatory and the reason for nullification shall be provided. Business Rules O.18.BR The SME status of the Organisation must be specified if the Organisation is an MAH Business Rules: O.19.BR The sme number must be specified if the sme_status is present and not 1 (NA). Business Rules: O.20.BR. The type of the operation for this entity. 1 = Insert 2 = Update 4 = Nullify Busines Rules: O..1.BR. The unique reference for the entity in the message. This field is mandatory for Operation Type Insert. Business Rules: S.1.BR. The EVcode of the reference source shall be specified. An EVcode is assigned to every new reference source. This field is mandatory if the operation type is NOT “Insert”. Business Rules: S.2.BR. The name of the reference source shall be provided. Business Rules: S.3.BR. Further information may be supplied in the comment field. The comment field is mandatory when the operation type is nullification (S..1 = 4). Business Rules S.4.BR. The type of the operation for this entity. 1 = Insert 2 = Update 4 = Nullify Business Rules: S..1.BR. The unique reference for the entity in the message. It's mandatory for Operation Type Insert. Business Rules: MF.1.BR. The EV Code of the entity. Mandatory if the operation type is not insert. Business Rules: MF.2.BR. Further information may be supplied in the comment field. The comment field is mandatory when the operation type is nullification (MF..1 = 4). Business Rules MF.11.BR. The type of the operation for this entity. 1 = Insert 2 = Update 4 = Nullify Business Rules: MF..1.BR The unique reference for the entity in the message. Business Rules: ATT.1.BR. The file name of the attachment with file extension The file type of the attachment. Allowed values are as contained within the restriction allowedfiletypes The name of the attachment given by the sender Type of attachment: Printed Product Information (PPI) = 1 Printed Substance Information (PSI) = 2 The code of the language as reported in the LANGUAGE published list Business Rules: ATT.6.BR. The version of the PPI attachement The date of the last update of the PPI document Business Rules: ATT.8.BR Format of the Version Date. Only accepted value is “102” for "CCYYMMDD” The type of the operation for this entity. The only value accepted is 1 = Insert Business Rules: ATT..1.BR. The unique reference for the entity in the message. It's mandatory for Operation Type Insert. Business Rules: DS.1.BR. The EVcode of the development substance shall be specified. An EVcode is assigned to every new development substance. This field is mandatory if the operation type is NOT “Insert”. Business Rules: D.S.2.BR. Owner Identifier This field identifies the Owner of the Development substance. Only for operation type Insert and reserved for EMA use only. Business Rules DS.3.BR. The code of the sponsor shall be specified. The sponsor code shall have an attribute ‘Resolution Mode’: Resolution mode 1 when the code is a Local Number; this is mandatory if the operation type is “Insert”. Resolution mode 2 when the code is an ev_code; this is mandatory if the operation type is NOT “Insert”. 1 = Local Number ; 2 = EV_Code The Chemical Abstracts Service (CAS) number of the development substance shall be specified, where applicable The empiric molecular formula of the development substance shall be specified, where applicable. This field indicates the code referring to the substance classification look up list The Chemical Biological Description (CBD) of the Development Substance (if applicable) Development substance names section Business Rules: DS.DSNs.BR. The development substance name section shall be used to specify the name and/or code of the development substance. Business Rules: DS.DSN.BR. The name and/or code of the development substance shall be specified in English. Business Rules: DS.DSN.1.BR. Used to specify if the development substance name is a preferred name. 1= Indicates name is the preferred name, 2 Indicates name is not the preferred name. It shall be specified if the development substance name specified is a code. The value is 1 if the name or the code specified is a code; The value is 2 if the name or the code specified is NOT a code. Any internationally recognised code by which the substance can be identified shall be specified as applicable. A valid reference source of the substance code shall be specified. The Source code must have an attribute ‘Resolution Mode’: Business Rules: DS.IC.1.BR Resolution mode = 1 - Local (Local Number present in the XML file in the sources section.) Resolution mode = 2 - Global (EV Code present in the EudraVigilance Lookup Tables) The identifying name/code for the susbstance within the reference source system provided in DS.IC.1. Resolution mode = 1 Local (Local Number present in the XML file) Resolution mode = 2 Global (EV Code present in the EudraVigilance Lookup Tables) Business Rules: DS.SSIs.BR. Business Rules: DS.SSI.BR. For development substances attachments may be absent. Business Rules: DS.ATTs.BR. The attachment section is used to reference an attachment. The referenced attachment may be included as a file in the message or may reference an attachment that is already stored in the EVMPD This field references the printable substance information attachment for this substance. This will be the local number reference number if the attachment is included with the current message otherwise it will be EV Code of the attachement. This element must have an attribute: Resolution Mode. Resolution mode = 1 Local (Local Number present in the XML file). Resolution mode = 2 Global (ev_code of the attachment present in the EudraVigilance Lookup Tables. The pattern of the ev_code is 'ATT999999' Business Rules: DS.ATT.1.BR. The details of the attachment for the approved substance shall be specified. Resolution mode = 1 when the code is a Local Number. Resolution mode 2 when the code is an EV Code. In performing an update of existing medicinal product information where an attachment for an approved substance was already previously loaded and referenced, a confirmation shall be provided that the referenced attachment is the latest version of the documentation. The value is 1 if the attachment is the latest version. Business Rules: DS.ATT.2.BR. Further information on the development substance may be supplied in the comment field. When the development substance shall be nullified, the comment field is mandatory and the reasons for nullification shall be provided. This element can be used to put some comments in a section. It is mandatory when there is a request of nullification. The type of the operation for this entity. 1 = Insert 2 = Update 4 = Nullify 5 = Change Owner (Reserved for EMA) Business Rules: DS..1.BR. Reserved for EMA Use only Business Rules DS..2.BR. The unique reference for the entity in the message. It's mandatory for Operation Type Insert. Buisness Rules: AS.1.BR The EVcode of the approved substance shall be specified. An EVcode is assigned to every new approved substance. This field is mandatory if the operation type is NOT “Insert”. Business Rules: AS.2.BR. A valid reference source of the approved substance name shall be specified The Source code must have an attribute ‘Resolution Mode’ (AS.3..1). Business Rules: AS.3.BR. Resolution mode = 1 when the code is a Local Number this indicates that the reference source is included in the current xml message. Resolution mode = 2 when the code is an EV Code this indicates that the reference is already present in the EVMPD source list. The name of the approved substance in English shall be provided. Business Rules: AS.4.BR. The Chemical Abstracts Service (CAS) number of the approved substance shall be specified, where applicable. The empiric molecular formula of the approved substance shall be specified, where applicable. This field indicates the code referring to the substance classification look up list. A value must be specified from the published list if the operation type is Insert or Update. Business Rules: AS.7.BR. The Chemical Biological Description (CBD) of the Approved Substance (if applicable) The optional substance translations section can be used to supply the names by which the substance is known in languages other than English. Business Rules: AS.Ts.BR. The sender should use this section to add or update each individual translation of the substance name. The two letter code of the language as detailed in the published LANGUAGE list Business Rules: AS.T.1.BR The translation of the substance name must be specified. Business Rules: AS.T.2.BR. The optional substance aliases section can be used to supply known synonyms of the substance name. Business Rules: AS.SAs.BR. Where applicable, one synonym of the substance name shall be provided or updated using this section. A valid reference source of the approved substance synonym shall be specified. The Source code must have an attribute ‘Resolution Mode’ (AS.SA.1..1) Business Rules: AS.SA.1.BR. 1 = Local Number; 2 = EV_Code Resolution mode = 1 Local (Local Number present in the XML file) Resolution mode = 2 Global (EV Code present in the EudraVigilance Lookup Tables for Sources) Business Rules: AS.SA.1..1.BR. The synonym of the substance name shall be specified. This optional section can be used to add or update translations of aliases of the substance name. Business Rules: SA.Ts.BR. The sender should use this section to add or update a translation of an alias name (repeatable if more than one translation exists). The code of the language as reported in the LANGUAGE published list Business Rules: SA.T.1.BR. The translation of the substance alias name shall be specified. Business Rules: SA.T.2.BR. Any internationally recognised code by which the substance can be identified shall be specified as applicable. Business Rules: AS.ICs.BR A valid reference source of the approved substance name shall be specified. The Source code must have an attribute ‘Resolution Mode’ AS.IC.1..1. Business Rules: AS.IC.1.BR Mandatory if the operation type for the substance is "Insert" or Update. Optional for nullifcation operation. Resolution mode = 1 Local (Local Number present in the XML file) Resolution mode = 2 Global (EV Code present in the EudraVigilance Lookup Tables) The identifying name/code for the susbstance within the reference source system provided in AS.IC.1. Resolution mode = 1 Local (Local Number present in the XML file) Resolution mode = 2 Global (EV Code present in the EudraVigilance Lookup Tables) The previous EV Code section This section shall be used when an approved substance shall be linked to the EVcodes of one or more development substances. Business Rules: AS.PEVs.BR. The previous EV Code section This section shall be used when an approved substance shall be linked to the EVcode of a development substance. This field contains an EV Code of the same substance as it exists as a Development Substance in the EVMPD. Business Rules: AS.PEV.1.BR Business Rules: AS.SSIs.BR. Business Rules: AS.ATTs.BR. The attachment section is used to reference an attachment. The referenced attachment may be included as a file in the message or may reference an attachment that is already stored in the EVMPD This field references the attachment for this substance. This element must have an attribute Resolution Mode (AS.ATT.1..1) Business Rules: AS.ATT.1.BR. Resolution mode = 1 Local (Local Number present in the XML file). Resolution mode = 2 Global (EV Code of an attachment already present in the EVMPD). In performing an update of existing medicinal product information where an attachment for an approved substance was already previously loaded and referenced, a confirmation shall be provided that the referenced attachment is the latest version of the documentation. The value is 1 if the attachment is the latest version. Business Rules: AS.ATT.2.BR. Further information may be supplied in the comment field. When the operation type is nullification, the comment field is mandatory and the reason of nullification shall be provided. Business Rules: AS.10.BR. The type of the operation for this entity. 1 = Insert 2 = Update 4 = Nullify Business Rules: AS..1.BR Reserved for EMA Use only Business Rules AS..2.BR. 1: Development Term, 2: Proposed Term;3= Standard Term (EMA USE ONLY) Business Rules: ATC.1.BR. This is the ATC Code Business Rules: ATC.2.BR. This field identifies the Owner of the Development Entity. Only for operation type Insert and reserved for EMA use only. Business Rules: ATC.3.BR. The English Description of the Term Business Rules: ATC.4.BR. Format of the Version Date. Only accepted value is “102” for "CCYYMMDD” Date of last update of ATC Code This element can be used to put some comments in a section. It is mandatory when there is a request of nullification. Business Rules: ATC.7.BR. 1=Insert; 2=Update; 4=Nullify Business Rules: ST.ATC..1.BR. 1: Development Term, 2: Proposed Term;3= Standard Term (EMA USE ONLY) Business Rules: ST.PF.1.BR. The unique reference for the entity in the message. It's mandatory for Operation Type Insert. Business Rules: ST.PF.2.BR. EV_CODE of the Pharmaceutical Form. It's mandatory if the operation type is not an insert. Business Rules: ST.PF.3.BR. This field identifies the Owner of the Development Entity. Only for operation type Insert and reserved for EMA Use only. Business Rules: ST.PF.4.BR. The English Description of a Term Business Rules: ST.PF.5.BR. Format of the Version Date. Only accepted value is “102” for "CCYYMMDD” For Development Term, this field is empty. For Proposed Term this field contains (if exist) the ev_code of the Previous Development Term. For Standard Term this field contains (if exist) the ev_code of the Previous Proposed Term. Business Rules: ST.PF.8.BR. This element can be used to put some comments in a section. It is mandatory when there is a request of nullification. Business Rules: ST.PF.9.BR 1=Insert; 2=Update; 4=Nullify Business Rules: ST.PF..1 1: Development Term, 2: Proposed Term;3= Standard Term (EMA USE ONLY) Business Rules: ST.AR.1.BR. The unique reference for the entity in the message. It's mandatory for Operation Type Insert. Business Rules: ST.AR.2.BR. EV_CODE of Administration Route. It's mandatory if the operation type is not an insert. Business Rules: ST.AR.3.BR. Owner Identifier: This field identifies the Owner of a Development Entity. Reserved for EMA use only. Business Rules: ST.AR.4.BR. The English Description of a Term Business Rules: ST.AR.5.BR. Format of the Version Date. Only accepted value is “102” for "CCYYMMDD” Date of last update of Administratiorn Route For Development Term, this field is empty. For Proposed Term this field contains (if exist) the ev_code of the Previous Development Term. For Standard Term this field contains (if exist) the ev_code of the Previous Proposed Term Business Rules: ST.AR.8.BR. This element can be used to put some comments in a section. It is mandatory when there is a request of nullification. Business Rules: ST.AR.9.BR. 1:Insert; 2=Update; 4=Nullify Business Rules: ST.AR..1.BR. The unique reference for the entity in the message. It's mandatory for Operation Type Insert. Business Rules: DP.1.BR EV_CODE of Development Product. It's mandatory if the operation type is NOT an insert. Business Rules: DP.2.BR This field identifies the Owner of the Development Entity. Only for operation type Insert and reserved for EMA use only. Business Rules: DP.3.BR Sender Local Code The code of the sponsor shall be specified. The sponsor code shall have an attribute ‘Resolution Mode’: Resolution mode 1 when the code is a Local Number (organisation is present in the current message) Resolution mode 2 when the code is an EV Code where the organisation is already present in the EVMPD Business Rules: DP.5.BR. 1 = Local Number ; 2 = EV_Code This section contains all the information on the product presentation. The code of the development product if available. Business Rules: DP.6.1.BR. The name of the development product if available. Business Rules: DP.6.2.BR. Other descriptive name. Business Rules: DP.6.3.BR. This section contains information on the ATC code(s) for the product. Business Rules: DP.ATCs.BR This section contains information on the ATC code(s) for the product. Business Rules: DP.ATCs.BR The ATC code of the product. The ATC code must have an attribute: Resolution Mode. Business Rules DP.ATC.1.BR. Resolution mode = 1 Local (Foreign key present in the XML file) Resolution mode = 2 Global (EV Code present in the Eudravigilance Lookup Tables) This section contains information about the indications of a Medicinal Product, according to different MEDDRA's versions. Business Rules: DP.Inds.BR. This section contains information about the indications of a Medicinal Product, according to different MEDDRA's versions The MedDRA's version that the Drug Indication MedDRA code refers to (13.0, 13.1, 14.0 etc). Business Rules: DP.Ind.1.BR. This field indicates the level of Drug Indication in the MEDDRA's version. This field indicates the MEDDRA code that specifies the Drug Indication as defined in the referenced MEDDRA version. Business Rules: DP.Ind.3_BR. This section contains information about every formulation in a Medicinal Product. (Some Medicinal Products are several formulations in the same presentation). This section contains information about each formulation in a Medicinal Product. The Printed Product Information document in a specific language for the product either bundled along with the product message or referring to an existing document within EVMPD. The PPI must contain various annexes relating to the product This field references the attachment for this product. This will be local reference number relevant to sender organisation if it is an insert operation, otherwise it will be ev code of the attachement. This element must have an attribute: Resolution Mode.Resolution mode = 1 Local (Local Number present in the XML file) Resolution mode = 2 Global (ev_code of the attachment present in the EudraVigilance Lookup Tables. The pattern of the ev_code is 'ATT999999' ) 1=Local Number2=EV_Code Issue: DCM version says;The details of the attachment for the approved substance shall be specified. • Resolution mode 1 when the code is a Local Number; this is mandatory if the operation type is NOT “Insert”. • Resolution mode 2 when the code is an ev_code; this is mandatory if the operation type is NOT “Insert”. Suggested IT version; The resolution mode is 1 if a new attachment is included in the message and this is to be used or 2 if the reference is an existing EV_Code This must be set to 1 if an updated product PPI references a PPI previously loaded in the EVMPD (references a remote look up value). This element can be used to put some comments in a section. It is mandatory when there is a request of nullification Business Rules: DP.7.BR The type of the operation for this entity. 1 = Insert 2 = Update 4 = Nullify 5 = Change Ownership (EMA USE ONLY) Business Rules: DP..1.BR The unique reference for the entity in the message. It's mandatory for Operation Type Insert. Business Rules: AP.1.BR EV_Code of the Authorised Medicinal Product. It's mandatory if the operation type is NOT an insert. Business Rules: AP.2.BR. This field identifies the new Owner of the Authorised Product. The field is reserved for EMA use only Business Rules: AP.3.BR. The MAH code of the Marketing Authorisation Holder as reported in the application of the product. This element must have an attribute: Resolution Mode. Business Rules: AP.4.BR Resolution mode = 1 Local (Local Number present in the XML file). Resolution mode = 2 Global (ev_code present in the EudraVigilance Lookup Tables) The EV Registration System QPPV code assigned to the QPPV detailed in the Pharmacovigilance System Master File in place for the product. Format of this code is whole number maximum 10 digits Business Rules: AP.5.BR. The code of the PharmacoVigilance System Master File Location. Must have an attribute; resolutionmode. Business Rules: AP.6.BR. Resolution mode = 1 Local (Local Number present in the XML file). Resolution mode = 2 Global (ev_code present in the EudraVigilance Lookup Tables) - The format of stored master files location codes is MFLxxxxxx. The Pharmacovigilance Enquiry email address shall be specified. Business Rules: AP.7.BR The Pharmacovigilance Enquiry telephone number shall be specified. Business Rules: AP.8.BR. Sender Local Code The format of the Info Date. The only value accepted is "102" corresponding to "CCYYMMDD" Business Rules: AP.10.BR. Date of the most recent update to the Summary Product Characteristics (SPC). The format must conform to "CCYYMMDD" Business Rules: AP.11.BR. This section contains all the information on the product authorisation. Country code of the country in which the product has been authorised Business Rules: AP.12.1.BR The procedure the product has followed to be authorised. Must be the code specified in the published list Business Rules: AP.12.2.BR Marketing authorisation status must be a value from the published list Business Rules: AP.12.3.BR. Marketing authorisation number Business Rules: AP.12.4.BR. Marketing authorisation Date Business Rules: AP.12.5.BR. Marketing authorisation Date Format must be either "102" corresponding to "CCYYMMDD" or "610" corresponding to "CCYYMM" Business Rules: AP.12.6.BR. If the authorisation procedure is "EU mutual recognition procedure" this field must be filled with the Mutual Recognition Procedure Number of the product. If the authorisation procedure is "EU decentralised procedure" this field must be filled with the EU Decentralised procedure number of the product. Business Rules: AP.12.7.BR If the authorisation procedure is one of the EU centralised procedures (CAPs) this field must be filled with the "EU Number of the product" Business Rules: AP.12.8.BR. The legal basis of the authorisation must be a value from the published list Business Rules: AP.12.13.BR. This section contains information about all medicinal product types that apply to the authorised product Business Rules: AP.12.MPTs.BR. This section contains information about each medicinal product types that apply to the authorised product This field contains the code that specifies the medicinal product type Business Rules: AP.12.MPT.1.BR. Value 1 indicates that the product is an orphan drug. Indicates if the product is the subject of Intensive Monitoring. A value of 1 indicates that the product is subject to intensive monitoring. A value of 2 indicates that the product is NOT subject to intensive monitoring. Business Rules: AP.12.10.BR The format of the date of invalidating the MA. The only value accepted is "102" corresponding at "CCYYMMDD" Business Rules: AP.12.12.BR Date from which the MA is invalidated. Business Rules: AP.12.12.BR This section contains all the information on the product presentation. The "Full Presentation Name" of the product as it has been authorised. Business Rules: AP.13.1.BR The short name of the product as reported in the "Full Presentation Name". Business Rules: AP.13.2.BR. The generic name (if present) as part of the "Full Presentation Name". Business Rules: AP.13.3.BR. The name of company/trademark/manufacturer (if present) as part of the "Full Presentation Name". Business Rules: AP.13.4.BR. The strength and strength unit (if present) as part of the "Full Presentation Name". Business Rules: AP.13.5.BR. The pharmaceutical form (if present) as part of the "Full Presentation Name". Business Rules: AP.13.6.BR. This field contains information about the package of the Medicinal Product. It is Mandatory when operation type is NOT a nullification Business Rules: AP.13.7.BR This section contains the pharmaceutical forms of the product as authorised. Business Rules: AP.APFs.BR. This section contains information for each pharmaceutical form of the product as authorised. The authorised pharmaceutical form of the product. Must have an attribute: Resolution Mode. Business Rules: AP.APF.1.BR. Resolution mode = 1 Local (Local Number present in the XML file) Resolution mode = 2 Global (ev_code present in the EudraVigilance Lookup Tables) This section contains information on the ATC code(s) approved for the product. Business Rules: AT.ATCs.BR The ATC code of the product. The ATC code must have an attribute: Resolution Mode. Business Rules: AP.ATC.1.BR. Resolution mode = 1 Local (Foreign key present in the XML file) Resolution mode = 2 Global (ev_code present in the Eudravigilance Lookup Tables) This section contains information about all of the indications of a Medicinal Product, according to different MEDDRA's versions. Business Rules: AP.INDs.BR. This section contains information about each indication of a Medicinal Product, according to different MEDDRA's versions The MedDRA's version that the Drug Indication MedDRA code refers to (e.g. 13.0, 13.1, 14.0 etc) Business Rules: AP.IND.1.BR. This field says the level of Drug Indication in the MEDDRA's version. This field details the code of MEDDRA that specifies the Drug Indication in the MEDDRA's version. Business Rules: AP.IND.3.BR. This section contains information about every formulation in a Medicinal Product. (Some Medicinal Products are several formulations in the same presentation). This section is used to reference all development products that are the same as the approved product. Business Rules: AP.PEVs.BR. This field contains (if exist) the ev_code of the previous development product it refers to. Business Rules: AP.PEV.1.BR. Container for the Printed Product Information documents for the product. Business Rules: AP.PPIs.BR. Contains details for each individual Printed Product Information document in a specific language for the product. Each PPI must contain various annexes relating to the product. This field references the attachment for this product. This element must have an attribute: Resolution Mode. Business Rules: AP.PPI.1.BR Resolution mode = 1 Local (Local Number present in the XML file). Resolution mode = 2 Global (ev_code of the attachment present in the EudraVigilance Lookup Tables. The pattern of the ev_code is 'ATT999999' ) This must be set to 1 (valid) if an updated product PPI references a PPI previously loaded in the EVMPD (AP.PPI.1..1 = 2). Business Rules: AP.PPI.2.BR. This element can be used to put some comments in a section. Business Rules: AP.14.BR. The type of the operation for this entity. 1 = Insert 2 = Update [ 3 = Variation - Removed 16/6/2014 ] 4 = Nullify 5 = Change Ownership (EMA USE ONLY) 6 = Invalidate MA Business Rules: AP..1.BR The pharmaceutical form of the product. The pharmaceutical form must have an attribute: Resolution Mode. Business Rules: AllProducts.PP.1.BR.1 Business Rules: AuthProducts.PP.1.BR.1 Resolution mode = 1 Local (Local Number present in the XML file) Resolution mode = 2 Global (ev_code present in the EudraVigilance Lookup Tables) This section contains information on all of the administration route(s) of the product. Business Rules: AllProducts.PP.ARs.BR. This section contains information each administration route of the product. The Administration Route form of the product. The administration route must have an attribute: Resolution Mode. Business Rules: AllProducts.PP.AR.1.BR. Business Rules: AuthProducts.PP.AR.1.BR. Resolution mode = 1 Local (Local Number present in the XML file) Resolution mode = 2 Global (ev_code present in the EudraVigilance Lookup Tables) This section contains information about all of the active ingredients present in the product. Business Rules: AllProducts.PP.ACTs.BR. This section contains information about an individual active ingredient present in the product. The reference code of the substance that is present in the product. It identifies unequivocally a substance. This element must have an attribute: Resolution Mode. Business Rules: DevProducts.PP.ACT.1.BR. Business Rules: AuthProducts.PP.ACT.1.BR Resolution mode = 1 Local (Local Number present in the XML file) Resolution mode = 2 Global (ev_code present in the EudraVigilance Lookup Tables) The code of the concentration type as in the CONCENTRATIONTYPE from the published list. Business Rules: AllProducts.PP.ACT.2.BR. The Low limit numerator value or for non range measurements the numerator value. The Low limit numerator prefix or for non range measurements the numerator prefix. Must be a value from the published list. Business Rules: AllProducts.PP.ACT.4.BR. The Low limit numerator Unit or for non range measurements the numerator Unit. Must be a value from the published list. Business Rules: AllProducts.PP.ACT.5.BR. The Low limit denominator value or for non range measurements the value specified. The Low limit denominator prefix or for non range measurements the denominator prefix. Business Rules: AllProducts.PP.ACT.7.BR. The Low limit denominator Unit must be a value from the published list. Business Rules: AllProducts.PP.ACT.8.BR. The High limit numerator value must ONLY be used when specifying a range. Business Rules: AllProducts.PP.ACT.9.BR. The High limit numerator prefix is used when specifying a range and must be from the published list. Business Rules: AllProducts.PP.ACT.10.BR. The High limit numerator Unit is used when specifying a range and must be from the published list. Business Rules: AllProducts.PP.ACT.11.BR. The High limit denominator Value is used when specifying a range. Business Rules: AllProducts.PP.ACT.12.BR. The High limit denominator prefix is used when specifying a range and must be from the published prefix list. Business Rules: AllProducts.PP.ACT.13.BR. The High limit denominator Unit is used when specifying a range and must be from the published denominator unit list. Business Rules: AllProducts.PP.ACT.14.BR. This section contains information about the excipients present in the product. Business Rules: AllProducts.PP.EXCs.BR. This section contains information about the excipients present in the product. Code of the substance that is present in the product. It identifies unequivocally a substance that is acting as an excipient in this pharmaceutical product. This element must have an attribute: Resolution Mode. Business Rules: DevProducts.PP.EXC.1.BR. Business Rules: AuthProducts.PP.EXC.1.BR Resolution mode = 1 Local (Local Number present in the XML file) Resolution mode = 2 Global (ev_code present in the EudraVigilance Lookup Tables) The code of the concentration type as in the CONCENTRATIONTYPE from the published list. Business Rules: AllProducts.PP.EXC.2.BR. The Low limit numerator value or for non range measurements the numerator value. Business Rules: AllProducts.PP.EXC.3.BR. The Low limit numerator prefix or for non range measurements the numerator prefix. Business Rules: AllProducts.PP.EXC.4.BR. The Low limit numerator Unit or for non range measurements the numerator Unit. Must be a value from the published list. Business Rules: AllProducts.PP.EXC.5.BR. The Low limit denominator value or for non range measurements the denominator value. Business Rules: AllProducts.PP.EXC.6.BR. The Low limit denominator prefix or for non range measurements the denominator prefix. Must be a value from the published list. Business Rules: AllProducts.PP.EXC.7.BR. The Low limit denominator Unit or for non range measurements the denominator Unit. Must be a value from the published list. Business Rules: AllProducts.PP.EXC.8.BR. The High limit numerator value must ONLY be used when specifying a range. Business Rules: AllProducts.PP.EXC.9.BR. The High limit numerator prefix is used when specifying a range and must be from the published list. Business Rules: AllProducts.PP.EXC.10.BR. The High limit numerator Unit is used when specifying a range and must be from the published list. Business Rules: AllProducts.PP.EXC.11.BR. The High limit denominator Value is used when specifying a range. Business Rules: AllProducts.PP.EXC.12.BR. The High limit denominator prefix is used when specifying a range and must be from the published list. Business Rules: AllProducts.PP.EXC.13.BR. The High limit denominator Unit is used when specifying a range and must be from the published list. Business Rules: AllProducts.PP.EXC.14.BR. This section contains information about all of the adjuvant ingredients present in the product. Business Rules: AllProducts.PP.ADJs.BR. This section contains information about an individual adjuvant present in the product. The reference code of the substance that is present in the product. It identifies unequivocally a substance. This element must have an attribute: Resolution Mode. Business Rules: DevProducts.PP.ADJ.1.BR. Business Rules: AuthProducts.PP.ADJ.1.BR Resolution mode = 1 Local (Local Number present in the XML file) Resolution mode = 2 Global (ev_code present in the EudraVigilance Lookup Tables) The code of the concentration type as in the CONCENTRATIONTYPE from the published list. Business Rules: AllProducts.PP.ADJ.2.BR. The Low limit numerator value or for non range measurements the numerator value. The Low limit numerator prefix or for non range measurements the numerator prefix. Must be a value from the published list. Business Rules: AllProducts.PP.ADJ.4.BR. The Low limit numerator Unit or for non range measurements the numerator Unit. Must be a value from the published list. Business Rules: AllProducts.PP.ADJ.5.BR. The Low limit denominator value or for non range measurements the value specified. The Low limit denominator prefix or for non range measurements the denominator prefix. Business Rules: AllProducts.PP.ADJ.7.BR. The Low limit denominator Unit must be a value from the published list. Business Rules: AllProducts.PP.ADJ.8.BR. The High limit numerator value must ONLY be used when specifying a range. Business Rules: AllProducts.PP.ACT.9.BR. The High limit numerator prefix is used when specifying a range and must be from the published list. Business Rules: AllProducts.PP.ADJ.10.BR. The High limit numerator Unit is used when specifying a range and must be from the published list. Business Rules: AllProducts.PP.ADJ.11.BR. The High limit denominator Value is used when specifying a range. Business Rules: AllProducts.PP.ADJ.12.BR. The High limit denominator prefix is used when specifying a range and must be from the published prefix list. Business Rules: AllProducts.PP.ADJ.13.BR. The High limit denominator Unit is used when specifying a range and must be from the published denominator unit list. Business Rules: AllProducts.PP.ADJ.14.BR. This section contains information about all of the medical devices present in the product. Business Rules: AllProducts.PP.MDs.BR. This section contains the code of each medical device present in the product. Business Rules: AllProducts.PP.MD.1.BR. This XML type is used to indicate, by an empty string, the null value This XML type is used for specify a non mandatory double field The ev_code type: A string of max 60 character. The foreign key type: A string of max 60 character. The foreign key / text type: A string of max 2000 character which can be a foreign key or a text.