The EudraVigilance Medicinal Product Report Message (EVPRM) allows inserting and maintaining Medicinal Product Information in the Extended EudraVigilance Medicinal Product Dictionary (VEVMPD). The EVPR message header has the same format of the ICHICSR/ADR veterinary message header.The EVPRM report has can contain information regarding Approved Substances as well as Authorised Medicinal Product.Five sections (Organisations, Sources, ATC Code, Administration Route and Pharmaceutical form) allow the user to update five different lookup tables present in the VEVMPD.
The organisation section contains information about Marketing Authorisation Holders and Sponsors that will be stored directly in the new VEVMPD. The sender should use this section to send new data on new Organisations and/or send new information about an Organisation already present in the standard list (e.g. add telephone number or email address)
This section contains information on the bibliographical source of the substance that will be stored directly in the new VEVMPD. The sender should use this section to send new data on sources.
This section contains information regarding Approved Substances. The sender should use this section to send new data on new Approved Substances and/or send new information about an Approved Substance already present in the standard list (e.g. add translation or add alias)
The product section contains all the information regarding one specific Authorised Medicinal Product which is marketed in one country.
The message header section contains the relevant information on the sender,
receiver, the type of information being transmitted and the transmission date.
This is a section header for the message header. This section assumes the
establishment of an EDI trading partnership agreement that will help define the
message number, sender ID, receiver ID, message date.
Message Type
The message type contains information on the type of information being
transmitted. When creating a message, the value of this field should be "EVPRM".
Message Format Version
The message format version contains the version number of the SCHEMA.
Message Format Release
The message format release contains the release number of the message
format version number of the SCHEMA.
Message Number
The message number is a unique tracking number assigned to a specific
product message file transmitted by the sender.
This message number is unique to the sender.
Message Sender Identifier
This field identifies the sender of the message, e.g., company name
identifier or regulatory authority name identifier.
Message Receiver Identifier
This field identifies the intended recipient of the transmission of the message, e.g., company name identifier or regulatory authority name identifier.
The format of the Message Date.
The unique value admitted is "204" corresponding at "CCYYMMDDHHMMSS"
Message Date
The message date is the date on which the message was initiated.
1 = MAH ; 2= Sponsor
The name of the Organisation
The organisation's ev_code. It's mandatory if the operation type is not an insert.
The organisation that send the information.
The Organisation's address
The Organisation's city
The Organisation's state
The Organisation's postcode
The Organisation's country code
The Organisations telephone number
The Organisation's extension telephone number
The Organisation's telephone country code
The Organisation's fax
The Organisation's fax extension
The Organisation's fax country code
The Organisation's email
The type of the operation for this entity.
1 = Insert 2 = Update 4 = Nullify
The Source's Eudravigilance code. It's mandatory if the operation type is not an insert.
The name of the bibliographical source.
The type of the operation for this entity.
1 = Insert 2 = Update 4 = Nullify
The type of the operation for this entity.
1 = Insert 2 = Update 4 = Nullify
The sender should use this section to add or update the translation of the substance name.
The sender should use this section to add or update an alias name of the substance name.
The alias name of the substance name.
The sender should use this section to add or update the translations of an alias name.
The code of the language as reported in the LANGUAGE table in the Simple DB.
The translation of the aliasname.
EV_Code of the Authorised Medicinal Product. It's mandatory if the operation type is not an insert.
Sender Local Code
The format of the Info Date.
The unique value admitted is "102" corresponding at "CCYYMMDD"
Date of the most recent update to the Summary Product Characteristics (SPC). The format is CCYYMMDD
The message date is the date on which the message was initiated.
This section contains information about every formulation in a Medicinal Product. (Some Medicinal Products are several formulations in the same presentation).
This section contains informatin about the SPC Terms of a Medicinal Product, according to differents VEDDRA's versions
The type of the operation for this entity.
1 = Insert 2 = Update 3 = Variation 4 = Nullify 5 = Change Ownership 6 = Withdrawn
This section contains all the information on the product authorisation.
Country code of the country in which the product has been authorised
The procedure the product has followed to be authorised.
The types are:
1 EU Centralised Procedure - Biotechnological Process
2 EU Centralised Procedure - New Active Substances
3 EU Mutual Recognition Procedure
4 EU National Procedure
5 Non EU Procedure
6 EU Centralised Procedure - Orphan Medicinal Products
7 EU decentralised procedure
8 EU Procedure - Article 7 of Directive 2001/82/EC
Marketing authorisation number
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 centralised procedure list A" or "EU centralised procedure list B" this field must be filled with the "EU Number of the product"
Check if the product is an orphan drug.
The format of the WithdrawnDate.
The unique value admitted is "102" corresponding at "CCYYMMDD"
Withdrawn Date of the Medicinal Product. (If Null, the Medicinal Product is in the market).
The message date is the date on which the message was initiated.
This section contains all the information on the product presentation.
The "Full Presentation Name" of the product as it has been authorised
The short name of the product as reported in the "Full Presentation Name".
The generic name as reported in the "Full Presentation Name" (if present)
The name of company/trademark/manufacturer as reported in the "Full Presentation Name" (if present).
The strength and strength unit as reported in the "Full Presentation Name" (if present).
The pharmaceutical form as reported in the "Full Presentation Name" (if present)
This field contains information about the package of the Medicinal Product. In particular, it contaons information about species.
This section contains information about the active ingredients present in the product.
This section contains information about the excipients present in the product.
This element can be used to put some comments in a section. It is mandatory when there is a request of nullification.
The translation of the name.
The code of the language as reported in the LANGUAGE table in the Simple DB. (Official Language Code in the EU).
The code of the concentration type as in the CONCENTRATIONTYPE table in the Access Simple DB
The code of the concentration unit as in the CONCENTRATIONUNIT table in the Access SimpleDB
The concentration of the substance present in the product.
The second concentration of the substance when the user has to specify a range
For an Approved Substance a Source must be specified. The source code must have an attribute: Resolution Mode. Resolution mode = 1 Local (Local Number present in the XML file) Resolution mode = 2 Global (ev_code present in the EudraVigilance Lookup Tables)
1=Local; 2=Global
The MAH code of the Marketing Authorisation Holder as reported in the application of the product. 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 present in the EudraVigilance Lookup Tables)
1=Local; 2=Global
Code of the substance that is present in the product. It identifies univocally a substance. 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 present in the EudraVigilance Lookup Tables)
1=Local Number2=EV_Code
This section contains information about the standard terms: ATC Codes, Pharmaceutical Forms and Administration Routes.
The ATC section contains information about a new ATC Code used in a Medicinal Product (Authorised). It can be maintained too using this section.
2: Proposed Term;3= Standard Term (only EMEA user)
This is the ATCCode
The English Description of a Term
Format of ATC Version Date
Date of last update of ATC Code
1=Insert; 2=Update; 4=Nullify
The Pharmaceutical Form section contains information about a new Pharmaceutical Form used in a Medicinal Product (Authorise). It can be maintained too using this section.
Term, 2: Proposed Term, 3: Standard Term
EV_CODE of the Pharmaceutical Form. It's mandatory if the operation type is not an insert.
The English Description of a Term
For Standard Term this field contains (if exist) the ev_code of the Previous Proposed Term
1=Insert; 2=Update; 4=Nullify
The Administration Route section contains information about a new Administration Route used in a Medicinal Product (Authorised) It can be maintained too using this section.
EV_CODE of Administration Route. It's mandatory if the operation type is not an insert.
The English Description of a Term
Format of Administratiorn Route Date
Date of last update of Administratiorn Route
For Standard Term this field contains (if exist) the ev_code of the Previous Proposed Term
1 Insert; 2=Update; 4=Nullify
Format of the Version Date. Usually ?102? for "CCYYMMDD?
Version Date
This section contains information about the indications of a Medicinal Products
This field says the code of the pharmaceuticalclass that specifies the Drug Indication.
This section contains information about every formulation in a Medicinal Product. (Some Medicinal Products are several formulations in the same presentation).
This XML type is used to indicate, by an empty string, the null value
This XML type is used for specify a non mandatory integer field
This XML type is used for specify a non mandatory double field
The foreign key type: A string of max 60 character.
The CAS Number of the substance (if available).
The English Description of a Term
The Molecular Formula of the substance (if available).
The CBD of substance
The name of the substance. In English.
The ev_code of substance. It's mandatory if the operation type is not an insert.
The Number of entity assigned by the Owner. It's mandatory for Insert.
The codes applied by the sponsors to the substance
2: Proposed Term, 3: Standard Term
The ATC code of the product. The ATC code must have an attribute: Resolution Mode.Resolution mode = 1 Local (ATC Code present in the XML file) Resolution mode = 2 Global (ATC Code present in the EudraVigilance Lookup Tables)
The atccode of the product.
The atccode must have an attribute: Resolution Mode
Resolution mode = 1 Local (Foreign key present in the XML file)
Resolution mode = 2 Global (ev_code present in the Eudravigilance Lookup Tables)
1=Local; 2=Global
This section contains information on the administration route(s) of the product.
1: All relevant Tissues 2: Meat and Offal (including Liver and Kidney and other edible tissues) -- 3: Milk -- 4: Egss --- 5: Meat (includes Muscle and Fat) -- 6: Honey
The Administration Route form of the product. The administration route must have an attribute: Resolution Mode. Resolution mode = 1 Local (Local Number present in the XML file) Resolution mode = 2 Global (ev_code present in the EudraVigilance Lookup Tables)
1=Local Number2=EV_Code
The pharmaceutical form of the product. The pharmaceutical form must have an attribute: Resolution Mode. Resolution mode = 1 Local (Local Number present in the XML file) Resolution mode = 2 Global (ev_code present in the EudraVigilance Lookup Tables)
1=Local Number; 2=EV_Code
This section contains information about the indications of a Medicinal Product, according to different VEDDRA's versions
VEDDRA's version of Drug Indication of a Medicinal Product. (4.0, 5.0, etc)
This field says the level of Drug Indication in the VEDDRA's version.
This field says the code of VEDDRA that specifies the Drug Indication in the VEDDRA's version.
This field indicate the official code which the species is referred with