Products Management Services (PMS) - Implementation Of .
11 February 2020EMA/676106/2019Information ManagementProducts Management Services (PMS) - Implementationof International Organization for Standardization (ISO)standards for the identification of medicinal products(IDMP) in EuropeChapter 7 : XEVMPD - PMS Migration guideVersion 1Official address Domenico Scarlattilaan 6 1083 HS Amsterdam The NetherlandsAddress for visits and deliveries Refer to www.ema.europa.eu/how-to-find-usSend us a question Go to www.ema.europa.eu/contactTelephone 31 (0)88 781 6000An agency of the European Union European Medicines Agency, 2020. Reproduction is authorised provided the source is acknowledged.
Table of contentsIntroduction . 3Migration of Article 57 data into IDMP/SPOR format and terminology . 31.1. Scope and strategy . 41.1.1. Full data migration (i.e. initial load) . 41.1.2. Delta data import . 51.1.3. Feedback loop. 51.1.4. Terminology mastering and migration . 61.1.5. Version and conflicts management. 61.2. Mapping and migration rules. 71.2.1. Authorised medicinal product subject area . 81.2.2. Marketing authorisation subject area . 221.2.3. Organisation subject area . 261.2.4. Clinical Particulars subject area . 281.2.5. Packaged Medicinal Product subject area . 291.2.6. Pharmaceutical Product subject area . 311.2.7. Active Pharmaceutical Product subject area. 331.2.8. Ingredient subject area . 43Products Management Services (PMS) - Implementation of International Organization forStandardization (ISO) standards for the identification of medicinal products (IDMP) inEuropeEMA/676106/2019Page 2/43
IntroductionMigration of Article 57 data into IDMP/SPOR format andterminologyThe EMA intends to migrate the data held in the eXtended Eudravigilance Medicinal Product Dictionary(XEVMPD) and submitted by marketing authorisation holders (MAHs) under the Art.57 (2) legalobligations since 2012, into the ISO IDMP-compliant data format and terminologies. The transformeddata will be loaded into the PMS hub. This approach is expected to: allow building of the new ISO IDMP compatible repository [i.e. Product Management Services(PMS)] from the data submitted since 2012 under the Art.57 legal obligation; provide external stakeholders with services (i.e. API) for the access and retrieval of their own datapreviously submitted in Art.57 data format [i.e. via the eXtended Surveillance Medicinal ProductReport message (XEVPRM)] transformed and remapped into the new data format andterminologies for further validation and enrichments; facilitate business continuity ensuring that PMS contains data comparable with what is available inthe Article 57 database and currently supports the EMA business and regulatory processes untilintegration with PMS will be implemented; facilitate transparency and comprehension of the data transformed into the new format bystakeholders and owner of the data.This section provides information on the approach followed by the European Medicines Agency (EMA)to enable the transformation and migration of the Art.57 data held in the XEVMPD into the ISO IDMPcompliant data format and terminologies which will reside in the PMS hub. Specifically, this chapter isaimed at describing the following aspects:1. what data from Art.57 database is migrated into PMS hub;2. description of the technical strategy and solutions adopted for the forward transformation andmigration of the data from Art.57 database into PMS as well as the so-called 'feedback loop'; i.e.once the data is modified in PMS, the transformation and synchronisation of the affected data backin the Art.57 database;3. the Art.57-PMS data mapping, including the transformation rules that will be applied to the dataduring the forward migration from Art.57 database into PMS and in the feedback loop.This chapter is purely for information only and for transparency, it does not require or oblige individualstakeholders to implement this approach in their in-house systems. The mapping and migration rulesprovided are based on the XEVMPD and PMS logical data model which may be different from theindividual stakeholder database architecture and it is beyond EMA remit to advice stakeholders on howto migrate the data recorded in their internal system to fulfil new legal requirements. However, theAgency is committed to share its own strategy and experience and encourages the stakeholders toreflect and transpose the transformation rules provided in section 1.2. Mapping and migration rules intheir in-house system when transforming Article 57 data into IDMP-compatible format.The migrated data can be exported and accessed via the API as specified in Chapter 5 and 6 of thisGuidance.Products Management Services (PMS) - Implementation of International Organization forStandardization (ISO) standards for the identification of medicinal products (IDMP) inEuropeEMA/676106/2019Page 3/43
1.1. Scope and strategyThe strategy to migrate the data into PMS and the feedback loop is described in this section andoutlined in Figure 1.Figure 1The data is migrated from XEVMPD into PMS (i.e. as a database to database migration) and a feedbackloop process is synchronising the data from PMS into XEVMPD via XEVPRM messages. The data ismigrated from XEVMPD into PMS in two stages: full data migration, that allows the initial load of the data from XEVMPD into PMS; andsubsequently delta import, that allows the periodic synchronisation from XEVMPD into PMS system with thenewly received data.1.1.1. Full data migration (i.e. initial load)As part of the full data migration (i.e. initial load), all versions of all authorised human products aremigrated from the XEVMPD into PMS; this includes all historical versions of the XEVMPD productsindependently from: the marketing authorisation status (i.e. including withdrawn, superseded); the country of authorisation (i.e. non-EU products provided in the database on volunteer basis oras necessary for pharmacovigilance activities); the sender of the product (i.e. including all so-called 'XEVMPD Legacy Products' as maintained byEMA); the status of the product (i.e. including nullified products).NOTE: Development products available in the XEVMPD are not migrated in the initial load the as partof this phase of the project.Products Management Services (PMS) - Implementation of International Organization forStandardization (ISO) standards for the identification of medicinal products (IDMP) inEuropeEMA/676106/2019Page 4/43
The outline of the full data migration process is as follows:1. A preparatory step occurs, where relevant underlying terminology is migrated and mastered in theReferentials Management Services (RMS), Organisation Management Services (OMS) andSubstance Management Services (SMS) as applicable and with the appropriate cross references tothe XEVMPD (EV Codes). Hence the EV Codes of the XEVMPD terminologies are loaded into astaging area where the EV Codes are transformed into the relevant RMS, OMS, SMS codes andterms.2. Subsequently, the XEVMPD data is transformed into IDMP compatible format based on the PMSLogical Data Model (LDM) and according to the mapping rules described in section 1.2. Mappingand migration rules of this document when loading into PMS.1.1.2. Delta data importAs part of the delta import, from XEVMPD into PMS all versions of new products created in the XEVMPDand all versions of products which have been amended in the XEVMPD since the last synchronisationare migrated to PMS. Vice versa, the feedback loop process takes place when migrating the data fromPMS into the XEVMPD. During feedback loop process, all versions of new products created in PMS andall versions of products which have been amended in PMS since the last synchronisation are migratedto the XEVMPD.The outline of the delta import process is as follows:1. A delta detection process runs every hour and loads XEVMPD changes into PMS based on the sameprocess of the full data migration process described in section 1.1.1. Full data migration (i.e. initialload). 1.1.1.2. The XEVMPD synchronises with PMS by identifying, extracting and synchronising the changesreceived in the XEVMPD since the last delta import. Any data changes that occur in RMS, OMS,SMS are evaluated (in real time) for relevance to the XEVMPD and, where appropriate, substance,referentials and organisation data changes are propagated to the XEVMPD via XEVPRM, with theappropriate EV Code.NOTE: Product versions created in the XEVMPD by a synchronisation from PMS are not synchronised toPMS again.1.1.3. Feedback loopThe feedback loop process is synchronising the data from PMS into XEVMPD via XEVPRM messages.At an agreed schedule, the changes received in the PMS hub are codified with the appropriate EV Codeand propagated to XEVMPD via XEVPRM.NOTE 1: a version management system is in place whereby any XEVPRM generated from PMS thatdoes not refer to the latest version of the product as available in the XEVMPD will be rejected by theXEVMPD parser. This is to ensure that information received directly in the XEVMPD (e.g. by externalstakeholders via Art.57 submission) is never overwritten by the synchronisation from PMS (i.e. duringthe transition period). Further details of the version management system are described in section1.1.5. Version and conflicts management.Products Management Services (PMS) - Implementation of International Organization forStandardization (ISO) standards for the identification of medicinal products (IDMP) inEuropeEMA/676106/2019Page 5/43
1.1.4. Terminology mastering and migrationAt the time of the migration and transformation of the Art.57 data into PMS all XEVMPD data based onthe controlled vocabularies (CVs) will be mapped and recoded against the terminology available inRMS, OMS and SMS respectively and as applicable. When the information is pushed back from PMShub into XEVMPD via the feedback loop, the information based on RMS, OMS and SMS terminologieswill be codified back into the relevant XEVMPD CV terms.In order to maintain data integrity, the following load order must be maintained when loading to MDM:a.Reference data;b.Organisation data;c.Substance data;d.Product data;e.Deprecation (Substance, Product, Organisation or Reference data transaction).The table below highlights the relationship between each domain (columns) and its dependencies(rows):SSPORXPORXXXX1.1.5. Version and conflicts managementAs each target system has a different route for data updates outside of the feedback loop (i.e. PMS viamanual entry in the EMA Data Stewardship UI and XEVPMD via XML messages), data update conflictsmay arise during migration and feedback loop synchronisation. Such conflicts are resolved by theXEVMPD being the overriding source of information. The versions in XEVMPD and in PMS may divergeat a given point in time and prior to the resolution of the conflicts.Conflicts are defined based on business requirements or where products were updated via messages inXEVMPD, but an update also occurred in PMS between the XEVPRM message timestamp and the timewhen the update was propagated to PMS (i.e. when in PMS an update occurred on an outdated versionof the product).In this situation, any XEVPRM generated from PMS that does not refer to the latest version of theproduct as available in the XEVMPD will be rejected by the XEVMPD parser. This is to ensure thatinformation received directly in the XEVMPD (e.g. by external stakeholders via Art.57 submission) isnever overwritten by the synchronisation from PMS (i.e. during the transition period). This solutionimplies the following:Products Management Services (PMS) - Implementation of International Organization forStandardization (ISO) standards for the identification of medicinal products (IDMP) inEuropeEMA/676106/2019Page 6/43
Versions of a product within PMS contain a reference to the revision number in XEVMPD that theyrefer to. This is populated through the ETL (Extract-Transform-Load) and through the processing ofthe acknowledgement (ACK) messages. Once a product is changed in PMS, the message sent to XEVMPD contains a reference to theXEVMPD revision number that the change is based on. PMS will obtain this from the versions of theproduct. XEVMPD verifies, upon reception of the message, if the revision number is still the latest, in whichcase it will proceed normally (i.e. positive ACK should no other conflicts arise), or if there is a morecurrent revision, in which case the message shall be rejected (i.e. generating a negative ACK). PMS will process ACK (including Negative ACK messages) and, in case a positive ACK is received,the PMS version is linked with the specified XEVMPD revision number (as parsed from the ACKmessage).1.2. Mapping and migration rulesThis section describes the data elements available in the Article 57 database and the data fields in PMSto which this data will be migrated (as applicable).As outlined in section 1.1. Scope and strategy, the migration of the data from Art.57 database intoPMS hub is performed via a database to database data migration. Hence the description of the rulesapplicable for backwards and forward transformations, are presented listing the concerned dataelements of the applicable subject areas, within the PMS LDM and as per Figure 2 below:Products Management Services (PMS) - Implementation of International Organization forStandardization (ISO) standards for the identification of medicinal products (IDMP) inEuropeEMA/676106/2019Page 7/43
Figure 21.2.1. Authorised medicinal product subject area1.2.1.1. Medicinal ProductPMS defines medicinal products (for the purpose of the PMS database) in accordance to attributesCountry, Active substance (or group of active substances contained in the same medicinal product),Pharmaceutical form, Medicinal product strength and Product name (including all different namesassociated to the same global marketing authorisation).In some member states, Marketing Authorisation Numbers for Nationally Authorised Products (NAPs)are assigned at Packaged Medicinal Product level; this is also the case for Centrally AuthorisedProducts (CAPS). In addition, translations of the medicinal product name for medicinal productscovered by the same marketing authorisation (MA) number are considered to be the same medicinalproduct name in PMS. In both cases, these types of products are listed as separate products inXEVMPD. Grouping of these separate products in XEVMPD under a single product entity in PMS willtake place during the enrichment process and will be further analysed during the project’s migrationdesign.The elements highlighted in red in Figure 3and table below summarise the information that is mappedto Article 57 data and that are subject to transformation, migration and feedback loop.Products Management Services (PMS) - Implementation of International Organization forStandardization (ISO) standards for the identification of medicinal products (IDMP) inEuropeEMA/676106/2019Page 8/43
Figure 3The transformation and feedback loop rules apply as follows:PMSXEVMPD/Data ElementXEVPRM DataMigration to PMS RuleFeedback loop inArt.57 ruleelementCombinedAuthorisedCombined PharmaceuticalIf a combinedPharmaceuticalpharmaceuticalForm is a subset of the dosepharmaceutical form isDose Form Term IDform (AP.APF.1)forms reported in Art.57available in PMS, theauthorised pharma formapplicable and recoded(AP.APF.1).value will populate theThe ETL will apply thefollowing rule:If AP.APF.1 is categorised inthe EDQM pharmaceuticalform list available in RMS as acombined Form, then theProducts Management Services (PMS) - Implementation of International Organization forStandardization (ISO) standards for the identification of medicinal products (IDMP) inEuropeEMA/676106/2019Art.57 AuthorisedPharma Form with thisvalue (AP.APF.1).Alternatively, if thisvalue is not availablein PMS, the ETL willPage 9/43
PMSXEVMPD/Data ElementXEVPRM DataMigration to PMS RuleFeedback loop inArt.57 ruleelementapplicable RMS ID will be usedselect the appropriateto populate the CombinedManufacturedPharmaceutical Dose Formpharmaceutical formsTerm ID.in PMS and willIf AP.APF.1 is not categorisedpopulate its AP.APF.1.in the EDQM pharmaceuticalform list available in RMS as acombined form, then then theCombined PharmaceuticalDose Form Term ID will beempty.As this field is repeatable inthe Art.57 database, themigration will occur only ifthere is ONE reportedAuthorised PharmaceuticalForm in Art.57.Orphan DesignationOrphan DrugStatusStatus (AP.12.9)Paediatric Use flagComment (AP.14)Direct 1:1 migration.NOTE: In PMS the values areNOTE: the PMS valuesBoolean: the Boolean valuefrom the RMS CV willwill be mapped to thebe transformed intoapplicable RMS Values (i.e. Y the applicable BooleanValid and N Leave empty)value.The information within theIf the flag is selected incomment field (AP.14) will bePMS, a string with theparsed:text 'Medicinal product'Medicinal product authorisedfor the treatment in children'than the flag is turned on inPMS.Legal basisDirect 1:1 migration.(AP.12.13)AdditionalIntensivemonitoring Flagmonitoringloop.CV, whilst in XEVMPD they areIf comment AP.14 test:Legal Basis Term IDDirect 1:1 feedbackauthorised for thetreatment in children'will be appended inAP.14 n XEVPRM,unless it is alreadypresent.Direct 1:1 feedbackloop.Direct 1:1 migration.Direct 1:1 feedbackloop.(AP.12.10)Products Management Services (PMS) - Implementation of International Organization forStandardization (ISO) standards for the identification of medicinal products (IDMP) inEuropeEMA/676106/2019Page 10/43
1.2.1.2. Product Cross ReferenceThe elements highlighted in red in Figure 4 and table below summarise the information that ismapped to Article 57 data and that are subject to the transformation, migration and feedback loop.Figure 4The transformation and feedback loop rules apply as follows:PMSXEVMPD/Data ElementXEVPRM DataMigration to PMS RuleFeedback loop inArt.57 ruleelementProduct Cross-If the Marketing AuthorisationNo feedback loop ruleReference TypeStatus of the first version ofapplies.Term IDthe Art 57 product is ValidRenewed (8), or ValidTransferred (9) AND the dataelements AP.PEV.1 refers to anauthorised product (Type 2)then populate the value withRenewal or Transfer asapplies.If the above does not applyleave empty.First AssociatedPrevious EV CodeThe MPID derived from
previously submitted in Art.57 data format [i.e. via the eXtended Surveillance Medicinal Product Report message (XEVPRM)] transformed and remapped into the new data format and terminologies for further validation and enrichments; facilitate business continuity ensuring that PMS contains data comparable with what is available in
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Background Color Backer Panel Color (Optional) Lettering Color White Cement (pms 422) Driftwood (pms 416) Chracoal (pms 7540) Dark Brown (pms 412) Black (pms 6) Ash (pms 7527) Sandalwood (pms 4685) Parchment (pms 7528) Ivory (pms 468) Beige (
The Cruise Director helps to manage all the fun activities on the ship. The Cruise Director's name on our ship is. Some Crew Members on my cruise are:. Anyone with a Disney nametag is someone who can help me. PMS 485 PMS 294 PMS 485 PMS 294 PMS 485 PMS 294 PMS 485 PMS 294
This chart is a reference guide only. Pantone colors on computer screens may vary based on the graphics card and monitor used in your system. For true accuracy use the Pantone Color Publication. Commonly Used Shades Reflex Blue PMS 485 Orange 021 PMS 355 Yellow Violet PMS COLOR CHART Process Yellow PMS 100 PMS 101 PMS 102 Pantone Yellow PMS 103 .
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