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Official address Domenico Scarlattilaan 6 1083 HS Amsterdam The Netherlands

An agency of the European Union Address for visits and deliveries Refer to www.ema.europa.eu/how-to-find-us

Send us a question Go to www.ema.europa.eu/contact Telephone +31 (0)88 781 6000

© European Medicines Agency, 2020. Reproduction is authorised provided the source is acknowledged.

11 February 2020 EMA/676106/2019 Information Management

Products Management Services (PMS) - Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe

Chapter 7 : XEVMPD - PMS Migration guide

Version 1

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Table of contents

Introduction ... 3

Migration of Article 57 data into IDMP/SPOR format and terminology ... 3

1.1. Scope and strategy ... 4

1.1.1. Full data migration (i.e. initial load) ... 4

1.1.2. Delta data import ... 5

1.1.3. Feedback loop ... 5

1.1.4. Terminology mastering and migration ... 6

1.1.5. Version and conflicts management ... 6

1.2. Mapping and migration rules ... 7

1.2.1. Authorised medicinal product subject area ... 8

1.2.2. Marketing authorisation subject area ... 22

1.2.3. Organisation subject area ... 26

1.2.4. Clinical Particulars subject area ... 28

1.2.5. Packaged Medicinal Product subject area ... 29

1.2.6. Pharmaceutical Product subject area ... 31

1.2.7. Active Pharmaceutical Product subject area... 33

1.2.8. Ingredient subject area ... 43

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Introduction

Migration of Article 57 data into IDMP/SPOR format and terminology

The 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) legal obligations since 2012, into the ISO IDMP-compliant data format and terminologies. The transformed data 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 data 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 the Article 57 database and currently supports the EMA business and regulatory processes until integration with PMS will be implemented;

• facilitate transparency and comprehension of the data transformed into the new format by stakeholders 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 IDMP- compliant data format and terminologies which will reside in the PMS hub. Specifically, this chapter is aimed 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 and migration 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 back in the Art.57 database;

3. the Art.57-PMS data mapping, including the transformation rules that will be applied to the data during 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 individual stakeholders to implement this approach in their in-house systems. The mapping and migration rules provided are based on the XEVMPD and PMS logical data model which may be different from the individual stakeholder database architecture and it is beyond EMA remit to advice stakeholders on how to migrate the data recorded in their internal system to fulfil new legal requirements. However, the Agency is committed to share its own strategy and experience and encourages the stakeholders to reflect and transpose the transformation rules provided in section 1.2. Mapping and migration rules in their 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 this Guidance.

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1.1. Scope and strategy

The strategy to migrate the data into PMS and the feedback loop is described in this section and outlined in Figure 1.

Figure 1

The data is migrated from XEVMPD into PMS (i.e. as a database to database migration) and a feedback loop process is synchronising the data from PMS into XEVMPD via XEVPRM messages. The data is migrated from XEVMPD into PMS in two stages:

• full data migration, that allows the initial load of the data from XEVMPD into PMS; and subsequently

• delta import, that allows the periodic synchronisation from XEVMPD into PMS system with the newly 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 are migrated from the XEVMPD into PMS; this includes all historical versions of the XEVMPD products independently 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 or as necessary for pharmacovigilance activities);

the sender of the product (i.e. including all so-called 'XEVMPD Legacy Products' as maintained by EMA);

• 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 part of this phase of the project.

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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 the Referentials Management Services (RMS), Organisation Management Services (OMS) and

Substance Management Services (SMS) as applicable and with the appropriate cross references to the XEVMPD (EV Codes). Hence the EV Codes of the XEVMPD terminologies are loaded into a staging area where the EV Codes are transformed into the relevant RMS, OMS, SMS codes and terms.

2. Subsequently, the XEVMPD data is transformed into IDMP compatible format based on the PMS Logical Data Model (LDM) and according to the mapping rules described in section 1.2. Mapping and migration rules of this document when loading into PMS.

1.1.2. Delta data import

As part of the delta import, from XEVMPD into PMS all versions of new products created in the XEVMPD and all versions of products which have been amended in the XEVMPD since the last synchronisation are migrated to PMS. Vice versa, the feedback loop process takes place when migrating the data from PMS into the XEVMPD. During feedback loop process, all versions of new products created in PMS and all versions of products which have been amended in PMS since the last synchronisation are migrated to 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 same process of the full data migration process described in section 1.1.1. Full data migration (i.e. initial load). 1.1.1.

2. The XEVMPD synchronises with PMS by identifying, extracting and synchronising the changes received 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 the appropriate EV Code.

NOTE: Product versions created in the XEVMPD by a synchronisation from PMS are not synchronised to PMS again.

1.1.3. Feedback loop

The 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 Code and propagated to XEVMPD via XEVPRM.

NOTE 1: a version management system is in place whereby any XEVPRM generated from PMS that does not refer to the latest version of the product as available in the XEVMPD will be rejected by the XEVMPD parser. This is to ensure that information received directly in the XEVMPD (e.g. by external stakeholders via Art.57 submission) is never overwritten by the synchronisation from PMS (i.e. during the transition period). Further details of the version management system are described in section 1.1.5. Version and conflicts management.

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1.1.4. Terminology mastering and migration

At the time of the migration and transformation of the Art.57 data into PMS all XEVMPD data based on the controlled vocabularies (CVs) will be mapped and recoded against the terminology available in RMS, OMS and SMS respectively and as applicable. When the information is pushed back from PMS hub into XEVMPD via the feedback loop, the information based on RMS, OMS and SMS terminologies will 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):

S P O R

S X

P

O X

R X X X

1.1.5. Version and conflicts management

As each target system has a different route for data updates outside of the feedback loop (i.e. PMS via manual entry in the EMA Data Stewardship UI and XEVPMD via XML messages), data update conflicts may arise during migration and feedback loop synchronisation. Such conflicts are resolved by the XEVMPD being the overriding source of information. The versions in XEVMPD and in PMS may diverge at 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 in XEVMPD, but an update also occurred in PMS between the XEVPRM message timestamp and the time when the update was propagated to PMS (i.e. when in PMS an update occurred on an outdated version of the product).

In this situation, any XEVPRM generated from PMS that does not refer to the latest version of the product as available in the XEVMPD will be rejected by the XEVMPD parser. This is to ensure that information received directly in the XEVMPD (e.g. by external stakeholders via Art.57 submission) is never overwritten by the synchronisation from PMS (i.e. during the transition period). This solution implies the following:

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• Versions of a product within PMS contain a reference to the revision number in XEVMPD that they refer to. This is populated through the ETL (Extract-Transform-Load) and through the processing of the acknowledgement (ACK) messages.

• Once a product is changed in PMS, the message sent to XEVMPD contains a reference to the XEVMPD revision number that the change is based on. PMS will obtain this from the versions of the product.

• XEVMPD verifies, upon reception of the message, if the revision number is still the latest, in which case it will proceed normally (i.e. positive ACK should no other conflicts arise), or if there is a more current 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 ACK message).

1.2. Mapping and migration rules

This section describes the data elements available in the Article 57 database and the data fields in PMS to 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 into PMS hub is performed via a database to database data migration. Hence the description of the rules applicable for backwards and forward transformations, are presented listing the concerned data elements of the applicable subject areas, within the PMS LDM and as per Figure 2 below:

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Figure 2

1.2.1. Authorised medicinal product subject area

1.2.1.1. Medicinal Product

PMS defines medicinal products (for the purpose of the PMS database) in accordance to attributes Country, Active substance (or group of active substances contained in the same medicinal product), Pharmaceutical form, Medicinal product strength and Product name (including all different names associated 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 Authorised Products (CAPS). In addition, translations of the medicinal product name for medicinal products covered by the same marketing authorisation (MA) number are considered to be the same medicinal product name in PMS. In both cases, these types of products are listed as separate products in XEVMPD. Grouping of these separate products in XEVMPD under a single product entity in PMS will take place during the enrichment process and will be further analysed during the project’s migration design.

The elements highlighted in red in Figure 3and table below summarise the information that is mapped to Article 57 data and that are subject to transformation, migration and feedback loop.

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Figure 3

The transformation and feedback loop rules apply as follows:

PMS Data Element

XEVMPD/

XEVPRM Data element

Migration to PMS Rule Feedback loop in Art.57 rule

Combined Pharmaceutical Dose Form Term ID

Authorised pharmaceutical form (AP.APF.1)

Combined Pharmaceutical Form is a subset of the dose forms reported in Art.57 authorised pharma form (AP.APF.1).

The ETL will apply the following rule:

If AP.APF.1 is categorised in the EDQM pharmaceutical form list available in RMS as a combined Form, then the

If a combined

pharmaceutical form is available in PMS, the applicable and recoded value will populate the Art.57 Authorised Pharma Form with this value (AP.APF.1).

Alternatively, if this value is not available in PMS, the ETL will

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PMS Data Element

XEVMPD/

XEVPRM Data element

Migration to PMS Rule Feedback loop in Art.57 rule

applicable RMS ID will be used to populate the Combined Pharmaceutical Dose Form Term ID.

If AP.APF.1 is not categorised in the EDQM pharmaceutical form list available in RMS as a combined form, then then the Combined Pharmaceutical Dose Form Term ID will be empty.

As this field is repeatable in the Art.57 database, the migration will occur only if there is ONE reported Authorised Pharmaceutical Form in Art.57.

select the appropriate Manufactured

pharmaceutical forms in PMS and will populate its AP.APF.1.

Orphan Designation Status

Orphan Drug Status (AP.12.9)

Direct 1:1 migration.

NOTE: In PMS the values are CV, whilst in XEVMPD they are Boolean: the Boolean value will be mapped to the

applicable RMS Values (i.e. Y=

Valid and N= Leave empty)

Direct 1:1 feedback loop.

NOTE: the PMS values from the RMS CV will be transformed into the applicable Boolean value.

Paediatric Use flag Comment (AP.14) The information within the comment field (AP.14) will be parsed:

If comment AP.14 test:

'Medicinal product authorised for the treatment in children' than the flag is turned on in PMS.

If the flag is selected in PMS, a string with the text 'Medicinal product authorised for the treatment in children' will be appended in AP.14 n XEVPRM, unless it is already present.

Legal Basis Term ID Legal basis (AP.12.13)

Direct 1:1 migration. Direct 1:1 feedback loop.

Additional monitoring Flag

Intensive monitoring (AP.12.10)

Direct 1:1 migration. Direct 1:1 feedback loop.

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1.2.1.2. Product Cross Reference

The elements highlighted in red in Figure 4 and table below summarise the information that is mapped to Article 57 data and that are subject to the transformation, migration and feedback loop.

Figure 4 The transformation and feedback loop rules apply as follows:

PMS Data Element

XEVMPD/

XEVPRM Data element

Migration to PMS Rule Feedback loop in Art.57 rule

Product Cross- Reference Type Term ID

If the Marketing Authorisation Status of the first version of the Art 57 product is Valid Renewed (8), or Valid

Transferred (9) AND the data elements AP.PEV.1 refers to an authorised product (Type = 2) then populate the value with Renewal or Transfer as applies.

If the above does not apply leave empty.

No feedback loop rule applies.

First Associated Medicinal Product ID

Previous EV Code (AP.PEV.1)

The MPID derived from the X- Ref of the EV Code stated in AP.PEV.1 will be populated if available.

The EV Code for Development products will be ignored.

If the Art.57 Marketing Authorisation Status of the first version of the Art 57 product is Valid Renewed (8) or Valid Transferred (9) AND the Previous EV Code is of an

If the Type is Renewal or Transferred, the EV Code derived from the MPID X-Ref will be feedback looped.

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PMS Data Element

XEVMPD/

XEVPRM Data element

Migration to PMS Rule Feedback loop in Art.57 rule

authorised MP (type =2), then 1:1 mapping to PMS.

Second Associated Medicinal Product ID

Previous EV Code (AP.PEV.1)

This field must be populated in the same way as the First Associated Medicinal Product ID (the direction of the relationship determines which field is populated with the previous and which field is populated with the current product).

If the Type is Renewal or Transferred, the EV Code derived from the MPID X-Ref will be feedback looped.

From Date The timestamp of the

medicinal product for which the Marketing Authorisation has been changed to transfer or renewal will derive the From Date value to mark the

beginning of the relationship.

No feedback loop rule applies.

To Date No population possible No feedback loop rule

applies.

1.2.1.3. Pharmaceutical Dose Form

IDMP and XEVMPD present several differences in the support of Dose Forms that need to be considered during the transformation of data from XEVMPD to PMS and from PMS to EV. The following Figure 5 shows the 3 different types of Pharmaceutical Dose Forms supported in the PMS LDM, which follows the IDMP guidance:

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Figure 5

These three types of Pharmaceutical Dose Forms present in IDMP are defined and summarised as follows:

Medicinal Product.Combined Pharmaceutical Dose Form: The combined pharmaceutical dose form is a single term to describe two or more manufactured items that are intended to be

combined in a specific way to produce a single pharmaceutical product;

Manufactured Item.Manufactured Dose Form: This describes the pharmaceutical dose form of the manufactured item, where applicable, before transformation into the pharmaceutical product;

Pharmaceutical Dose Form.Administrable Dose Form: This shall describe the administrable dose form in accordance with the regulated product information. This is after it has undergone any necessary reconstitution, where applicable.

In Article 57 database, however, the following types of Pharmaceutical Dose Form apply:

MedicinalProduct.Authorised Pharmaceutical Form (AP.APF.1): there can be 1..* of these forms;

Pharmaceutical Product.Administrable Pharmaceutical Form (PP.1): there can be 1..* of these forms.

Also, the full Manufactured item is not available in the Article 57 database. However, it is the intention to populate the PMS Manufactured Item as much as possible with the data currently available in the Article 57 database, This is done by using the process of transformation of data from XEVMPD to PMS

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to facilitate the mapping and enrichment efforts from external stakeholders and to maximise the re- use of the currently available data.

The Authorised Pharmaceutical Form in the Article 57 database will also contain the combined pharmaceutical dose forms where applicable (i.e.: where the SmPC mentions such a dose form).

An analysis of the current Article 57 data highlighted that around 90% of the existing Article 57 products are composed of a single Pharmaceutical Product and a single Authorised Dose Form and that in such cases Authorised and Administrable Dose Forms are equal.

It also must be noted that the MedicinalProduct.Authorised Pharmaceutical Form (AP.APF.1) is used in the calculation of the chargeable units in PhV fees and therefore feedback loop rules should be

particularly precise and accurate.

1.2.1.3.1. Import from XEVMPD into PMS

• The PMS LDM has been extended to support Authorised Pharmaceutical Form as well. This will be for internal EV-PMS synchronisation purposes only. This attribute shall be populated by

copying AP.APF.1 at import time. This attribute will be visible to EMA Data Stewards in the EMA Data Stewardship UI (as part of the MDM Physical Data Model), but it will not be exposed externally via API and subject to maintenance activities from external stakeholders.

• A rule is implemented that, if a single Authorised Pharmaceutical Form and a single

Pharmaceutical Product are present in the Article 57 database, and if such Form is NOT of type Combined (attribute present in the RMS list Combined Pharmaceutical Form), in PMS one Manufactured Item shall be created whose Manufactured Dose Form shall be equal to the Authorised Dose Form and whose Ingredients will be the same as Ingredients of the XEVMPD Pharmaceutical Product. If there are more than one Authorised Pharmaceutical Forms in EV, no Manufactured Item structure is created in PMS at all. For example, a product whose Authorised Dose Form in XEVMPD is “Tablet” and that has one active ingredient of “Paracetamol 500 mg”, will result in one single Manufacture Item with Manufactured Dose Form “Tablet” and the Manufactured Item will have one single ingredient as “Paracetamol 500 mg”.

• If one (and only one) Authorised Pharmaceutical Form is present in the Article 57 database, and if such Authorised Pharmaceutical Form is of type Combined (attribute present in the RMS list Combined Pharmaceutical Form), it shall be used as source for the Medicinal Product.Combined Pharmaceutical Dose Form. Otherwise, the target PMS Combined Pharmaceutical Form attribute will remain empty.

• PMS Pharmaceutical Product.Administrable Dose Form shall be populated with information from the Art.57 Pharmaceutical Product.Administrable Pharmaceutical Form (PP.1) directly, this structure is subject to a 1:1 direct mapping.

1.2.1.3.2. Feedback from PMS into EV

• The above-mentioned new attribute in PMS LDM Authorised Pharmaceutical Form, shall be used as source for the same attribute (AP.APF.1) in the Article 57 database. This attribute ensures that the existing data provided in the Article 57 database submission and used for the calculation of the pharmacovigilance fees is safeguarded from the migration and feedback loop from PMS.

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• However, the above attribute will only be populated in Products imported from the Article 57 database. Products first created in PMS and subsequently updated through the API shall not have Authorised Pharmaceutical Form populated (it will not be exposed via API to external stakeholders and therefore be subject to maintenance activities). In that case, the Authorised Pharmaceutical Form will be automatically calculated by PMS based on the following rules:

− if there is a Medicinal Product.Combined Pharmaceutical Dose Form in PMS, it shall be used to populate Authorised Pharmaceutical Form in PMS,

− if there is NOT a Medicinal Product.Combined Pharmaceutical Dose Form in PMS, all distinct Manufactured Item.Manufactured Dose Forms shall be used to populate Authorised Pharmaceutical Forms in PMS.

• The calculated Authorised Pharmaceutical Form could be manually overwritten by a Data Steward using the EMA Data Stewardship UI.

• Authorised Pharmaceutical Form in the Article 57 database (AP.APF.1) will be populated from this calculated (and manually validated) Authorised Pharmaceutical Form from PMS.

1.2.1.3.3. Expected behaviour

• Around 90% of the Article 57 products will have an automatic population of the Manufactured Item structure. The rest will require enrichment from Industry.

• The fee calculation remains stable thanks to the following rules:

− Authorised Pharmaceutical Form shall be mapped directly between the 2 systems as long as XEVMPD remains the master through a new internal PMS attribute,

− MedicinalProduct.Authorised Pharmaceutical Form (AP.APF.1) can always be populated in XEVMPD even when none has been provided through the PMS API.

1.2.1.3.4. Authorised Pharmaceutical Dose Form

The elements highlighted in red in Figure 6 below summarise the information that is mapped to Article 57 data and that are subject to the transformation, migration and feedback loop.

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Figure 6 The transformation and feedback loop rules apply as follows:

PMS Data Element

XEVMPD/

XEVPRM Data element

Migration to PMS Rule Feedback loop in Art.57 rule

Authorised Dose Form Term ID

Authorised pharmaceutical form (AP.APT.1)

Direct 1:1 migration. Direct 1:1 feedback loop.

1.2.1.4. Medicinal Product Type

The elements highlighted in red in Figure 7 and table below summarise the information that is mapped to Article 57 data and that are subject to the transformation, migration and feedback loop.

Figure 7 The transformation and feedback loop rules apply as follows:

PMS Data Element

XEVMPD/

XEVPRM Data element

Migration to PMS Rule Feedback loop in Art.57 rule

XEVMPD Medicinal Product Type

information

Medicinal product types

(AP.12.MPT.1)

Direct 1:1 migration. Direct 1:1 feedback loop.

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PMS Data Element

XEVMPD/

XEVPRM Data element

Migration to PMS Rule Feedback loop in Art.57 rule

(Medicinal Product Type Term ID)

1.2.1.5. ATC Medicinal Product

The elements highlighted in red in Figure 8 and table below summarise the information that is mapped to Article 57 data and that are subject to the transformation, migration and feedback loop.

Figure 8 The transformation and feedback loop rules apply as follows:

PMS Data Element

XEVMPD/

XEVPRM Data element

Migration to PMS Rule Feedback loop in Art.57 rule

ATC Term ID Number

Product ATC Code(s) (AP.ATC.1)

Direct 1:1 migration. Direct 1:1 feedback loop.

1.2.1.6. Master File

The elements highlighted in red in Figure 9and table below summarise the information that is mapped to Article 57 data and that are subject to the transformation, migration and feedback loop.

While other types of master files might be added in PMS in the future, for the scope of Art 57 migration the only available type is Pharmacovigilance Master File.

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Figure 9 The transformation and feedback loop rules apply as follows:

PMS Data Element

XEVMPD/

XEVPRM Data element

Migration to PMS Rule Feedback loop in Art.57 rule

Master File Type Term ID

This will be automatically set as 'Pharmacovigilance MFL'

n/a

File Code ID Pharmacovigilance System Master File Location (PSMFL) code (AP.6)

Direct 1:1 migration. Direct 1:1 feedback loop, but only where the type is

pharmacovigilance master files.

1.2.1.7. Medicinal Product Name Part

The elements highlighted in red in Figure 10 and table below summarise the information that is mapped to Article 57 data and that are subject to the transformation, migration and feedback loop.

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Figure 10

The transformation and feedback loop rules apply as follows:

PMS Data Element

XEVMPD/

XEVPRM Data element

Migration to PMS Rule Feedback loop in Art.57 rule

Medicinal Product Name Part Text

Full Presentation Name (AP.13.1)

Direct 1:1 mapping Direct 1:1 mapping

Medicinal Product Name Part Type

Medicinal Product name parts (AP.13.2 to AP.13.6)

If AP.13.2 is populated in XEVMPD then insert name of type invented

If AP.13.3 is populated in XEVMPD then insert name of type scientific

If AP.13.4 is populated in XEVMPD then insert name of type trademark

If AP.13.5 is populated in XEVMPD then insert name of type strength

If AP.13.6 is populated in XEVMPD then insert name of type pharmaceutical dose form

If the type is invented then populate AP.13.2 (Short Name)

If the type is scientific then populate AP.13.3 (INN/Common Name) If the type is trademark then populate AP.13.4 (Company Name) If the type is strength then populate AP.13.5 (strength Name)

If the type is pharma form dose part then populate AP.13.6 (Form Name) If the type is ANY OTHER, the contents must be concatenated to the

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PMS Data Element

XEVMPD/

XEVPRM Data element

Migration to PMS Rule Feedback loop in Art.57 rule

following fields following the logic:

- where 'invented' is populated, concatenate invented + formulation + intended use + target population + flavour + container + device and populate AP.13.2 - where 'invented' is not populated, concatenate scientific + formulation + intended use + target population + flavour + container + device and populate AP.13.3 The order of the concatenation might be amended at a later stage, to maximise the efficiency of the match with the current Art 57 guidance on naming.

Language Term ID n/a Select the Language based on the Authorisation Country, where the

mapping is straightforward (one official language per country).

If no Country is available then default English.

n/a

1.2.1.8. Attached Document

The elements highlighted in red in Figure 11 and table below summarise the information that is mapped to Article 57 data and that are subject to the transformation, migration and feedback loop.

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Figure 11 The transformation and feedback loop rules apply as follows:

PMS Data Element

XEVMPD/

XEVPRM Data element

Migration to PMS Rule Feedback loop in Art.57 rule

Media Type Term ID File type (ATT.3) Direct mapping 1:1 Direct mapping 1:1 Document Type

term ID

Attachment type (ATT.5)

n/a

Note: This field cannot be mapped directly in ATT.5 and therefore the migration will ignore this information

The value PPI will be set as default in ATT.5 Attachment type

Document Reference

Direct mapping 1:1 Direct mapping 1:1

Effective Date Attachment version date (ATT.8)

Direct 1:1 mapping Direct 1:1 mapping

Alternative (Attached Document) Identifier

Attachment EV Code (AP.PPI.1)

Direct 1:1 mapping Direct 1:1 mapping

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PMS Data Element

XEVMPD/

XEVPRM Data element

Migration to PMS Rule Feedback loop in Art.57 rule

EV Code

Language Term ID Attachment Language Code (ATT.6)

Direct 1:1 mapping with the exception of value ST (Standard) that will be recoded to English in PMS Past the initial migration the value Standard (ST) should not overwrite the PMS

language, but maintain it as is.

Direct 1:1 mapping where PMS language list matched EV language list. Where not, map to value ST (Standard).

1.2.2. Marketing authorisation subject area

The elements highlighted in red in Figure 12 and table below summarise the information that is mapped to Article 57 data and that are subject to the transformation, migration and feedback loop.

Figure 12 1.2.2.1. Marketing authorisation

The elements highlighted in red in Figure 13 and table below summarise the information that is mapped to Article 57 data and that are subject to the transformation, migration and feedback loop.

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Figure 13 The transformation and feedback loop rules apply as follows:

PMS Data Element

XEVMPD/ XEVPRM Data element

Migration to PMS Rule Feedback loop in Art.57 rule Marketing

Authorisation Number

Authorisation number (AP.12.4)

EU Number (AP.12.8)

1:1 direct mapping from AP.12.4

1:1 direct mapping in AP.12.4

AND

If the Marketing Authorisation is equal to CAP, populate AP.12.4 and EU Number (AP.12.8) via a 1:1 direct mapping.

Country Term ID Authorisation country code (AP.12.1)

If Authorisation Country code (AP.12.1) is not "EU" then Country Term ID is populated with the AP.12.1. Country Term ID value via a 1:1 Direct mapping.

If Authorisation Country code (AP.12.1) is equal to "EU"

Country Term ID is left empty

If Country Term ID is not empty, then the value AP.12.1. should be set via a 1:1 direct mapping.

If Country Term ID is empty, AP.12.1. is populated with the value available in Country Grouping Term ID via a 1:1 direct mapping.

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PMS Data Element

XEVMPD/ XEVPRM Data element

Migration to PMS Rule Feedback loop in Art.57 rule Country Grouping

Term ID

Authorisation country code (AP.12.1) (when AP.12.1 is equal to

"EU")

If Authorisation Country code (AP.12.1) is equal to "EU"

then Country Grouping Term ID value via a 1:1 Direct mapping.

If Authorisation Country code (AP.12.1) is not equal to "EU"

Country Grouping Term ID is left empty

If Country Grouping Term ID is not empty, then AP.12.1. should be set to this value via a 1:1 direct mapping.

If Country Grouping Term ID is empty, AP.12.1.is populated with the value of Country ID via a 1:1 Direct mapping.

Authorisation Status Term ID

Authorisation status (AP.12.3)

1:1 direct mapping 1:1 direct mapping

Authorisation Status Date

Authorisation/renewal date (AP.12.5) Invalidated date (AP.12.12)

If AP.12.3 Authorisation status is in the 'Group of Invalid' (i.e. equal to either

"Not valid - Withdrawn by marketing authorisation holder (3)", "Not valid - Revoked by Competent Authority (4)", "Not Valid - Not Renewed by

Competent Authority (5)",

"Not Valid - Not Submitted for Renewal by Marketing Authorisation Holder (6)",

"Not valid - Expired due to Sunset Clause (7)", "Not Valid - Superseded by Marketing Authorisation Renewal/Variation (10)", "Not Valid - Superseded by

Marketing Authorisation Transfer (11)") or status is

"Valid Suspended (2)" then populate this field with AP.12.12. Invalidated Date via 1:1 direct mapping;

If AP.12.3 is in the 'Group of Valid' (i.e. equal to either

"Valid (1)", , "Valid -

If Authorisation Status is in the 'Group of Invalid' or status is

"Valid Suspended (2)"

then Invalidated date (AP.12.12) is

populated via a 1:1 direct mapping.

If Authorisation Status is in the 'Group of valid' then

Authorisation Date (AP.12.5) is populated via a 1:1 direct mapping.

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PMS Data Element

XEVMPD/ XEVPRM Data element

Migration to PMS Rule Feedback loop in Art.57 rule Renewed/Varied Marketing

Authorisation (8)", "Valid - Transferred Marketing Authorisation (9)") then populate this field with AP.12.5. Authorisation Date via 1:1 direct mapping.

Date of First

Authorisation

NOTE: Derived from Authorisation/renewal date (AP.12.5)

If it is the first version of the product then populate this field with AP.12.5.

Authorisation Date via 1:1 direct mapping.

If it is not the first version of the product then leave this field with the existing value.

No feedback loop in XEVMPD.

1.2.2.2. Marketing authorisation procedure

The elements highlighted in red in Figure 14 and table below summarise the information that is mapped to Article 57 data and that are subject to the transformation, migration and feedback loop.

Figure 14 The transformation and feedback loop rules apply as follows:

PMS Data Element

XEVMPD/

XEVPRM Data element

Migration to PMS Rule Feedback loop in Art.57 rule

Marketing Authorisation Procedure Type Term ID

Authorisation procedure (AP.12.2)

1:1 direct mapping 1:1 direct mapping

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PMS Data Element

XEVMPD/

XEVPRM Data element

Migration to PMS Rule Feedback loop in Art.57 rule

Marketing Authorisation Procedure Number

MRP/DCP/EMEA number (AP.12.7)

1:1 direct mapping 1:1 direct mapping

1.2.3. Organisation subject area

1.2.3.1. Organisation role

The elements highlighted in red in Figure 15 and table below summarise the information that is mapped to Article 57 data and that are subject to the transformation, migration and feedback loop.

Figure 15 The transformation and feedback loop rules apply as follows:

PMS Data Element

XEVMPD/

XEVPRM Data element

Migration to PMS Rule Feedback loop in Art.57 rule

Organisation Role Status ID

n/a For every Product imported by XEVMPD set default value to 'MAH' (i.e. all the

organisations linked with an authorized product are MAHs in Art.57)

No feedback loop required

Pharmacovigilance Enquiry Email

Pharmacovigilance enquiry email (AP.7)

1:1 direct mapping 1:1 direct mapping

Pharmacovigilance Enquiry Phone

Pharmacovigilance enquiry phone (AP.8)

1:1 direct mapping 1:1 direct mapping

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1.2.3.2. Location area

The elements highlighted in red in Figure 16 and table below summarise the information that is mapped to Article 57 data and that are subject to the transformation, migration and feedback loop.

Figure 16 The transformation and feedback loop rules apply as follows:

PMS Data Element

XEVMPD/

XEVPRM Data element

Migration to PMS Rule Feedback loop in Art.57 rule

Parent Location ID Organisation Sender Identifier (O.5)

1:1 direct mapping to the OMS ID as mapped with the ID of the organisation assigned in the EudraVigilance registration system.

1:1 direct mapping (TBC)

Address ID Address (O.6) 1:1 direct mapping 1:1 direct mapping

OMS ID Marketing

authorisation holder (MAH) code (AP.4)

1:1 direct mapping 1:1 direct mapping

1.2.3.3. Contact

The elements highlighted in red in Figure 17 and table below summarise the information that is mapped to Article 57 data and that are subject to the transformation, migration and feedback loop.

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Figure 17 The transformation and feedback loop rules apply as follows:

PMS Data Element

XEVMPD/

XEVPRM Data element

Migration to PMS Rule Feedback loop in Art.57 rule

Contact Role Type Term ID

n/a A role type is set to QPPV by default when migrating the QPPV information as available in the Qualified Person responsible for

Pharmacovigilance (QPPV) code (AP.5) field

n/a

Confidentiality Indicator

n/a The Value is set by default to 'Confidential' when the Contact Role Type Term ID is set to QPPV

n/a

External Contact Identifier

Qualified Person responsible for Pharmacovigilance (QPPV) code (AP.5)

1:1 direct mapping 1:1 direct mapping

1.2.4. Clinical Particulars subject area

1.2.4.1. Therapeutic indication

The elements highlighted in red in Figure 18 pictures below summarise the information that is mapped to Article 57 data and that are subject to the transformation, migration and feedback loop.

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Figure 18 The transformation and feedback loop rules apply as follows:

PMS Data Element

XEVMPD/

XEVPRM Data element

Migration to PMS Rule Feedback loop in Art.57 rule

Intended Effect Term ID

n/a If AP.IND.3 contains the MedDRA code 10036898, then this field is populated with the value 100000022817

(Prophylaxis)

n/a

Indication as Disease Symptom Procedure MedDRA Term ID

Indication - MedDRA Code (AP.IND.3)

Recode AP.IND.3 values against the relevant RMS Term ID in RMS whose code is equal to the value in AP.IND.3 and the version is equal to MedDRA version (AP.IND.1) and the level is equal to MedDRA level (AP.IND.2).

If the level does not match, then LLT value is used as default value.

Direct mapping 1:1 MedDRA version (AP.IND.1) is set as retrieved from the term ID in RMS;

The MedDRA level (AP.IND.2) is set as retrieved from the term ID in RMS.

1.2.5. Packaged Medicinal Product subject area

The elements highlighted in red in Figure 19 and table below summarise the information that is mapped to Article 57 data and that are subject to the transformation, migration and feedback loop.

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Figure 19 The transformation and feedback loop rules apply as follows:

PMS Data Element

XEVMPD/

XEVPRM Data element

Migration to PMS Rule Feedback loop in Art.57 rule

Package Description Package description (AP.13.7)

1:1 direct mapping The information in this area will not be feedback looped into XEVPRM. Effectively all the information in XEVPMD Package description (AP.13.7) can only be maintained via XEVPRM and will not be modified by any of the PMS activities.

1.2.5.1. Manufactured Item

The elements highlighted in red in Figure 20 and table below summarise the information that is mapped to Article 57 data and that are subject to the transformation, migration and feedback loop.

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Figure 20 The transformation and feedback loop rules apply as follows:

PMS Data Element

XEVMPD/

XEVPRM Data element

Migration to PMS Rule Feedback loop in Art.57 rule

Manufactured Dose Form Term ID

For additional information on PMS and XEVMPD Pharmaceutical Dose Form information migration and mapping, refers to section 1.2.1.3. of this guidance.

Authorised pharmaceutical form (AP.APF.1)

If there is only one Authorised pharmaceutical form

(AP.APF.1) then repeat its value for each manufactured item. This migration is an assumption because there is no Manufactured Item in XEVMPD; in PMS a

Manufactured Item will be created per each

Pharmaceutical Product available in the XEVMPD automatically importing the relevant ingredients as available in the XEVMPD.

If there are more than 1 Authorised Pharmaceutical Forms in EV, no Manufactured Item structure is created in PMS and no migration occurs.

N/A

1.2.6. Pharmaceutical Product subject area

1.2.6.1. Pharmaceutical Product

The elements highlighted in red in Figure 21 and table below summarise the information that is mapped to Article 57 data and that are subject to the transformation, migration and feedback loop.

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Figure 21 The transformation and feedback loop rules apply as follows:

PMS Data

Element

XEVMPD/

XEVPRM Data element

Migration to PMS Rule Feedback loop in Art.57 rule

Administrable Dose Form Term ID For additional information on PMS and XEVMPD Pharmaceutica l Dose Form information migration and mapping, refers to section 1.2.1.3. of this guidance.

Administrable Pharmaceutica l Form (PP.1)

1:1 Direct mapping. 1:1 Direct mapping.

Unit of Presentation Term ID

Denominator unit

(PP.ACT.8)

If (Low Amount) Denominator Unit (PP.ACT.8) of the active ingredient is equal to "Unit of Presentation"

(LK_CONCENTRATIONUNITDEN.UOM_UO P = 'P'),

No feedback loop required, XEVPMD will

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PMS Data

Element

XEVMPD/

XEVPRM Data element

Migration to PMS Rule Feedback loop in Art.57 rule

then Concatenate (Low Amount)

Denominator Prefix (PP.ACT.7) and (Low Amount) Denominator Unit (PP.ACT.8) and codify the result with an RMS term NAME from the Unit of Presentation (UoP) list.

Otherwise, ignore.

be always populated with the value available in the Ingredient.Presentatio n Denominator Unit

Route of Administration Term ID

Administration route

(PP.AR.1)

1:1 Direct mapping 1:1 Direct mapping

Device Type Term ID

n/a Always set the default value to

“(Combined) Medical Device (aka ATMP)”

when Medical device Code (PP.MD.1) is available in the XEVMPD.

No feedback loop required

Device Identifier

Medical device Code

(PP.MD.1)

1:1 Direct mapping. If Device Type Term ID is equal to

'(Combined) Medical' then 1:1 Direct mapping.

If Device Type Term ID is not equal to '(Combined) Medical' then do not feedback loop.

1.2.7. Active Pharmaceutical Product subject area

The elements highlighted in red in Figure 22 below summarise the information that is mapped to Article 57 data and that are subject to the transformation, migration and feedback loop.

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Figure 22 1.2.7.1. Ingredient

The elements highlighted in red in Figure 23 and table below summarise the information that is mapped to Article 57 data and that are subject to the transformation, migration and feedback loop.

Figure 23 The transformation and feedback loop rules apply as follows:

PMS Data Element

XEVMPD/

XEVPRM Data element

Migration to PMS Rule Feedback loop in Art.57 rule

Ingredient Role Term ID

active ingredient (PP.ACT)

1:1 Direct mapping 1:1 Direct mapping

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PMS Data Element

XEVMPD/

XEVPRM Data element

Migration to PMS Rule Feedback loop in Art.57 rule

excipient (PP.EXC) adjuvant (PP.ADJ)

1.2.7.2. Ingredient Substance Strength

The elements highlighted in red in Figure 24 and table below summarise the information that is mapped to Article 57 data and that are subject to the transformation, migration and feedback loop.

Figure 24

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The transformation and feedback loop rules apply as follows:

PMS Data Element

XEVMPD/

XEVPRM Data element

Migration to PMS Rule Feedback loop in Art.57 rule

Substance ID Excipient substance code (PP.EXC.1) Adjuvant substance code (PP.ADJ.1) Active ingredient substance code (PP.ACT.1)

According to the Ingredient role 1:1 Direct Mapping and recode against SMS ID as follows:

• Excipient substance code (PP.EXC.1)

• Adjuvant substance code (PP.ADJ.1)

• Active ingredient

substance code (PP.ACT.1)

Query SMS by SMS-ID, obtain the EV Code and populate this field.

According to the Ingredient role 1:1 Direct Mapping and Recode against EV Code:

• PP.ACT.1 if ingredient role is Active

• PP.ADJ.1 if ingredient role is Adjuvant

• PP.EXC.1 if ingredient role is anything else

1.2.7.2.1. Strength migration rationale

The XEVPMD schema and the PMS LDM use different models to capture an ingredient's strength and unit of presentation:

• PMS LDM (following IDMP) allows strength to be expressed separately for Presentation and Concentration (relevant for liquids and powders), whereas the XEVMPD has only one set of attributes to capture strength;

• PMS LDM (following IDMP) has a separate attribute to capture Unit of Presentation which is captured at the Pharmaceutical Product level, whereas XEVMPD sometimes stores unit of presentation in the denominator of the strength (e.g. 100 mg / tablet, or 10 mg / puff) and sometimes stores unit of measurement in the denominator of strength (e.g. 100 mg / 100 ml).

This attribute is mandatory in IDMP;

In PMS, all the Presentation and Concentration attributes shall be treated (and hereby referred to) as a block.

NOTE: according to ISO IDMP standards specifications, the Presentation block in PMS is mandatory but not yet available, until the data is enriched from external stakeholders with the additional information, as will be required in the FHIR message and as described in Chapter 2 and Chapter 6 of this EU

Implementation Guide.

The following general principles and rules apply for the migration and feedback loop of the presentation and concentration blocks:

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On the migration of the data from XEVMPD into PMS, all of the Presentation block of

Ingredient Substance Strength will be populated if the unit in the source system (i.e. in XEVMPD) is of type presentation; Otherwise (i.e. if the unit in the XEVMPD is of type measurement), the

Concentration block shall be populated. The basic rule to populate them or not depends on the type of the unit at source. This rule can be generally expressed as follows:

On the feedback loop of the data from PMS into XEVMPD, the Presentation block from PMS will be propagated in XEVMPD in case it is populated; in case it is not populated in PMS, the Concentration block shall be used as source of data for the feedback loop. In the case that both blocks are populated (scenario only possible for products submitted directly to PMS through the API), the Presentation block will take precedence. This logic can be represented as follows:

Each of the attributes of the block has its own mapping rules as presented in section 1.2.7.2.3. and 1.2.7.2.4. Concentration Strength Block.

1.2.7.2.2. Transformation of Units of Measurements

As generally applicable to all data that is based on controlled terminologies in XEVPMD, the individual terms are mapped and recoded with the terms available in RMS when migrating the data from XEVPMD to PMS; and vice versa, all RMS terms will be recoded against XEVPMD Controlled Terminologies during the feedback loop from PNMs to XEVPMD.

The XEVMPD units of measurement are presented as a combination of unit prefix and actual unit (e.g.

10 mg, where m-milli and g-gram are stored in 2 separate attributes), whereas in the PMS LDM it is allowed to store any RMS unit of measurement as a single attribute (e.g. 10 mg).

When transforming the Unit of Measurement available in the XEVPMD into the RMS corresponding list, a mapping of the terms in RMS occurs to represent the composition of units. in the XEVMPD, a given unit is composed of a prefix and another unit: in the transformation, the term from the units of measurement prefix and the term from the units of measurement list are concatenated to form one single term. For example, the term Milli and the term Gram will be concatenated in the term Milligram (from UoM). Once the concatenation is performed, the searching of the values in the RMS list occurs.

1.2.7.2.3. Presentation Strength Block

The individual mapping rules of each presentation strength block is presented in this section.

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The Strength will be migrated according to the value in the EVMPD/XEVPRM (Low Amount) Denominator Unit (PP.ACT.8). If (Low Amount) Denominator Unit (PP.ACT.8) is of type Unit of Presentation the 'Presentation Strength Block' will be migrated as follows:

PMS Data Element

XEVMPD/

XEVPRM Data element

Migration to PMS Rule Feedback loop in Art.57 rule

Presentation Lower Range Numerator Quantity

Low Amount Numerator Value (PP.ACT.3)

1:1 Direct mapping 1:1 Direct mapping

Presentation Lower Range Numerator Unit Term ID

(Low Amount) Numerator Prefix (PP.ACT.4) Low Amount Numerator Unit (PP.ACT.5)

Concatenate the value available in (Low Amount) Numerator Prefix (PP.ACT.4) and (Low Amount) Numerator Unit (PP.ACT.5), to map with an RMS term from the UoM list.

1:1 Direct mapping

Feedback loop parses the prefix as a string and extracts the relevant parts from the single input.

NOTE: XEVMPD must have prefix values, hence simple UoM (i.e.

gram) must be prefixed with the default value "single".

Presentation Lower Range Denominator Quantity

Low Amount Denominator Value (PP.ACT.6)

1:1 Direct mapping

1 is the default value should no other value be provided.

1:1 Direct mapping NOTE: in the presence of both Presentation and Concentration, the Presentation block is automatically used for XEVMPD population.

Presentation Lower Range Denominator Unit Term ID

Low Amount Denominator Unit (PP.ACT.8)

1:1 Direct mapping

If populated, the default value

"Each" should be used. The actual Unit of Presentation shall be stored at

Pharmaceutical Product level.

1:1 Direct mapping Feedback loop parses the prefix as a string and extracts the relevant parts from the single input.

NOTE: XEVMPD must have prefix values, hence simple UoM (i.e.

gram) must be prefixed with the default value "single".

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PMS Data Element

XEVMPD/

XEVPRM Data element

Migration to PMS Rule Feedback loop in Art.57 rule

Presentation Quantity Operator Term ID

Concentration Type Code (PP.ACT.2)

1:1 Direct mapping 1:1 Direct mapping NOTE: in the presence of both Presentation and Concentration, the Presentation block is automatically used for XEVMPD population.

Presentation Upper Range Numerator Quantity

High Amount Numerator Value (PP.ACT.9)

NOTE: The whole Upper block is mandatory if Presentation Quantity Operation Term ID is Range; it must be empty otherwise.

1:1 Direct mapping if applicable.

1:1 Direct mapping NOTE: in the presence of both Presentation and Concentration, the Presentation block is automatically used for XEVMPD population.

Presentation Upper Range Numerator Unit Term ID

High Amount Numerator Prefix (PP.ACT.10) High Amount Numerator Unit (PP.ACT.11)

NOTE: The whole Upper block is mandatory if Presentation Quantity Operation Term ID is Range; it must be empty otherwise.

Concatenate the value available in High Amount Numerator Prefix (PP.ACT.10) and High Amount Numerator Unit (PP.ACT.11), to map with an RMS term from the UoM list.

1:1 Direct mapping Feedback loop parses the prefix as a string and extracts the relevant parts from the single input.

NOTE: XEVMPD must have prefix values, hence simple UoM (i.e.

gram) must be prefixed with the default value "single".

Presentation Upper Range Denominator Quantity

High Amount Denominator Value (PP.ACT.12)

1:1 Direct mapping 1:1 Direct mapping NOTE: in the presence of both Presentation and Concentration, the Presentation block is automatically used for XEVMPD population.

Presentation Upper Range Denominator Unit Term ID

High Amount Denominator Unit (PP.ACT.14)

1:1 Direct mapping

If populated, the default value

"Each" should be used. The actual Unit of Presentation

1:1 Direct mapping Feedback loop parses the prefix as a string and extracts the

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