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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

Products Management Services (PMS) - Implementation of International Organization for

Standardization (ISO) standards for the identification of medicinal products (IDMP) in

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EMA/676106/2019 /43

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


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)


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


PMS

Data Element

XEVMPD/

XEVPRM Data

element


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


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


PMS

Data Element

XEVMPD/

XEVPRM Data

element


Art.57 rule

Authorised Dose

Form Term ID

Authorised

pharmaceutical

form (AP.APT.1)


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


PMS

Data Element

XEVMPD/

XEVPRM Data

element


Art.57 rule

XEVMPD

Medicinal

Product

Type

information

Medicinal product

types

(AP.12.MPT.1)


loop.



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PMS

Data Element

XEVMPD/

XEVPRM Data

element


Art.57 rule

(Medicinal Product

Type Term ID)

1.2.1.5. ATC Medicinal Product



Figure 8


PMS

Data Element

XEVMPD/

XEVPRM Data

element


Art.57 rule

ATC Term ID

Number

Product ATC

Code(s)

(AP.ATC.1)


loop.

1.2.1.6. Master File

The elements highlighted in red in Figure 9and table below summarise the information that is mapped


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


PMS

Data Element

XEVMPD/

XEVPRM Data

element


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)


loop, but only where

the type is

pharmacovigilance

master files.

1.2.1.7. Medicinal Product Name Part





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Figure 10


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



of type scientific



of type trademark



of type strength



of type pharmaceutical

dose form

If the type is invented

then populate AP.13.2

(Short Name)

If the type is scientific


(INN/Common Name)

If the type is trademark


(Company Name)

If the type is strength


(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





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Figure 11


PMS

Data Element

XEVMPD/

XEVPRM Data

element


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)


Alternative

(Attached

Document)

Identifier

Attachment EV

Code (AP.PPI.1)




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PMS

Data Element

XEVMPD/

XEVPRM Data

element


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



Figure 12

1.2.2.1. Marketing authorisation





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Figure 13


PMS

Data Element

XEVMPD/ XEVPRM

Data element


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.


(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


Art.57 rule

Country Grouping

Term ID

Authorisation country

code (AP.12.1) (when

AP.12.1 is equal to

"EU")


(AP.12.1) is equal to "EU"

then Country Grouping Term

ID value via a 1:1 Direct

mapping.


(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


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



Figure 14


PMS

Data Element

XEVMPD/

XEVPRM Data

element


Art.57 rule

Marketing

Authorisation

Procedure Type

Term ID

Authorisation

procedure

(AP.12.2)




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PMS

Data Element

XEVMPD/

XEVPRM Data

element


Art.57 rule

Marketing

Authorisation

Procedure Number

MRP/DCP/EMEA

number (AP.12.7)


1.2.3. Organisation subject area

1.2.3.1. Organisation role



Figure 15


PMS

Data Element

XEVMPD/

XEVPRM Data

element


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)


Pharmacovigilance

Enquiry Phone

Pharmacovigilance

enquiry phone

(AP.8)




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1.2.3.2. Location area



Figure 16


PMS

Data Element

XEVMPD/

XEVPRM Data

element


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)


1.2.3.3. Contact





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Figure 17


PMS

Data Element

XEVMPD/

XEVPRM Data

element


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




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Figure 18


PMS

Data Element

XEVMPD/

XEVPRM Data

element


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





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Figure 19


PMS

Data Element

XEVMPD/

XEVPRM Data

element


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





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Figure 20


PMS

Data Element

XEVMPD/

XEVPRM Data

element


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





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Figure 21


PMS

Data

Element

XEVMPD/

XEVPRM

Data

element


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


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



Figure 23


PMS

Data Element

XEVMPD/

XEVPRM Data

element


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


Art.57 rule

excipient (PP.EXC)

adjuvant (PP.ADJ)

1.2.7.2. Ingredient Substance Strength



Figure 24



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PMS

Data Element

XEVMPD/

XEVPRM Data

element


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


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



and extracts the


single input.

NOTE: XEVMPD must

have prefix values,


gram) must be

prefixed with the




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PMS

Data Element

XEVMPD/

XEVPRM Data

element


Art.57 rule

Presentation

Quantity Operator

Term ID

Concentration

Type Code

(PP.ACT.2)

1:1 Direct mapping

1:1 Direct mapping






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






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.


available in High Amount


and High Amount Numerator

Unit (PP.ACT.11), to map with

an RMS term from the UoM

list.

1:1 Direct mapping



and extracts the


single input.

NOTE: XEVMPD must

have prefix values,


gram) must be

prefixed with the


Presentation Upper

Range Denominator

Quantity

High Amount

Denominator Value

(PP.ACT.12)

1:1 Direct mapping

1:1 Direct mapping






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



and extracts the



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PMS

Data Element

XEVMPD/

XEVPRM Data

element


Art.57 rule

shall be stored at

Pharmaceutical Product level.


single input.

NOTE: XEVMPD must

have prefix values,


gram) must be

prefixed with the


1.2.7.2.4. Concentration Strength Block

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

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

Measurement the 'Presentation Strength Block' will be migrated as presented in the below table.

NOTE: In case the strength is available in of both 'Presentation' and 'Concentration' unit in PMS, the

Presentation block will be used for feedback loop in Art.57 database.

PMS

Data Element

XEVMPD/

XEVPRM Data

element


Art.57 rule

Concentration

Lower Range

Numerator Quantity

Low Amount

Numerator Value

(PP.ACT.3)

1:1 Direct mapping If Presentation block is

NOT populated, then

1:1 direct mapping

Concentration

Lower Range

Numerator Unit

Term ID

Low Amount

Numerator Unit

(PP.ACT.5)


NOT populated, then

1:1 direct mapping

Concentration

Lower Range

Denominator

Quantity

Low Amount

Denominator Value

(PP.ACT.6)


NOT populated, then

1:1 direct mapping

Concentration

Lower Range

Denominator Unit

Term ID

Low Amount

Denominator Unit

(PP.ACT.8)


NOT populated, then

1:1 direct mapping

Concentration

Upper Range

Numerator Quantity

High Amount

Numerator Value

(PP.ACT.9)


NOT populated, then

1:1 direct mapping



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PMS

Data Element

XEVMPD/

XEVPRM Data

element


Art.57 rule

Concentration

Upper Range

Numerator Unit

Term ID

High Amount

Numerator Unit

(PP.ACT.11)


NOT populated, then

1:1 direct mapping

Concentration

Upper Range

Denominator

Quantity

High Amount

Denominator Value

(PP.ACT.12)


NOT populated, then

1:1 direct mapping

Concentration

Upper Range

Denominator Unit

Term ID

High Amount

Denominator Unit

(PP.ACT.14)


NOT populated, then

1:1 direct mapping

Concentration

Quantity Operator

Term ID

Concentration

Type Code

(PP.ACT.2)


NOT populated, then

1:1 direct mapping

1.2.7.3. Reference Strength



Reference strength is applicable to active substances. Where an active substance is in the form of a

salt or hydrate, the reference strength must be expressed in terms of the mass [or biological activity in

International (or other) units where appropriate] of the active moiety (base, acid or anhydrous

material). In these situations, strength (quantitative composition level) and reference strength level

will be different in PMS.

Since information on Strength in XEVMPD is based on the information in the SmPC and in a number of

medicinal products Strength (quantitative composition) and Reference Strength will be identical (if the

active substance is not a salt/hydrate), strength from XEVMPD will be repeated with Strength and

Reference Strength. Any inconsistency needs to be amended during the enrichment process.



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Figure 25


PMS

Data Element

XEVMPD/ XEVPRM

Data element


Art.57 rule

Lower Range

Numerator

Quantity

Low Amount

Numerator Value

(PP.ACT.3)

1:1 Direct mapping

1:1 Direct mapping

Lower Range

Numerator Unit

Term ID

(Low Amount)

Numerator Prefix

(PP.ACT.4)

Low Amount

Numerator Unit

(PP.ACT.5)


available in (Low Amount)


and (Low Amount)

Numerator Unit (PP.ACT.5),

to map with an RMS term

from the UoM list.

1:1 Direct mapping



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


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



and Concentration,

the Presentation block

is automatically used



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PMS

Data Element

XEVMPD/ XEVPRM

Data element


Art.57 rule

for XEVMPD

population.

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



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


Upper Range

Numerator

Quantity

High Amount

Numerator Value

(PP.ACT.9)

1:1 Direct mapping If Presentation block

is NOT populated,

then 1:1 direct

mapping

Upper Range

Numerator Unit

Term ID

High Amount

Numerator Unit

(PP.ACT.11)


is NOT populated,

then 1:1 direct

mapping

Upper Range

Denominator

Quantity

High Amount

Denominator Value

(PP.ACT.12)


is NOT populated,

then 1:1 direct

mapping

Upper Range

Denominator Unit

Term ID

High Amount

Denominator Unit

(PP.ACT.14)


is NOT populated,

then 1:1 direct

mapping

1.2.8. Ingredient subject area

The rules and principles described in section 0

Active Pharmaceutical Product subject area, apply to the Ingredient subject area.

products management services (pms) - implementation of ... · obligations since 2012, into the iso...

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