Page tree
Skip to end of metadata
Go to start of metadata



RegulatedAuthorization[edit | edit source]

Draft resource in build:

Relationship to other resources

Owning work group name[edit | edit source]

BR&R

Committee Approval Date:[edit | edit source]

6th May 2019 (earlier approval as "MedicinalProductAuthorization" 13th September 2017)

Contributing or Reviewing Work Groups[edit | edit source]

  • Pharmacy

FHIR Resource Development Project Insight ID[edit | edit source]

1367


Scope of coverage[edit | edit source]

Regulated items - those subject to local, regional or international legislation for their use - are subject to authorization procedures and outcomes.

These authorizations, and the items they relate to, need to be tracked and made available.

Regulatory systems keep full details of authorizations, and these may be referenced by other users to check the legal and usage parameters of a medicinal product, or a device.

In scope:

The item that is being authorized (e.g. reference to a product or device)

The holder (receiver) and the regulator (creator) of the authorization.

Type of authorisation - Marketing approval (or suspension), orphan drug approval, special uses for veterinary medication etc.

Status, e.g. pending, approved, withdrawn.

Location of applicability, local, regional, national etc.

Dates of application, granting, and associated dates such as special case initial periods, end dates, renewal dates etc.

The legal framework under which the authorisation was granted (e.g. EU CAP Centrally Authorised Product).


Resource appropriateness[edit | edit source]

There is an outstanding requirement to support the standardised exchange of detailed "Product" data, for regulatory and other use cases.

Regulators (EMA, FDA, and national "Competent Authorities"), as well as more local organisations, hospital and payer networks etc, need to record the legal authorizations that apply to medicinal products. This is a key focus of what organizations such as FDA and EMA do - they regulate and authorize the ability to make drugs available.

Expected implementations[edit | edit source]

EMA and European drug manufacturers, who have a requirement to submit to EMA (and already do so in a proprietary format). The EU wide system is currently being redeveloped to use FHIR, and this data is directly in scope.

FDA for Drug Submission (currently using SPL, which is not likely to change in the near term, but have expressed an interest in FHIR).

FDA for Pharmaceutical Quality (HL7 PSS approved, based on this resource, June 2019),

Content sources[edit | edit source]

The core basis for the resource is information currently used by FDA (as SPL) and the EMA EU XEVMPD data base (and XEVPRM XML messages).

Also, information gained from early stage implementation of this resources at EMA (2018, 2019), and from many many received to EMA about the draft API specification from the European medicines regulatory network (https://www.ema.europa.eu/en/about-us/how-we-work/european-medicines-regulatory-network).

Example Scenarios[edit | edit source]

Pharma companies submit details of new products to regulators, and include authorization details, which in turn may be updated by the regulators.

Pharmacies and prescribers can view and download this information for reference and integration with their systems. They may be able to see why a product was withdrawn for instance.

Specific use cases include:

Submission of products from drug companies and NCAs (National Competent Authorities - the national regulators) to regional regulators.

This is already implemented in Europe (by EMA and EU-wide stakeholders) with an earlier non-HL7 format (XEVPRM/XEVMPD). That scenario is currently being re-implemented, using this resource, as part of the EU wide SPOR project.

Resource Relationships[edit | edit source]

See diagram below.

Some notable resource references:

To Organization, for the licence holder and the regulator that established the authorization/licence.

To a MedicinalProductDefinition or PackagedProductDefinition (authorization can happen at different levels, per specific pack, or product wide), or a DeviceDefinition, as the subject, that is authorized.


Also refer to the logical model which was used to clarify the resource relationships, at the request of FMG, in the preparation of this proposal (linked to the approved MedicationKnowledge proposal page): MedicationKnowledge_FHIR_Resource_Proposal

High level relationships of the main prescribing resources and the regulatory strata below:

Relationship to other resources

Timelines[edit | edit source]

Draft content is modelled in the FHIR build (http://build.fhir.org/regulatedauthorization.html), with outline supporting documentation. Completion planned Q4 2019.

gForge Users[edit | edit source]

riksmithies

When Resource Proposal Is Complete[edit | edit source]

When you have completed your proposal, please send an email to FMGcontact@HL7.org

FMG Notes