Introduction

Marketing authorization is a key concept in the IDMP standards and bundles the drug registration information and jurisdictional context. It relates a medicinal product not only to the jurisdiction in which it is authorized but also connects with with the manufacturing side of the business which is also an important bridge. Some of the key questions related to marketing authorization, including the roles related to being authorized for a specific set of investigations / clinical trials or more generally in a jurisdiction are covered in /wiki/spaces/IDMP/pages/7242078 and /wiki/spaces/IDMP/pages/7243867.

Relation to ISO-IDMP Standards

The following figure is taken from the ISO 11615 specification (Figure 7):

Figure 1. Marketing Authorization Detailed View

The image below proivdes a bit more context, extracted from the complete diagram in Annex A from ISO 11615.

Figure 2. Marketing Authorization in context

Modeling Patterns

Representing a Medicines Regulatory Agency

Medicines Regulatory Agencies play a number of roles – they are regulatory agencies, with oversight responsibility within some jurisdiction; they are registration authorities, responsible for registration within that jurisdiction, and they may also be authorizing parties (although in the EU that responsibility is based on a recommendation from the medicines regulatory agency to the European Commission).

The simpler case, whereby the medicines regulatory agency is also the authorizing party is shown in Figure 3.

Figure 3. Basic Medicines Regulatory Agency

Note that a legally competent natural person is a legal person, and a polity is a legal person, but neither is a legal entity. A regulatory agency is typically played by a formal organization that is also a legal person, but may be an instrumentality (legal person in its own right), government body, or other similar formal organization.

Representing Authorizations

An authorization is a situation in which some party authorizes another to act on their behalf or to have certain responsibilities or capabilities under certain circumstances for some period of time. The ISO IDMP standards cover a number of kinds of authorizations, such as an authorization to manufacture a product, to market a product, or to hold a clinical trial to investigate the efficacy of some product or procedure. the basic pattern for any sort of authorization is given in Figure 4.

Figure 4. Basic Authorization Pattern

Representing a Marketing Authorization

Putting the patterns shown in Figures 3 and 4 together to specify a marketing authorization, including the jurisdiction of the regulatory agency is modeled as follows.

Figure 5. Basic representation of a Marketing Authorization, with some details elided

Representing an Authorized Medicinal Product

In the context of the IDMP ontology, authorized medicinal product and investigational medicinal product are functional roles that a medicinal product can play rather than subclasses of medicinal product. The pattern for representing an authorized medicinal product extends the pattern specified in Figure 5 to include that authorized product.

Figure 6. Representing an Authorized Medicinal Product, with some details elided

Extending the Pattern for Packaged Medicinal Products

In the context of the IDMP ontology, a packaged medicinal product extends the definition of a medicinal product to include some package item. A packaged medicinal product may play the role of an authorized medicinal product through inheritance. The composite pattern, showing the extension, is given in Figure 7, below.

Figure 7. Representing a Packaged Medicinal Product

Pistoia Alliance IDMP Ontology

Pattern: Marketing Authorization - REVIEW