In the design of computer applications a number of assumptions and choices need to be made with regard to terminology and format of information. The following definitions are those that have been used in the design and development of the WHO model system. Although they are derived from work with national authorities, the choice of terms is to a large extent arbitrary, and this list should not be seen as a recommendation to adopt them. These concepts are presented only for sake of clarity and with the understanding that terms routinely used by national regulatory authorities have considerably different meanings in different parts of the world. Please see the glossary in Annex 5 for additional terms.
In this manual, the issuance or denial of a marketing authorization is the result of the drug registration or licensing process. |
Application for marketing authorization An application generally consists of a number of documents regarding quality, efficacy, and safety of the product gathered in a file, often called an application dossier. Dossiers have different contents depending on national requirements, the nature of the drug for which a marketing authorization is sought, and the capability of the applicant to assemble a complete set of information. Each application for marketing authorization is given a number, by the regulatory authority, called the application number.
The elements that make an application unique in a software system are:
• A company responsible before the national authorities for all the implications that can arise from product marketing (this company is called marketing authorization holder, or licence holder, it is not necessarily the manufacturer)
• A product name (either a generic name or a trademark)
• A dosage form
• One or more active ingredients and their quantities
• A primary container
• A manufacturer (this is the manufacturer of the finished product responsible for releasing it for distribution)
A change in any of these elements should require a different application number. In a computerized system the application number can be automatically generated by the computer or can be entered by a user who has the appropriate rights.
Application for variation to marketing authorization: An application for changing selected information related to an existing, valid marketing authorization (MA). Depending on established regulations, the type and extent of variations permitted vary from country to country; variations admitted in some countries entail, elsewhere, issuance of a new marketing authorization and cancellation of the previous one. To accommodate such a variety of requirements, the registration software should permit recording variation of all marketing authorization data except the number and validity date. In all cases the history of variations must be recorded.
Application for marketing authorization renewal: An application for extending the validity of an existing marketing authorization that has been issued for a given time period.
Application processing steps: A processing step is any event in the processing of an application characterized by a date on which the event starts or is expected to start, a technical or operational decision, a date on which such decision is made, and an assessment report. The WHO software system is designed to permit users to define as many different steps and sub-steps as required.
By making proper use of this feature, users will be able to trace applications and know their status at any time during processing. They will also be able to produce statistics on the duration of assessment as a whole or by step. However, the use of this feature is not obligatory. Regulatory authorities with very limited staff do not usually have difficulty in tracing pending applications. They can ignore this feature of the software system.
Generic Name: generic names are also called common names for pharmaceutical substances or, when available, INNs or modified INNs. In a computerized system, information on substance names can be entered in two separate database fields:
1) fields describing the composition, called “ingredient name fields.” In these fields, substance names are entered specifying the exact form, e.g., chloroquine phosphate.
2) a field indicating only the active part of the molecule used to prepare the dosage form, e.g., chloroquine. This field will contain chloroquine for all products containing any salt of chloroquine, regardless of dosage form or strength. This field is called the “generic name field,” referring to the active component. Two drug products may have the same generic name but have different ingredient names, dosage forms, and strengths.
To use this concept of generic name in the context of computer-assisted drug registration, the following principles apply:
Drug products with only one active ingredient |
The generic name is the name of the base that constitutes the active ingredient, regardless of the form used in the formulation, unless a specific salt has unique therapeutic uses unrelated to those of the base. For example, the generic name ampicillin applies to all drugs containing either ampicillin trihydrate, ampicillin sodium, ampicillin hydrochloride, etc. This simplification applies only to the generic name field of an application. It does not limit the possibility for users to record the full name and quantity of the active substance(s) in the ingredient fields. Thus, searches can be based on either the generic name or the individual full substance names of the ingredients. |
| |
|
Drug products with two active ingredients |
The generic name reflects the names of the base that constitutes the two active ingredients regardless of the form used in the formulation, unless a specific salt has unique therapeutic uses unrelated to those of the base. These two names need to be entered in the same field. It is therefore recommended that, to avoid repetitions, a fixed format is used to enter them. For example, one could use a plus sign to separate the two names and enter them always in alphabetical order: e.g. amoxycillin + clavulanic acid instead of clavulanic acid + amoxycillin. |
| |
|
Drug products with more than two active ingredients |
Building a generic name by adding those of several individual components is not practical. In addition, a rational drug rarely has three or more active ingredients. The proposed approaches are these: 1) enter, in the generic name field, the same predefined term for all drugs, e.g., combination, see composition, or 2) enter an arbitrary term to indicate a loosely homogeneous group, and use a predefined term for those drugs for which a homogeneous group is not easily identified, e.g., multivitamin, minerals, minerals + multivitamin, electrolytes, electrolytes + glucose, cold preparation, combination, see composition. |
Marketing authorization An authorization by a competent drug regulatory authority for a product to be placed on the market for sale or to be made available to the general public free of charge. In some countries it is called product licence, or simply, licence. Each marketing authorization has a number called the marketing authorization, registration, or license number. The marketing authorization is made unique by all of the elements described in its application.
Chargement en cours...
