In order to facilitate understanding, this glossary explains terms in the Guidelines and/or refers to relevant sections. It is considered as supplementary information and not as being a formal part of the Scheme.

For clarity, all definitions that have been taken from the glossary of “Good manufacturing practices for pharmaceutical products” (1) are preceded by an asterisk.

abuse of Scheme

See item 4.9 and 5.2 of the guidelines

active ingredients

See item l.5, 4.4 and 4.5 of the guidelines

addresses of competent authorities

See item 2.2 and 3.3 of the guidelines

applicant

The party applying for a Product Certificate. This is normally the product licence holder. In all instances, having regard to commercial confidentiality of certain data, the competent authority in the exporting country must obtain permission to release these data from the product licence holder, or, in the absence of a product licence, from the manufacturer.

authentication of certificates

See item 4.9 of the guidelines

*batch (or lot)

A defined quantity of a starting material, packaging material, or product processed in a single process or series of processes so that it can be expected to be homogeneous. In the case of continuous manufacture, the batch must correspond to a defined fraction of the production, characterized by its intended homogeneity. It may sometimes be necessary to divide a batch into a number of sub-batches, which are later brought together to form a final homogeneous batch.

batch certificate

A document containing information, as set out in Annex 3 of the Guidelines for use, will normally be issued for each batch by the manufacturer. Furthermore, exceptionally a batch certificate may be validated or issued by the Competent authority of the exporting country, particularly for vaccines, sera and other biological products. The batch certificate travels with every major consignment (see also section 3.14 of the guidelines).

*batch number

A distinctive combination of numbers and/or letters which specifically identifies a batch on the labels, the batch records, and the certificates of analysis, etc.

*bulk product

A product that has completed all processing stages up to, but not including, final packaging.

certifying authority

This is the competent authority that issues product certificates. It shall ensure that it possesses the capacities listed in item 2.4 of the Guidelines.

charges for product certificates

See item 3.11 of the guidelines.

competent authority

The national authority as identified in the formal letter of acceptance in which each Member State informs WHO of its intention to participate in the Scheme. The extent of its participation should be indicated in the letter of acceptance (see item 2.1 of the guidelines). The competent authority can issue or receive certificates.

WHO makes available upon request a continuously updated list of addresses of competent authorities and, when applicable, the specific conditions for participation.

competence and evaluation of national authority

See item 2.4, 2.5 and 4.2 of the guidelines.

dosage form

The form of the completed pharmaceutical preparation, e.g. tablet, capsule, elixir, suppository.

drug regulatory authority

An authority appointed by the government of a Member State to administer the granting of Marketing Authorizations for pharmaceutical products in that country.

*finished product

A product that has undergone all stages of production, including packaging in its final container and labelling.

free sale certificate

See item 3.2 of the guidelines.

GMP certificate

See item 3.2 of the guidelines.

importing agents, guidelines for

See item 3.4 of the guidelines.

language of product certificates

See item 3.10 of the guidelines.

licence holder

An individual or a corporate entity being in the possession of a marketing authorization of a pharmaceutical product.

licensee

An individual, or corporate entity responsible for the information and publicity on, and the pharmacovigilance and surveillance of batches of, a pharmaceutical product and, if applicable, for their withdrawal, whether or not that individual or corporate entity is the holder of the marketing authorization.

limits of certification by competent authority

See item 3.12 and 4.8 of the guidelines.

lot

See batch.)

*Manufacture

All operations of purchase of materials and products, production, quality control, release, storage, shipment of finished products, and related controls.

*Manufacturer

A company that carries out at least one step of manufacture. (For the different categories of manufacturer see Appendix 1, explanatory note No. 7)

Marketing authorization

See product licence.)

pharmaceutical product

Any medicine intended for human use or administered to food-producing animals, presented in its finished dosage form or as an active ingredient for use in such dosage form, that is subject to control by pharmaceutical legislation in both the exporting state and the importing state.

product

See pharmaceutical product.)

product certificate

A document containing the information as set out in Appendix 1 of the guidelines that is validated and issued for a specific product by the competent authority of the exporting country and intended for use by the competent authority in the importing country or - in the absence of such an authority - by the drug procurement authority. (see also item 3.5 of the guidelines).

Transmission of product certificate: see sections 3.8 and 4.9 of the guidelines.

Validity of product certificate: see section 3.9 of the guidelines.

When to request a product certificate: see section 3.5 of the guidelines.

product information

The approved product information referred to in item 4.7 of the guidelines and item 2.A.5 of the Product Certificate. It normally consists of information for health professionals and the public (patient information leaflets), as approved in the exporting country, and when available, a data sheet or a Summary of Product Characteristics (SPC) approved by the regulatory authority.

product licence

An official document issued by the competent drug regulatory authority for the purpose of marketing or free distribution of a product. It must set out, inter alia, the name of the product, the pharmaceutical dosage form, the quantitative formula (including excipients) per unit dose (using International Nonproprietary Names or national generic names where they exist), the shelf-life and storage conditions and packaging characteristics. It also contains all information approved for health professionals and the public (except promotional information), the sales category, the name and address of the licence holder, and the period of validity of the licence.

product licence holder

See licence holder.)

*production

All operations involved in the preparation of a pharmaceutical product, from receipt of materials, through processing and packaging, to completion of the finished product.

registration

Any statutory system of approval required at national level as a precondition for introducing a pharmaceutical product onto the market.

registration certificate

See product licence.

specifications

See Appendix 3, explanatory note 7.

statement of licensing status

See item 3.13 of the guidelines and Appendix 2)

Summary Basis of Approval

The document prepared by some national regulatory authorities that summarizes the technical basis on which the product has been licensed (see section 4.7 of the guidelines and explanatory note 9 of the Product Certificate contained in Appendix 1).

Summary Product Characteristics (SPC)

Product information as approved by the regulatory authority. The SPC serves as the basis for production of information for health personnel as well as for consumer information on labels and leaflets of medicinal products and for control of advertising (see also Product information).

tenders and brokers

See item 4.6 of the guidelines.

WHO responsibility

See item 5.4 of the guidelines.

Reference

1. WHO Expert Committee on Specifications for Pharmaceutical Preparations. Thirty-second report. Geneva, World Health Organization, 1992: 18-22 (WHO Technical Report Series, No. 823).