Essential medicines and health products

Guidelines on the implementation of the WHO certification scheme on the quality of pharmaceutical products moving in international commerce


Glossary

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 the WHO Technical Report Series No. 823, 1992 are preceded by an asterisk.

Abuse of scheme: (see item 4.9 and 5.2 of Guidelines)

Active ingredients: (see item l.5, 4.4 and 4.5 of Guidelines)

Addresses of competent authorities: (see item 2.2 and 3.3 of 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 item 3.14 of 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 Guidelines)

Competent authority: This is 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 competent authority can issue or receive certificates. The extent of participation should be indicated in the letter of acceptance. (see item 2.1 of the Guidelines) 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 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 Guidelines)

GMP certificate: (see item 3.2 of Guidelines)

Importing agents, guidelines for: (see item 3.4 of Guidelines)

Language of product certificates: (see item 3.10 of 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, the publicity, the pharmacovigilance, the surveillance of batches, and if applicable of their withdrawal, for a pharmaceutical product, whether or not it be the holder of the marketing authorization.

Limits of certification by competent authority: (see item 3.12 and 4.8 of 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 categories of manufacturer see Appendix 1, Explanatory Note No. 7)

Marketing authorization: (see product licence)

Pharmaceutical product: Any medicine intended for human use or veterinary product 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)

Product information: This is 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, Batch Certificate, footnote 7.

Statement of licensing status: (see item 3.13 of Guidelines and Annex 2)

Summary Basis of Approval: This refers to the document prepared by some national regulatory authorities, that summarizes the technical basis on which the product has been licensed. (see item 4.7 of Guidelines and explanatory note 9 of the product certificate contained in Annex 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 Guidelines)

Transmission of product certificate: (see item 3.8 and 4.9 of Guidelines)

Validity of product certificate: (see item 3.9 of Guidelines)

When to request a product certificate: (see item 3.5 of Guidelines )

WHO responsibility: (see item 5.4 of Guidelines)

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