In order to facilitate understanding, terms used in the guidelines are explained here and/or reference is made to relevant sections. This appendix provides supplementary information and is not a formal part of the Scheme.
For the sake of clarity, all definitions taken from the glossary of "Good manufacturing practices for pharmaceutical products" (1) are preceded by an asterisk.
abuse of Scheme
See sections 4.9 and 5.2 of the guidelines.
See sections 1.5, 4.4 and 4.5 of the guidelines.
addresses of competent authorities
See sections 2.2 and 3.3 of the guidelines.
The party applying for a Product Certificate. This is normally the product-licence holder. Because certain data are confidential for commercial reasons, the competent authority in the exporting country must always 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 section 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.
A document containing information, as set out in Appendix 3 of the guidelines, will normally be issued for each batch by the manufacturer. Furthermore, a batch certificate may exceptionally be validated or issued by the competent authority of the exporting country, particularly for vaccines, sera and other biological products. The batch certificate accompanies 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.
The competent authority that issues product certificates. It must ensure that it possesses the capacities listed in section 2.4 of the guidelines.
charges for product certificates
See section 3.11 of the guidelines.
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 section 2.1 of the guidelines). The competent authority can issue or receive certificates.
WHO makes available on 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 sections 2.4, 2.5 and 4.2 of the guidelines.
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 section 3.2 of the guidelines.
See section 3.2 of the guidelines.
importing agents, guidelines for
See section 3.4 of the guidelines.
language of product certificate
See section 3.10 of the guidelines.
An individual or a corporate entity possessing a marketing authorization for a pharmaceutical product.
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 certificate by competent authority
See sections 3.12 and 4.8 of the guidelines.
All operations of purchase of materials and products, production, quality control, release, storage, shipment of finished products, and related controls.
A company that carries out at least one step of manufacture. (For the different categories of manufacturer, see Appendix 1, explanatory note no. 7.)
See product licence.
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.
See pharmaceutical product.
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 section 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.
The approved product information referred to in section 4.7 of the guidelines and item 2A.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.
An official document issued by the competent drug regulatory authority for the purpose of the 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 the 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.
See licence holder.
All operations involved in the preparation of a pharmaceutical product, from receipt of materials, through processing and packaging, to completion of the finished product.
Any statutory system of approval required at national level as a precondition for introducing a pharmaceutical product on to the market.
See product licence.
See Appendix 3, explanatory note 7.
statement of licensing status
See section 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 of 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 section 4.6 of the guidelines.
See section 5.4 of the guidelines.
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).