[ HARMONIZER — NOT A MARKET ]
Publishes technical reports and prequalification standards that national authorities take up by reference rather than apply directly.
SPEQ synthesis for orientation. It does not determine what applies to a specific product, and an adopted version can move without this page moving with it. Confirm the instrument in force with the authority before relying on it.
INTERNATIONAL
None over any manufacturer. WHO is a United Nations specialised agency and its pharmaceutical quality standards are recommendations to Member States, published as annexes to the Technical Report Series of the Expert Committee on Specifications for Pharmaceutical Preparations — WHO GMP for pharmaceutical products appears as TRS 986 Annex 2, and WHO GMP for sterile pharmaceutical products as TRS 1044 Annex 2. A TRS annex is a recommendation until a national authority makes it national law.
Two distinct ways, and conflating them is the common error. First, by national adoption: many authorities, particularly where no domestic GMP code was written from scratch, adopt WHO TRS annexes into national regulation, at which point the requirement is national law carrying a WHO text. Second, by procurement: WHO Prequalification assesses products and manufacturing sites so that UN agencies and national procurers can buy against a single assessment. Prequalification is a purchasing qualification, not a marketing authorisation — a prequalified product still needs national registration wherever it is used.
WHAT TRANSFERS
More than most harmonizers, because WHO built instruments specifically for transfer. The Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce produces the Certificate of a Pharmaceutical Product, issued by the exporting country’s authority and stating the product’s regulatory status and the GMP status of its manufacturer — the document importing authorities most commonly ask for. Prequalification status also transfers as evidence. Neither confers market access: the CPP is an attestation an importing authority may rely on, and the decision remains that authority’s.
WHO guidance is published as numbered annexes to numbered reports, and both numbers matter — TRS 986 Annex 2 is a different document from TRS 1044 Annex 2. Citing “WHO GMP” without the report and annex leaves the reader unable to find the text or to know which revision was meant.
It exists so that global purchasers can rely on one assessment instead of many. It does not license a product for sale in any country, and a prequalified manufacturer still holds whatever national permissions each market requires.
WHO designed the scheme and the model format; the certificate itself comes from the national regulatory authority of the exporting country. Practitioners chasing a certificate from WHO are chasing a document WHO does not issue.
The WLA framework evaluates and publicly lists authorities meeting defined maturity and performance criteria, replacing the older procurement-oriented SRA designation. Documents and tender requirements still written in SRA terms are referring to a concept that has been superseded.
Only if your national authority has adopted it. WHO publishes GMP as annexes to the Technical Report Series — TRS 986 Annex 2 for pharmaceutical products, TRS 1044 Annex 2 for sterile products — and those are recommendations to Member States. Where an authority has brought an annex into national regulation, you are held to the national instrument.
No. Prequalification assesses products and manufacturing sites so UN agencies and national procurers can purchase against a single assessment. It is a procurement qualification, not a marketing authorisation, and a prequalified product still requires national registration in each country where it is used.
The national regulatory authority of the exporting country, using the model format set out in the WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce. WHO does not issue CPPs. The certificate states the product’s regulatory status and the GMP status of its manufacturer, and importing authorities commonly require it.
The WHO Listed Authority framework, which evaluates authorities against defined maturity and performance criteria and lists them publicly. It replaces the earlier, procurement-oriented SRA designation, so tender documents and procedures still written in SRA language are using a superseded concept.
ADOPTED, AT A PINNED VERSION
SPEQ has not decoded a pinned adoption edge here yet. That is a gap in this catalog, not a finding about WHO: requirements still arrive through the authorities that adopt this body’s output, and the edition in force is theirs to state.
SPEQ records no harmonizer participation for WHO. Requirements here are set by the authorities above rather than arriving through a harmonized guide, so evidence prepared for another market does not transfer on that basis.