WHO Technical Report Series, No. 981 - World Health Organization

Annex 4
Appendix 4
Report on post-registration actions in respect of a
product registered under the Procedure
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Variation of the national registration resulting in the national
registration conditions being inconsistent with the WHO/PQP
prequalification conclusions
Deregistration or suspension of the registration of the product
Product details:
Product name in national system:
National registration number:
Date of registration (dd/mm/yyyy):
(“the Product”)
WHO prequalification details:
WHO prequalification reference number:
Date of prequalification (dd/mm/yyyy):
WHO prequalification holder:
The national variation procedure has resulted in the nationally-registered
Product being no longer the same 1 as the WHO-prequalified product.
Deviations 2
Reasons
1
Within the context of this Procedure, the same pharmaceutical product is characterized by the same
product dossier, the same manufacturing chain, processes and control of materials, the same API and FPP
specifications and the same essential elements of product information, as further described in paragraph
3.2 of the Procedure.
2
This refers to deviations in indications, contraindications, posology (dosing), special warnings and
precautions for use, adverse drug reactions, storage conditions and shelf-life. Differences in brand name,
name of applicant/prequalification holder, format of product information, level of detail of product
information, labelling of internal and external packaging and language of product information are not
considered to be a deviation from the prequalification conclusions.
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