This model dossier (MD) is intended primarily as a training tool for regulators, but may also be used by applicants as guidance for dossier submissions to PQTm, and as an example for organizations involved in harmonizing regulatory requirements. For more details see the Introduction to the Model Dossier.
Although efforts were made to provide QIS/QOS-PD templates and associated Module 3 data that are as complete as possible, the MD may include inconsistencies and inaccuracies that would not be accepted in a final dossier.
The MD is not a guideline on prequalification and/or regulatory requirements. Thus, the inclusion of data in the MD does not imply that these data are or should be considered acceptable for prequalification and/or regulatory purposes.
In using the MD during training exercises, regulators/trainers should apply their own standards and requirements to the assessment of the data. Furthermore, use of the MD in training exercises does not mean that trainees will be qualified to assess dossiers or certain parts thereof for regulatory compliance.
The MD does not reflect all the requirements for dossier submissions to PQTm. Requirements for the review of a dossier are specific to each submission with due consideration given to the specific dosage form, duration of treatment, previous experience with related dossiers, and other relevant factors. Use of the MD in the compilation of a dossier does not imply that such a dossier will actually (i) be accepted by PQTm and/or a national regulatory authority; and/or (ii) be considered adequate to support prequalification or any national regulatory approval of the product.
The MD does not necessarily include all the data that are required for the prequalification or regulatory approval of a product, nor does the inclusion of data in the MD imply that such data are required for review and approval by PQTm and/or national regulatory authorities. A dossier must include suitable and sufficient information to support the safety, efficacy and quality of the product. Applicants should refer to the current WHO PQTm guidelines (see the PQTm website at
http://www.who.int/prequal) in order to familiarize themselves with the WHO PQTm requirements for a particular product.
The versions of the QIS and QOS-PD templates in the MD will be superseded in due course; the current versions of the templates are required to be included with a dossier submission and are available at the PQTm website.
The MD is being published by WHO without any warranty or representation, either express or implied, including but not limited to any warranty or representation that:
- i. the MD is fit for any or all of its intended purposes; and/or that
- ii. the format and/or content of the MD:
- is accurate, complete and/or up to date; and/or
- reflects the requirements of PQTm and/or national regulatory authorities for the prequalification/national regulatory approval of a product in any or all respects.
While the MD is an example dossier, PQTm and/or national regulatory authorities may impose more, fewer and/or different requirements in respect of actual submissions. Users should not therefore rely on the MD as the only resource in training regulators, submitting a dossier to PQTm or harmonizing regulatory requirements, as the case may be.
WHO shall not be responsible and assumes no liability for any damages arising from the use of or reliance on the MD, its format and/or content.