Reconstitution is not mixing several ingredients, including the active substance, together to produce the investigational medicinal product.
Pharmaceutical dossier definition trial#
“The reconstitution is understood as the simple process of dissolving or dispersing the investigational medicinal product for administration of the product to a trial subject, or diluting or mixing the investigation medicinal product with some other substance(s) used as a vehicle for the purpose of administering it to a trial subject. This process has to be defined in the clinical trial application / IMP dossier and clinical trial protocol, or related document, available at the site.ĭetailed Commission guidelines on good manufacturing practice for investigational medicinal products for human use (“Updated Annex 13”): The process of reconstitution has to be undertaken as soon as practicable before administration.” Reconstitution is not mixing several ingredients, including the active substance, together to produce the investigational medicinal product.Īn investigational medicinal product must exist before a process can be defined as reconstitution. or, diluting or mixing the investigational medicinal product(s) with some other substance(s) used as a vehicle for the purposes of administering it,.dissolving or dispersing the investigational medicinal product for administration of the product to a trial subject,.For the purpose of this provision, reconstitution shall be understood as a simple process of: This authorisation, however, shall not be required for reconstitution under the conditions set out in Article 9(2) Directive 2005/28/EC. “Manufacturing authorisation and reconstitutionīoth the total and partial manufacture of investigational medicinal products, as well as the various processes of dividing up, packaging or presentation, is subject to the authorisation referred to in Article 13(1) Directive 2001/20/EC, cf. EU GMP Annex 13 in Eudralex Volume 4 provides guidance on this as follows: The most common query we receive relates to deciding if an activity should be considered as manufacture or reconstitution.
Pharmaceutical dossier definition update#
As there have been some changes since this was published, including the introduction of an import oversight process for QP certified IMPs into Great Britain from approved countries, we thought it would be beneficial to review and update this blog.
We previously published this ‘frequently asked questions’ blog related to manufacture and supply of IMPs back in 2016, and it was based on an original publication on the earlier MHRA website. GMP and GCP Inspectors work closely with MHRA Clinical Trials and regularly provide support to help answer a wide range of stakeholder queries which relate to the manufacture, import, labelling, licencing requirements and general handling of Investigational Medicinal Products (IMPs).
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