guidelines on variations to a registered pharmaceutical product

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Guidelines on Variations to a Registered Pharmaceutical ProductDescription of changeConditions tobe fulfilledDocumentationrequiredReportingtype44 Change in the package size involving:44a44bchange in the number of units (e.g. tablets,ampoules etc.) in a packagechange in the fill weight/fill volume of nonparenteralmultidose productsConditions to be fulfilled1-2 1-3 IN1-2 1-3 Vmin1. The change is consistent with the posology and treatment duration accepted in the SmPC.2. No change in the primary packaging material.Documentation required1. Justification for the new pack-size, indicating that the new size is consistent with the dosage regimenand duration of use as accepted in the SmPC.2. A written commitment that stability studies will be conducted in accordance with NDA <strong>guidelines</strong> forproducts where stability parameters could be affected.3. Samples of the productDescription of changeConditions tobe fulfilledDocumentationrequiredReportingtype45 Change in the shape or dimensions of the container or closure for:45 a non-sterile FPPs 1-2 1-3 IN45 b sterile FPPs 1-2 1-4 VminConditions to be fulfilled1. No change in the qualitative or quantitative composition of the container and/or closure.2. The change does not concern a fundamental part of the packaging material, which could affect thedelivery, use, safety or stability of the FPP.Documentation required1. Samples of the product.2. Information on the proposed container-closure system (e.g. description, materials of construction,specifications etc.).3. In the case of a change in the headspace, a change in the surface/volume ratio or a change in thethickness of a packaging component: stability summary and conclusions, results for a minimum oftwo batches of pilot or production scale, of three (3) months of accelerated (and intermediate, asappropriate) and three (3) months of long-term testing and where applicable, results of photo stabilitystudies.Doc. No.: DAR/GDL/005 Revision Date: 8 th July 2013 Review Due Date: 16 th July 2016Revision No.: 1 Effective Date : 16 th July 2013 Page 52 of 70
Guidelines on Variations to a Registered Pharmaceutical Product4. Evidence of revalidation studies in the case of terminally sterilized products. The batch numbers of thebatches used in the revalidation studies should be indicated, where applicable.5. Label artwork (in colour)Description of changeConditions to befulfilledDocumentationrequiredReportingtype46 Change in qualitative and/or quantitative composition of the immediate packaging material for:46a solid FPPs 1-3 1-3 IN46b semisolid and non-sterile liquid FPPs 1-3 1-3 Vmin46c46dSterile medicinal products andbiological/immunological medicinalproductsThe change relates to a lessprotective pack where there areassociated changes inn storageconditions and/or reduction in shelf lifeConditions to be fulfilled1. The change does not concern a sterile FPP.2. No change in the packaging type and material (e.g. a different blister, but same type).VmajorVmajor3. The relevant properties of the proposed packaging are at least equivalent to those of the currentlyaccepted material.Documentation required1. Data demonstrating the suitability of the proposed packaging material (e.g. extractable/leachabletesting, light transmission, permeation testing for oxygen, carbon dioxide, moisture etc.).2. Information on the proposed packaging material (e.g. description, materials of construction,specifications etc.).3. Stability summary and conclusions, results for a minimum of two batches of pilot or production scale,of three (3) months of accelerated (and intermediate, as appropriate) and three (3) months of longtermtesting and where applicable, results of photo stability studies.Doc. No.: DAR/GDL/005 Revision Date: 8 th July 2013 Review Due Date: 16 th July 2016Revision No.: 1 Effective Date : 16 th July 2013 Page 53 of 70
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guidelines on variations to a registered pharmaceutical product

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