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Guideline on stability testing for applications for variations
to a marketing authorisation for veterinary medicinal
products
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Table of contents
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Executive summary ..................................................................................... 5
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1.
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6.9.
- Change in concentration of a single-dose, total use parenteral product,
where the amount of the active substance per unit dose (i.e.
- (F.II.e.1.a.2) Change in immediate packaging of the finished product: Qualitative and
quantitative composition: Sterile medicinal products and biological/immunological medicinal
products................................................................................................................ 12
6.18.
- (F.II.e.1.b.2) Change in immediate packaging of the finished product: Change in type
of container or addition of a new container: Sterile medicinal products and
biological/immunological medicinal products ............................................................... 13
6.20.
- (F.II.e.5.b) Change in pack size of the finished product: Change in fill weight/fill
volume of sterile multidose (or single-dose) parenteral medicinal product, including
biological/immunological medicinal products ............................................................... 13
6.22.
- (I.I.1.f) Changes to the active substance(s): Change to the extraction solvent or the
ratio of herbal drug to herbal drug preparation where the efficacy/safety characteristics are
not significantly different ......................................................................................... 14
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6.25.
- Commitment batches ............................................................................. 15
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References ................................................................................................ 15
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Annex I ..................................................................................................... 16
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Annex II .................................................................................................... 16
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Executive summary
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This guideline provides guidance on the stability data which have to be generated in order to support a
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variation to a marketing authorisation for veterinary medicinal products.
- The guideline provides
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general guidance on stability testing for variations not requiring assessment (VNRA) and variations
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requiring assessment (VRA).
- Introduction (background)
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This guideline describes the stability testing requirements for variations to a marketing authorisation
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for veterinary medicinal products after approval.
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The guideline seeks to illustrate the stability data required for variations to active substances and/or
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finished products.
- It is applicable to chemical active substances and related finished products, herbal
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substances, herbal preparations and related herbal medicinal products for veterinary use.
- The
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Guideline provides general guidance on stability testing in case of variations requiring and not requiring
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assessment.
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The scope and design of the stability studies for variations and changes are based on the knowledge
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and experience acquired of the active substances and finished products.
- For active substances:
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?
the stability profile including the results of stress testing, if applicable (except herbals);
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?
the supportive data;
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the primary data of long term and accelerated* testing.
- These variations have different levels of
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complexity and thus supporting data for particular variations will depend on the exact nature of the
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change.
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6.5.
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6.9.
- modified release form) or when the active
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substance is known to be unstable, comparative stability data, 6 months in duration, under long term
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and accelerated* stability testing conditions, on at least three primary batches, are recommended.
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6.26.
- The stability testing protocol is as
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described in the original application unless it has previously been varied.
- For more detailed information on statistical evaluation of stability data
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please refer to the CVMP/VICH Guideline on Statistical Evaluation of Stability Data.
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