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H
ome
(ALT-H)
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M
A Joint
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u
man Medicines
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e
ads of Agencies
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C
MDh
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3.3:
M
R
I Product Index
(ALT-R)
3.4:
D
i
rectory
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V
eterinary Medicines
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Human Medicines
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CMDh
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Procedural Guidance
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Variation
> Art 5 recommendations
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Art
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6
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Art.5 on Unforeseen Variations
Timetables 2012 for request to CMDh for a recommendation on the classification of an unforeseen variation - Article 5
(September 2011)
For the
template of the Article 5
, please refer to
Variations
CMDh Recommendation for classification of unforeseen variations according to Article 5 of Commission Regulation (
EC
) 1234/2008
(October 2011)
CMDv Recommendations for Classification of Unforeseen Variations according to Article 5 of Commission Regulation (
EC
) 1234/2008
