If the RLD is less than 17 mm in its largest dimension, the generic product should be:
o No more than 20 percent larger than the RLD in any single dimension (the resulting single dimension of the generic should not exceed 17 mm).
o No more than 40 percent larger than the volume of the RLD.
 • If the RLD is equal to or greater than 17 mm in its largest dimension, the generic product should be:
o No larger than the RLD in any single dimension.
o No larger than the volume of the RLD.
We recommend that the largest dimension of a tablet or capsule should not exceed 22 mm and that capsules should not exceed a standard 00 size.

Additional flexibility may be given for products that are 8 mm or smaller in their largest dimension, but efforts should be made to develop tablets and capsules that are of a similar size and shape to the RLD.

Under the standard capsule size convention, the allowances described above will generally allow an increase of one capsule size, when the RLD capsule is of size 3 or smaller. When the RLD capsule is of size 2 or larger, an increase of one capsule size should only be considered when adequate justification can be provided for the size increase. These recommendations would allow an increase of one capsule size when the capsule size is less than capsule size 00.

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