Changes+from+SPL+Validation+Rules+v2+201005011423

Revisions in Validation Rules v 2.0 [Revision 201008021527]
Additions of text = __underline__ Deletions of text = strikethrough New requirement / renumbering = **bold**

Note: This rule replaces 1.6.2.2, 1.6.3.2, and 2.2.6.4 from the earlier version [201005011423]
 * NEW 1.1.11** If there is a confidentiality code, then the code is "B" and the codeSystem is "2.1.840.1.113883.5.25".


 * NEW 2.2.1.22** Generic medicine name contains no more than 512 characters.


 * PREVIOUS 2.2.1.22 now 2.2.1.23**


 * NEW 2.2.3.9** For percentages numerator unit is not 1, instead use a volume unit for volume fractions and a mass unit for mass fractions.

2.2.6.5 If there is a strength, then the rules are as above for active ingredients. Note: See rules 2.2.3.6, 2.2.3.8, and 2.2.3.9


 * CHANGE 2.3.4.1** If the document is not a UDI submission, then t There is a section with the code 51945-4 (principal display panel) with an image of the carton/container label.


 * NEW 2.3.4.4** If the document type is 34390-5 (Human OTC drug label) and the citation is not part 352(sunscreens), then there must be the following sections: 55106-9 (OTC-active ingredient section), 55105-1 (OTC-Purpose section), 50565-1 (OTC-Keep out of reach of children section), 34067-9 (Indications & Usage section), 34071-1 (Warnings section), 34068-7 (Dosage & Administration section), and 51727-6 (Inactive ingredients section).