Harmonised Technical Guidance for Non-eCTD electronic ...
NeeS is based on electronic Tables of Content, bookmarks and hypertext links. 2.2.1 Dossier Structure Typically, a NeeS application shouldcover all dosage forms a nd strengths of a product with any one invented name. In MRP/DCP, a single application should preferably be used for NeeS procedure (e.g. -H-1003).each If UK
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