Dossier
Dossier for Herbal Products

I. Section A
II. Section B

I. Section A: Drug Substance
  • Drug Substance (Name, Manufacturer)
    Definition of the herbal product stock(s) and the herb name (s) should be provided. For herbal stocks of herbal origin for example:
    Binominal scientific name of plant (genus, species, variety and author) and chemotype (where applicable)
    Other names (synonyms)/ common names /latin names
    Reference of the herbal product manufacturing procedure
    Description of vehicles used
  • Manufacturer(s) (name and manufacturer)
    The name, address, and responsibility of each manufacturer, including manufacturer of stock, dilutions and/or triturations as well as, contractors, and each proposed production site or facility involved in manufacturing/collection and testing should be provided.
  • Description of Manufacturing Process and Process Controls (name and manufacturer)
    The description of the herbal product stock(s), intermediate dilutions and/or triturations and final dilution manufacturing process represents the applicant's commitment for the manufacture of the herbal stock(s) and final dilution. Information should be provided to adequately describe the manufacturing process and process controls. For example: A sequential procedural narrative of the manufacturing process should be submitted. The narrative should include, for example, quantities of raw materials, solvents/vehicles, reagents (if applicable), critical steps and the controls that are intended to result in the routine and consistent production of material(s) of appropriate quality. A flow chart of the manufacturing process should be included. For herbal stock(s) and final dilution reference should be made to the appropriate section of a herbal manufacturing procedure described in an official Pharmacopoeia. The different stages of the preparation of the herbal stock(s) and final dilution or any preliminary treatment or transformation operation must be sufficiently described to allow the assessment of the consistency of the quality. The material, processes and specific precautions (light, moisture, miscellaneous contamination, and temperatures) must be described.

    Nomenclature of the raw materials
    Description of the raw materials
    Supportive Data
  • Control of Critical Steps and Intermediates (name, manufacture)
  • Process validation and/or Evaluation (name, manufacture)
  • Manufacturing Process Development (name, manufacture)
    Reference to the manufacturing method of an official Pharmacopoeia shall be made.
  • Characterization (name, manufacturer)
  • Elucidation of Structure and other Characteristics (name, manufacturer)
    Conformation of structure based on e.g., synthetic route, spectral analyses, biological activity, purity and phytochemical characterisation should be provided, where relevant.
  • Impurities (name, manufacturer)
    Information on impurities originating from the raw material(s) or arising from the manufacturing process should be provided
  • Control of Drug Substance (name, manufacturer)
  • Specifications (name, manufacturer)
    The specifications for raw materials, the herbal stock(s) and final dilutions should be provided.

    If the raw material is described in a Pharmacopoeia, the reference to the monograph should be stated and, where applicable, supplementary tests should be described. If the aw material is not described in a Pharmacopoeia, the monograph should be compiled based on scientific data.
  • Analytical Procedures (name, manufacturer)
    Analytical procedures used for testing the raw material (s), the herbal stock(s) and final dilution should be provided.
  • Validation of Analytical Procedures
    Analytical validation information, including experimental data for the analytical procedures used for testing the raw material(s), herbal stock(s) and final dilution should be provided.
  • Batch Analysis (name, manufacturer)
  • Justification of Specifications (name, manufacturer)
    Justification for the raw material(s), herbal stock(s) and final dilution specifications should be provided.
  • Reference Standards or Materials (name, manufacturer)
    Information on the reference standards or reference materials used for testing raw material(s), herbal stock(s) and final dilution should be provided.
  • Container Closure System (name, manufacturer)
    Descriptions of container closure system(s) used for storage of the herbal stock(s), final dilution, intermediate dilution/trituration and raw materials (if stored) should be provided. The combination of the container closure specifications and the stock stability data may be sufficient to demonstrate suitability of the container closure system for storage and shipping of the stock.
  • Stability (name, manufacturer)

II. Section B: Drug Product
  • Drug Product (Name, Dosage Form)
  • Description and Composition of the Drug Product (name, dosage form)
  • Pharmaceutical Development (name, dosage form)
  • Components of the Drug Product (name, dosage form)
  • Drug Substance (name, dosage form)
  • Excipients (name, dosage form)
  • Drug Product (name, dosage form)
  • Formulation Development (name, dosage form)
    Where applicable, the differences between clinical formulations and formulation (i.e. composition) described in 3.2.P.1 should be provided.
  • Overages (name, dosage form)
  • Physicochemical and Biological Properties (name, dosage form)
  • Manufacturing Process Development (name, dosage form)
    Where applicable, differences with the manufacturing process(es) used to produce pivotal clinical batches clinical should be provided.
  • Container Closure Systems
  • Microbiological Attributes (name, dosage form)
  • Compatibility (name, dosage form)
  • Manufacture (name, dosage form)
  • Manufacturer(s) (name, dosage form)
  • Batch Formula (name, dosage form)
  • Description of Manufacturing Process and Process Controls (name, dosage form)
  • Controls of Critical Steps and Intermediates (name, dosage form)
  • Process Validation and/or Evaluation (name, dosage form)
  • Control of Excipients (name, dosage form)
  • Specifications (name, dosage form)
  • Analytical Procedures (name, dosage form)
  • Validation of Analytical Procedures (name, dosage form)
  • Justification of Specifications (name, dosage form)
  • Excipients of Human or Animal Origin (name, dosage form)
  • Novel Excipients (name, dosage form)
  • Control of the Drug Product (name, dosage form)
  • Specification(s) (name, dosage form)
  • Analytical Procedures (name, dosage form)
  • Validation of Analytical Procedures (name, dosage form)
  • Batch Analysis (name, dosage form)
  • Characterisation of Impurities (name, dosage form)
  • Justification of Specification(s) (name, dosage form)
  • Reference Standards or Materials (name, dosage form)
  • Container Closure System (name, dosage form)
    The combination of the container closure specifications and the drug product stability data may be sufficient to demonstrate suitability of the container closure system for storage and shipping of the drug product.
  • Stability (name, dosage form)
    Herbal medicinal products: if no identification or assay of the active substance is possible due to the degree of dilution, stability data of the pharmaceutical form may be considered
  • Stability Summary and Conclusions (name, dosage form)
  • Post-approval Stability Protocol and Stability Commitment (name, dosage form)
  • Stability Data (name, dosage form)
  • APPENDICES
    Facilities and Equipment (name, manufacturer)
    Adventitious Agents Safety Evaluation (name, dosage form, manufacturer)
    Novel Excipients
  • Literature references