Medical
Botany Research Services
We
at Medical Botany Research follow this APPLICATION PROCESS:
We
collect pertinent information from the client to determine the following:
§
Who is the
applicant, company officials, Canadian representative and contact information.
§
Is a Designated
Party Authorization Form required.
§
Application type:
compendial, non-compendial, traditional, non-traditional,
traditional DIN or homeopathic.
§
Are
ingredients medicinal or non-medicinal, acceptable or non-acceptable
ingredients.
§
Determine if
Animal Tissue is used in the product or process – if so, a separate form must
accompany the application.
§
Compile Monographs
and additional supporting evidence such clinical trials, on each product
ingredient.
§
Determine the
ratio of extract amount to crude dried material contained in each dose.
§
Write an Evidence
Summary document
§
Grading the
evidence and prepare a Levels of Evidence report
§
Prepare a Safety
and Efficacy Report
§
Report on the
purpose or use of product, dosages, limitation to use, proper and common names,
source material used, risk information, cautions, side-effects and
contraindications if known.
§
Create a label
displaying the pertinent product information, uses, doses, warnings, etc.
We
correct deficiencies and make the appropriate amendments to applications as
reported by the NHPD within the allowable 30 days to reapply for the NHP license
number.
Applicants
must submit balanced evidence from all relevant sources relating to the proposed
claim for the natural health product. There must also be a sufficient body of
sound, relevant evidence to support the other recommended conditions of use.
The
level of supporting evidence required for a treatment claim will increase as the
risk associated with the product increases.
The
NHPD may request additional information if they feel insufficient evidence is
provided.
All
relevant information, both favorable and unfavorable, must be included in the
Safety and Evidence Summary Reports.
We
work closely with you to insure confidentiality and a complete and successful
application.
