top of page
Mancha-1.png
REGISTRY-PSU.png

Health

Cosmetics

Nutritional Supplements

Medical Divices

Generics

New Molecule

Vitamin Drugs

Biologic /

Bio-technological

Mancha.png
Foco-verde.png

VITAMIN DRUGS

Definition: A vitamin drug is one whose formulation exceeds the limits authorized to be considered as a nutritional supplement or whose combination does not meet the characteristics of a product that supplements the diet.

vitamindrugs-psu.png

ADVANTAGES OF REGISTRATION AS A VITAMIN DRUG VS A SUPPLEMENT

  • More labeling freedom

  • Better presentation in the medical world

  • Advertisement benefits

  • Possibility of patent

Requirements:

ADMINISTRATIVE - LEGAL INFORMATION: (MODULE I)

  • Manufacturing license

  • Certificates of good manufacturing practice for raw materials and finished products or equivalent

  • Free sales certificate or equivalent

  • Authorization or representation letter

  • Certificate of raw materials analysis

  • Pharmacology background in other countries

QUALITY INFORMATION

  • Drug formulation

  • Quality controls

  • Specifications

  • Analytical methods and validations

  • Analysis certification

  • Information on additives

  • Description of the manufacturing process (flow, process and controls)

  • Cover pages, manufacturing and conditioning orders for stability lots

  • Stability studies as per the Mexican regulation

BIBLIOGRAPHY (MODULE III)

Recent scientific, medical and technical bibliography to justify safety and efficiency; must be specific in:

a) The pharmaceutical form

b) Therapeutic indication

c) Group, ages to which the product is directed

d) Dose justification or clinical - preclinical studies

PRE-CLINICAL - CLINICAL STUDIES: (MODULE IV & V)

Pills5.png
Pills-Fondo.png
Mancha.png
Foco-verde.png
bottom of page