Cosmetics Product Dossier.

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Cosmetics Product Dossier

Cosmetics-Registration-in-India.com

The dossier on cosmetic products, also referred to as the ‘Product Information File’ contains detailed information on the products, some of which are :

  • The technical description of the products including the information on labeling and packaging
  • The composition / ingredients list in detail
  • Data on every raw material (content) including the details on additives and the contaminants, if any.
  • Details on GMP ‘Good Manufacturing Practices’
  • PSA report ‘Product Safety Assessment’
  • Justification of Best Period After Opening (PAO) and stability of the cosmetic product.
  • Documents pertaining to scientific claims
  • Report on Cosmetovigilance – post marketing data on health related surveillance that shows any undesirable health hazard / effects pertaining to the use of the cosmetic product
  • Assistance with the preparation and maintenance of the product dossier that complies with the regulatory requirements

Followup on the cosmetics product dossier

If the competent authority of CDSCO makes any request to make any supportive document on the Cosmetic Product Dossier available to them then the submission has to be made within a reasonable time period.

It is to be noted by the overseas manufacturer / exporter that the dossier and its information contents should not be older than a year and should comply to the standards specified in the Drugs and Cosmetics Act.

Disclaimer:

All the information on various aspects of Cosmetics Registration process and regulations in India is the personal interpretation of the author as gathered from various online & offline source materials. None of the information on this site, in part or whole, is claimed to be an authoritative opinion or summary extract of any law or regulations ; readers are requested to validate the information from their own informed sources and act so on their own wise decision.

Resources:

  • The Drug & Cosmetics Act, 1940
  • Drug Controller of India, Ministry of Health, Government of India
  • Ministry of Finance, Government of India
  • Reserve Bank of India

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