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 Zambia Cosmetic Product Registration

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 Zambia Cosmetic Product Registration

COSMETIC REGISTRATION IN ZAMBIA

Regulatory Authority:

The Zambia Medicines Regulatory Authority (ZAMRA)

Link for RA:

https://www.zamra.co.zm/

Local regulation:

Who can register:  

  • Manufacture
  • Authorized Representative

Data to be communicated: 

An applicant who is not resident in Zambia shall appoint a local responsible person with power of attorney who shall be responsible for compliance to regulatory requirements with respect to cosmetics. An applicant shall be responsible for the product information in support of the application for Marketing Authorization and variations thereof.

An applicant shall apply as prescribed in the guideline that shall be accompanied by a product dossier that is presented in an electronic text selectable/editable PDF format which shall be submitted via the ZAMRA online portal. Where an application has product variants such as fragrance, colour or flavours, such variants shall be considered as different products and shall require separate applications. An Application for Grant of Marketing Authorisation of a Cosmetic shall comprise the following:

  • Cover letter from the applicant.
  • A duly completed and signed application form.
  • Proof of payment of the prescribed application fee.
  • At least two samples of the cosmetic packaged in the smallest commercial pack supplied with the intended consumer packaging labelled in English.
  • A duly completed checklist as set out in Annex 1 indicating the sections of the application that have been completed and the pages thereof.
  • Product dossier

 

Additional information:

Vigilance: A MAH shall put in place a vigilance system to monitor the quality and safety of a cosmetic placed on the Zambian market. The MAH shall ensure that modalities to provide routine reports to the Authority on any findings on the quality and safety of the product are in place. The MAH shall appoint a qualified person responsible for vigilance. 

Labelling of Cosmetics: The labelling requirements shall be as set out in the Guideline and shall meet the requirements of latest version of the ISO 22715 – Cosmetics — Packaging and labelling and Section 50 of the Competition and Consumer Protection Act No.24 of 2010 of the Laws of Zambia. All containers or packages packed with cosmetic products shall be labelled and marked in English, in indelible, easily legible, and visible lettering. In the event where there are two or more languages, the English language shall be primary. The following particulars shall appear on the primary packaging or the primary and secondary packaging, where applicable, of a cosmetic:

  • The name of the cosmetic
  • Product presentation
  • Indication(s)
  • Instruction(s) or direction(s)
  • Ingredient (s)

Quality analysis: Where necessary, samples of a cosmetic may be analyzed by the NDQCL against the claimed manufacturer’s specifications in accordance with the current available local Standards, quality specifications such as those prescribed by ISO and any relevant internationally recognized standards.

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