Guidelines on Registration of Import of Cosmetics

Guidelines on Registration of Import of Cosmetics

  1. As per Rule 21 of the Drugs & Cosmetics Rules, 1945, every cosmetic product, being imported for sale in India, needs to be registered with the licensing authority

 2. The Import registration has to be applied in Form-42 Proforma along with the required and relevant documents and should be presented to the Cosmetics Division Incharge, Office of the Drugs Controller General of India, Central Drugs Standards Control Organization, FDA Bhawan, Kotla Road, New Delhi- 110002, India

  3. The Manufacturer, who has a registered office in India, any Subsidiary of the manufacturer or the Authorized Representative/ Agent of the manufacturer or the importer can apply for the Import Registration of Cosmetics.

  4. The Cosmetic 'Brand', as referred under the Act, means each of the cosmetic products which are being mentioned under the 3rd column of the list [see Annexure list].

  5. A 'Brand' will give umbrella cover to all the different variants of the product i.e. pack sizes, shades, color etc.

• • 6. A 'Brand' doesn't imply the trade-name of the manufacturer or of any of the manufacturer's cosmetics.
  • 7. The term 'manufacturer' implies an entity or a person in a country (other than India) who is the owner of the brand / trade name of the cosmetic product for which the registration is sought; one who manufactures the cosmetic product at his owned manufacturing site; one who manufactures the cosmetic product at another manufacturer's site but under his brand / trade name.
  • 8. The 'Authorized Agent' is an entity or the person who is authorized by the manufacturer to conduct regulatory activities / registration of cosmetic products being imported into the country as part of amendment to the Drugs and Cosmetics Rules, 1945
  • 9. 'Subsidiary' is a term allocated to a business entity in India that is under ownership of the manufacturer
  • 10. 'Other importer' signifies any entity or person which/ who proposes to import the cosmetic brand in India, other than the manufacturer, his subsidiary or its authorized representative
  • 11. The registration application should come along with the specified registration fee and an undertaking under Schedule D-III.
  • 12. Only one application needs to be submitted under form-42 for one or more number of the cosmetic brands, being manufactured at one or more manufacturing sites, but for a single manufacturer [under whose name the registration is sought].
  • 13. A Registration Certificate would be issued under form-43 for the applicant for importing any number of brands, being manufactured at more than one locations, but for a single manufacturer [under whose name the registration is sought].
  • 14. The Registration application should be submitted along with the specified fees of U.S. $250 or its similar value in Indian rupee, for each brand of cosmetics as listed in the 3rd column [see Annexure list].
  • 15. In case, registrations are sought for the same brand but for different manufacturers, then separate application forms need to be filled for each of the manufacturers and the registration fees will need to be paid separately.
  • 16. In case, the applicant wishes to add more brands to its existing list of registered category as shown in the 3rd column of the annexure, then a separate application has to be made and no further fee would be charged. The permission on product registration would be acknowledged on the existing RC 'Registration Certificate' in the already approved category.
  • 17. The power vested by the manufacturer in the Indian Authorized Representative would be documented on the 'Power of Attorney'. It is mandatory that the Power of Attorney is authenticated or executed in the presence of a Class-I Magistrate or an equivalent authority in the manufacturer's country of origin; or the document gets attested by the Embassy of India in the said country; or an Apostle from one of the member countries of Hague convention is also acceptable.

Note: the original copy of the document should be sent along with the application for the product's registration.

 For more information visit @ https://www.youtube.com/watch?v=MW9GOQhQaVk.

Source : articlesbase.com