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To All Importers of Cosmetic Products,

All importers of Cosmetic Products are hereby informed to submit their application and additional details for Sample Import License of Cosmetics to the dossier accepting point,only on Wednesday at NMRA Norris Canal Road Office effective from 01st of February 2023.

Required documents for the Sample Import License Application

  • Application form
    Business Registration Certificate
    Valid Original Letter of authorization (as a Sole Agent LOA or Tabulated LOA)
    Declaration from the manufacturer stated no more Importers registered in Sri Lanka.
    Declaration from the importer.
    Product label (Art work/Scanned commercial label)

Application for Sample license of Cosmetics for Test/Registration Purposes

නිවේදනයයි.

සියළුම සමාගම් නියෝජිතයින් වෙත.

ලියාපදිංචියෙන් නිදහස් කිරීමේ ලිපි සඳහා අයදුම් කිරීම/ අනුමැතිය ලබා දීමට අදාලව ගාස්තු අයකිරීම සම්බන්ධවයි.

ජාතික ඖෂධ නියාමන අධිකාරියේ 2023.01.25 දින නිකුත් කරන ලද අභ්‍යන්තර චක්‍රලේඛය අනුව එදින සිට ලියාපදිංචියෙන් නිදහස් කර ගැනීමේ ලිපි :(WOR) සඳහා ගාස්තු අයකර ගැනීම, 2018.01.05 දිනැති 1052/33 අංක දරණ ගැසට් පත්‍රය ප්‍රකාරව සිදු කරනු ලබන බව දන්වා සිටිමි.
එම ගැසට් පත්‍රයට අනුව,

1. රජයේ සැපයීම්වලට ලියාපදිංචියෙන් නිදහස් කිරීමේ අනුමතය සඳහා (අනුමැතිය ලැබීමෙන් පසු)
2. පෞද්ගලික සැපයීම්වලට ලියාපදිංචියෙන් නිදහස් කිරීමට ඉල්ලුම් කිරීම සඳහා (කමිටුව වෙත ඉදිරිපත් කිරීමට පෙර,)
යන පරිදි නැවත නොගෙවන පදනමින් මුදල් අය කරනු ලබන බව දන්වා සිටමි.

මෙයට,

.............................
ප්‍රධාන විධායක නිලධාරී.

To All Importers of Cosmetic Products,

Re: Prior approval for temporary suspended Cosmetic Goods
All importers of Cosmetics Products are hereby informed to that NMRA is unable to issue prior approval for each consignments where goods are registered with NMRA as Cosmetics.Considering the needs in the current economic environment,import control may release following items that carry NMRA licenses and approvals under relevant HS codes of relaxed items.

  • Creams/Lotions/Solutions/Soaps
    Shampoos/Conditioner
    Mouth Washes/Tooth Paste
    Hair Dyes/Colors

Notice

To all representatives of the companies,

Fees for the Application / Approval for Waiver of Registration Letters.

Please be informed that Fees for the Waiver of Registration Letters will be charged as per the internal circular of National Medicines Regulatory Authority dated on 2023.01.25 in according with the Gazette Extraordinary 1052/33 dated 2018.01.05 as follows.

1. Approval for Waive of Registration for the government supplies (After getting approval from the committee)

2. Application for Waiver of Registration for private supplies (Before forwarding to the committee)

(The Fees payable are not refundable)

 

Chief Executive Officer
NMRA.

All importers of Medical Devices are hereby informed to submit Application and additional details for Sample Import License of Medical Devices to Dossier Accepting Point, Medical Devices only on Tuesdays at NMRA Norris Canal Road Office with effective from 01st of January 2023.

Required documents for the Sample Import License Application

  •  Application form for Each product (Form C Schedule IV)
     Business Registration Certificate
     Letter of authorization
     Free Sale Certificate
     ISO 13485 Quality management system certificate ( not mandatory for NMRA approved site)
     Declaration from the manufacturer regarding the confirmation of type and class of the medical device
     Existing Registration Certificate issued by NMRA/FMSA approval by the NMRA
     Product Catalogue/ Brochure
     Sri Lanka Atomic Energy Authority approval for Radiation Emitting Device

Acknowledgement Form for Sample Import License –Medical Devices

 Chief Executive Officer
 NMRA

120, Norris Canal Road, Colombo 10
 011-2687743
 info@nmra.gov.lk