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Pharmaceutical Expertise

  • End-to-end Pharmaceutical Product Registration
  • Authorized Local Representation
  • NMRA Manufacturing Site Registration
  • Sample Import License Support
  • Query Support Management till Approval
  • Pharmaceutical Lifecycle Management Support
  • Ad-hoc Regulatory Affairs Consultation
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Overview of the Sri Lankan
Regulatory Landscape

National Medicines Regulatory Authority (NMRA) is the drug Regulatory Authority under Health Ministry in Sri Lanka. NMRA mainly regulates and evaluates the medicinal products/drugs, devices, cosmetics, and the manufacturing facilities with or without site visits. NMRA issues wholesale licenses, retail licenses and transport licenses for medicinal products/drugs and devices. NMRA along with the Consumer Affairs controls the pricing for selected drugs and devices in Sri Lanka. Under NMRA there is a sub-department to approve labeling and advertising.

The Medicines Evaluation Committee (MEC), formed under the NMRA Act, carries out scientific and technical reviews, inspections and surveillance activities of the medicines forwarded for registration, to ensure quality, efficacy, safety, and cost of such medicines, as per the registration and certification procedures.

 

Industries We Serve

NMRA is the key drug Regulatory Agency in Sri Lanka. The NMRA ACT, No. 5 of 2015 provides the authority to the NMRA to regulate and control the manufacturing, importation, storage, distribution, transportation, pricing, wholesale and retail sale, advertising and disposal of medicines.

  • End-to-end registration support
  • Authorized Local agent support
  • Manufacturing site approval support
  • Sample import license support
  • Compilation and Submission of the dossier to the NMRA
  • Query support management till approval
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NMRA, under the Ministry of Health (MoH) is responsible for regulation and control of registration, Licencing, manufacturing, importation, and other aspects pertaining to medical devices in Sri Lanka.

  • End-to-end Medical Device Registration
  • Medical Device Compliance in Sri Lanka
  • Authorized Local Agent
  • Manufacturing Site Registration
  • Application submission to the NMRA
  • Query support management till approval
  • Translation Services
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Food supplements/dietary supplements fall under the borderline category, as they have combined characteristics of foods along with medicine. According to the National Medicines Regulatory Authority (NMRA) Act No. 05 of 2015, the NMRA Sri Lanka is responsible for the regulation and control of registration, licensing, manufacture, importation, and all other Regulatory aspects pertaining to borderline products.

  • Preliminary Evaluation (Product Classification)
  • Formula Review/Ingredients Assessment
  • Food Label Review and Claims Review
  • NMRA Product Registration
  • Interaction with the FCA and NMRA Sri Lanka
  • Legal Representation Services
  • Regulatory Support Report
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The cosmetic products industry in Sri Lanka has recorded a gradual growth in the past few years, with an eventual increase in the supply of these products in the market. With the rise in per capita income, urbanization, and use of internet, consumers have become much more informed about their skin types, and thus, are moving towards international trends, which has resulted in an increased demand of locally made private label cosmetics and imported cosmetics in Sri Lanka.

  • Cosmetics Classification as per the NMRA Cosmetics Guidelines
  • Cosmetic Formulation Review/ Cosmetics Ingredient Review
  • Cosmetic Registrations application with the National Medicines Regulatory Authority (NMRA)
    • Provisional Registration
    • Full Registration
  • Cosmetics Legal Representation and Importation Services
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About Freyr

Freyr is a leading, niche, full-service global Regulatory Solutions and Services Company supporting, Large, Medium and Small size global Life sciences companies, (Pharmaceutical | Generics | Medical Device | Biotechnology | Biosimilar | Consumer Healthcare | Cosmetics | Chemicals) in their entire Regulatory value-chain; ranging from Regulatory Strategy, Support, Dossiers, Submissions etc. to Post- Approval / Legacy Product Maintenance, Labeling, Artwork Change Management and other related functions.

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Our Regional Expertise

Being a Globally Local firm, we have our presence in the following countries, click to know more

Location

No. 724, 7th Floor, Janajaya City, Rajagiriya, Colombo, Sri Lanka

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