NMRA

Regulatory Overview

Definition for cosmetics:“Cosmetic” means any natural or synthetic substance or preparation intended to be used, or capable or purported or claimed to be capable of being used, on the various external parts of the human body (including epidermis, hair system,nails, lips and external genital organs) or the teeth and the mucous membranes of the oral cavity for the exclusive or main purpose of cleaning, perfuming or protecting them, or of keeping them in good condition, or of changing or modifying their appearance, or correcting body odors”.

Cosmetic Evaluation Sub Committee (CESC)

The Cosmetic Evaluation Sub Committee (CESC) will carry out the technical evaluation of products submitted for registration and assist the Authority to regulate and control all aspects pertaining to cosmetics.
The CESC meeting held once a month usually in every 4^th Friday.

How to register your product

Cosmetic dossier acceptance day is every Wednesday of the week from 9.00am to 3.30pm.

‍OBJECTIVE OF REGISTRATION

To ensure that cosmetic products in Sri Lanka are safe and not injurious and harm to health.
To prohibit the use of certain toxic substances as ingredients in cosmetic products.
To ensure that cosmetic products are properly labelled with batch markings and listing of ingredients used.
To protect from whitening products.

Cosmetic product registration can be categorized as,

· Locally manufactured cosmetic product registration

First step: Obtaining the acknowledgement from the manufacturing regulatory division of NMRA.
Second step: Obtaining the ISO22716:2007 certificate for the cosmetic manufacturing site from a SLAB accredited inspection body.
Third Step: Apply for product registration.

· Imported cosmetic product registration

First step: Obtaining the sample import license.
Second step: Apply for product registration.

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‍How to register your product

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1 .For Imported cosmetics

A. Documents for Obtaining Sample Import License

Fulfilled application form [12 KB]
Business Registration Certificate
Original Letter of authorization issued by the product (Brand) owner within a three year period,clearly indicating the product/Brand owner, product with brand name,manufacturer, and the local authorized agent in Sri Lanka. (as a Sole Agent LOA or Tabulated LOA)
Declaration from the manufacturer stated no more Importers registered in Sri Lanka.
Filled and signed declaration form.
Master formula/ Composition: the ingredient list by their chemical name(INCI) with CAS number, function and include their exact quantities (w/w%), as per the EU cosing data base.(The composition will be assessed at the dossier evaluation stage. At this stage, only the percentage of ingredients such as glycolic acid, salicylic acid and urea will be considered)
Product label (Art work/Scanned commercial label)

B. Data Requirement for Preparation of Cosmetic Application for Registration

1. For Imported cosmetics

Fulfilled “Schedule I form A & B” application [75 KB]
Copy of sample import license.
Valid and original free sale certificate or certificate issued by the cosmetic regulatory body/chamber of commerce (It should be attested by the Sri Lankan embassy in the respective country).
Original Letter of authorization issued by the product (Brand) owner within a three year period, clearly indicating the product/Brand owner, product with brand name, manufacturer, and the local authorized agent in Sri Lanka.
Copy of business registration certificate.
Certificate of analysis report for finished product with specifications and results.
Master formula/ Composition: the ingredient list by their chemical name (INCI) with CAS number, function and include their exact quantities (w/w%), as per the EU cosing data base.
Declaration confirming the finished product is free from steroids issued by the manufacturer (for leave-on skin care products).
Original art work of the product labels.
Cosmetic product safety report for the finished product signed by a qualified person.
Valid ISO 22716:2007 Certification/ GMP Certificate issued by the cosmetic regulatory body of the country of origin for the cosmetic manufacturing plant.
Fully packed samples (two) of cosmetics in the form that is intended to be marketed(including Lot no., Manufacturing Date,Expiry date, Manufacturer’s & Importers details)
- Documents should be in English, in a legible font size, printed in one side A4 and submitted in a hard file cover, and all pages should be numbered from top to bottom and vice versa with an index.
- Separate applications should be made in respect of each cosmetic to be registered. [i.e.different brands etc.]. Products of foreign manufacturers should be submitted through a Marketing authorization Holder.
- Up to ten (10) colour variant within the same cosmetic product series can be submitted under a single application file. This applies to cosmetic products such as: Nail Polish, Hair Dye, Hair colour, Lipstick, Lip liner, Eye Shadow, Eye Liner, Eye pencil, Mascara, Concealer, Colour corrector, Contour, Foundation, Face Powder
  - Please note: For this type of submission,the formula, packaging, product features, and all other parameters must be identical, except for the colour of the cosmetic product. Applicants must submit the formula, label, and test reports for all ten colour variants as part of the single file. The applicable fee for this single file submission will be equivalent to the total fee for ten separate files, as previously charged.

2. For Locally manufactured cosmetics

First step: Obtain the acknowledgment letter from the Manufacturing Division of the NMRA by visiting on Thursday. This letter is required for the ISO 22716 inspection of your manufacturing site to be conducted by a SLAB-accredited ISO inspection body.

Once got the ISO22716:2007 Certification for the facility can proceed with the product registration.

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Fulfilled “Schedule 1 form A & C” application
Copy of business registration certificate.
Certificate of analysis report for finished product with specifications and results issued by SLAB accredited laboratory or as per the SLSI standards Note: Heavy metal test results (for Pb, Hg, As, Cd) are mandatory for the skin care products.
Master formula/ Composition: the ingredient list by their chemical name (INCI) with CAS number, function and include their exact quantities (w/w%), as per the EU cosing data base.
Declaration confirming the finished product is free from steroids issued by the manufacturer (for leave-on skincare products).
Original art work of the product label.(Label should be in three languages including Sinhala, Tamil and English)
Material safety data for each raw material
Valid ISO 22716:2007 Certification/ GMP Certificate issued by the cosmetic regulatory body of the country of origin for the cosmetic manufacturing plant.
Fully packed samples (two) of cosmetics in the form that is intended to be marketed (including Lot no.,Manufacturing Date, Expiry date,Manufacturer’s details)
- Documents should be in English, in a legible font size, printed in one side A4 and submitted in a hard file cover, and all pages should be numbered from top to bottom and vice versa with an index.
- Separate applications should be made in respect of each cosmetic to be registered. [i.e,different brands etc.]. Product owner should submit the files to NMRA.
- Up to ten (10) colour variant within the same cosmetic product series can be submitted under a single application file. This applies to cosmetic products such as: Nail Polish, Hair Dye, Hair colour, Lipstick, Lip liner, Eye Shadow,Eye Liner, Eye pencil, Mascara, Concealer, Colour corrector, Contour,Foundation, Face Powder
  - Please note: For this type of submission,the formula, packaging, product features, and all other parameters must be identical, except for the colour of the cosmetic product. Applicants must submit the formula, label, and test reports for all ten colour variants as part of the single file. The applicable fee for this single file submission will be equivalent to the total fee for ten separate files, as previously charged.

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Supportive documents for product label claims (For both local and imported products)

Product dossier should contain all supportive scientific evidence/clinical studies for label claims.

Claims such as ‘dermatologically tested for skin irritancy and allergy’, ‘ophthalmologically tested’, ‘revitalize’, ‘rejuvenate’, and SPF value are not limited to those claims listed above.

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Validity Period of Registration

The Provisional Registration for a period of two year (or one) will be issued for first time registration and is specified in the certificate.
The Full Registration of a product is valid for a period of five years and is specified in the certificate.
When additional data are requested, the applicant will have to furnish additional information requested by the authority within 3 months to facilitate further evaluation.
If the product is rejected, the market authorization holder will be able to appeal for registration within a one month. If not it will not be considered.

Applicable timelines for cosmetic dossier evaluation are as follows:

Sample import license - 30working days
New file evaluation – 90working days
Additional file evaluation –60 working days

If the dossier undergoes external evaluation, the applicable evaluation timeline may be extended accordingly.

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Renewal of Registration

Application for renewal should be made before six months from the date of expiry of registration.

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Flow Chart of Registration Process of Cosmetic is as Follows

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Steps involved for registration of cosmetic

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Approval of Manufacturing sites

‍For locally manufactured cosmetics:

First step: Obtaining the ISO 22716:2007certificate for the cosmetic manufacturing facility is compulsory for all local manufacturers.

Prior to obtain the ISO 22716:2007 certification, local manufacturer need to obtain the acknowledgment letter from the Manufacturing Regulatory Division of NMRA by visiting on Thursday(Contact Manufacturing Regulatory Division for further information). This acknowledgement letter is required for the ISO 22716:2007 inspection of your manufacturing site to be conducted by a SLAB-accredited ISO inspection body.

Once got the ISO22716:2007 certification for the manufacturing facility can proceed with the product registration.

For imported cosmetics:

A valid ISO 22716:2007 certificate for the cosmetic manufacturing facility, or a valid GMP certificate issued by the regulatory authority of the country of origin of the product, should be submitted.

Licensing of Local Manufacturing facilities

The process applies for local manufacturing sites who intended to get marketing authorization for their products in Sri Lanka. The procedure includes a desk review of essential documents including the site master file and several GMP Inspections.

A local manufacturer who wants to register products in Sri Lanka needs to furnish applications regarding his manufacturing facilities. A separate application needs to be submitted to each manufacturing site.

Application has to be submitted online via NMRA’s web portal eNMRA which requires uploading of essential information and documents to enable a desk review and GMP Inspections.

The NMRA Act, No. 5 of 2015 (section 51) & regulations 26 to 30 of part II of medicines regulations pronounce the legal requirements.

After these procedures, an approved Local manufacturer can submit application for formulation approvals.

After obtaining the formulation approval and GMP approval for commercial manufacturing of the facility, local manufacturer can apply for the product registration. After that, local manufacturer can apply for the manufacturing license.

Stages for beginners;

Local manufacturer’s profile creation
Approval of the proposed layout of the manufacturing plant
Initial land inspection (optional)
Approval for the formulations
Initial building inspection -during the construction (Optional)Inspection of the plant before installing the manufacturing equipment and machineries after completion of construction of the building
Application to request inspection of the plant after completion of the installment of manufacturing equipment and machineries including necessary qualifications (Complete SMF)
Approval of the manufacturing facility (Licensing of manufacturing site)
Inspection of the plant to get approval for commercial batch manufacturing (GMP Inspection)
Application for GMP certificate (Optional)
Application for product registration
Application to get manufacturing licenses for individual products
Application to get COPP/FSC (Optional)

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Site Master Files

Site Master Files are submissions to NMRA used to provide confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of Medicines, Medical Devices, Borderline products and cosmetics.

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‍Guidance for Site master Files

References:

WHO guideline for drafting a site master file, Annex 14, WHO TRS No. 961, 2011
Explanatory notes for pharmaceutical manufacturers on the preparation of a site master file; PE 008 – 4, 1 January 2011, Pharmaceutical Inspection Co-operation Scheme (PIC/S)

Good Manufacturing Practices (GMP)

Good manufacturing practice (GMP) is that part of quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorization.

The National Medicines Regulatory Authority Act No. 5 of 2015 interprets GMP guidelines as ‘good manufacturing guidelines issued by the World Health Organization’. As such, the National Medicines Regulatory Authority (NMRA) adopts the WHO GMP guidelines along with its subsequent updates for the purpose of regulation of pharmaceutical manufacture. The manufacturers are expected to adhere to the Good Manufacturing Practices throughout their activities.

Pharmaceutical manufacturers who intend to apply for marketing authorization in Sri Lanka may be subjected to one or several GMP inspections prior to their site approvals.

GMP Guidelines available on WHO website:

https://www.who.int/teams/health-product-and-policy-standards/standards-and-specifications/norms-and-standards-for-pharmaceuticals/guidelines/production

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WHO good manufacturing practices for pharmaceutical products: main principles:

https://www.who.int/medicines/areas/quality_safety/quality_assurance/TRS986annex2.pdf?ua=1

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WHO good manufacturing practices for sterile pharmaceutical products:

https://www.who.int/docs/default-source/medicines/norms-and-standards/guidelines/production/trs961-annex6-gmp-sterile-pharmaceutical-products.pdf?sfvrsn=61682f0c_0

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WHO good manufacturing practices for biological products:

https://www.who.int/publications/m/item/annex-2-WHO-gmp-for-biological-products.

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Guidelines

Guideline on Approval of an Overseas Manufacturing Plant of Medicines

Guideline on Preparation of Site Master Files

Guideline for preparation and conduct of the GMP inspection

Advertisements & Promotions

The Advertising Committee of the NMRA regulates advertisements - printed and electronic material - related to medicines, devices, borderline products and cosmetics to ensure such advertisements are ethical, accurate and appropriate.

Working definition & general rules

Advertisement includes any representation by any means whatsoever, for the purpose of promoting directly or indirectly the manufacture, sale or disposal of any medicine medical device, borderline product or cosmetic.

Any person who wishes to advertise or promote a medicine, medical device, borderline product and cosmetic should get prior written approval of the Authority to do so.
Medicines, medical devices, borderline products and cosmetic should not be advertised or promoted to the general public for the treatment, prevention or cure of any of the prescribed diseases, disorders or abnormal physical states.

Our Scope & Responsibility

Provide standards and general requirements that must be adhered to when producing commercials, infomercials and public service announcements, which are relevant to medicines, medical devices, borderline products and cosmetics.
Scrutinize each advertisement and ensure it complies with the advertisement guidelines that are published in the NMRA website before granting approval or rejecting an application.
Provide assistance to applicants regarding general interpretation of advertising guidelines related to medicines, medical devices, borderline products and cosmetics prior to advertise.
Copies of the advertisement
If submitted as print copies - 8 copies (e.g. newspaper ads, TV/radio commercial scripts)
For TV/radio commercials - 3 CD-ROMs
Applicants should consider the following when designing an advertisement:
Active Ingredient/s should be prominently mentioned. (Generic Name)
In the event of medicines, warning about over dosage
Any special warnings
Price of the product
Application for Advertising of Medicines, Medical devices, Borderline products and Cosmetics [ 111 KB ]

Application form

Application for Sample License of Cosmetics for Test/Registration
‍Schedule I form A & B
Declaration of the Authorized person
Processing sheet for cosmetic applications
Checklist for submitting documents - New Applications (This updated checklist will be effective from 03rd December 2025)
Checklist for Submitting Documents – Sample Import License

Guidance documents

Guidelines for registration of cosmetics in Sri Lanka

Cosmetic Evaluation Subcommittee Decisions

Decision on Ingredients for Cosmetic Products

Products contain more than 4% of glycolic acid will not be registered under cosmetic category.
Limitations of Salicylic acid for cosmetic products
- For purposes other than inhibiting the development of micro-organisms in the product / preservative :
  - Rinse -Off hair products - (a) 3.0%
  - Other products except body lotion, eye shadow, mascara, eyeliner, lipstick, roll-on deodorant / non-spray deodorant - (b) 2.0%
  - Body lotion, eye shadow, mascara, eyeliner, lipstick, roll-on deodorant / non-spray deodorant & oral products - (c) 0.5%
  - (a) (b) (c) Not to be issued in preparations for children under 3 years of age. Not to be used in applications that may lead to exposure of the end-user's lungs by inhalation.
- As a preservative :
  - Salicylic acid: 0.5%
  - Salicylic acid salts: 0.5 %(acid)
  - Salicylic acid: Not to be used in products for children under 3 years of age. Not to be used in applications that may lead to exposure of the end-user's lungs by inhalation.
  - Salicylic acid salts: Not to be used in products for children under 3 years of age, except for shampoos.
Products contain more than 5% of Urea acid will not be registered under cosmetic category.

Products containing glutathione in concentrations below 2% (w/w) are permitted to be registered as cosmetics. However, claims such as “Contains glutathione” and“ whitening” or any similar meanings are not permitted. Further, if precursors of glutathione are present in the product, decisions regarding those products will be made on a case-by-case basis.

Fees

NMRA Monthly fee for Cosmetic - Effective from 01/07/2025

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Registered cosmetics products

Valid Cosmetic Product List - 10.06.2026

Cosmetics