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Borderline Products

Definition-Borderline Product according to the NMRA Act of 2015

 

“Borderline products” means the products having combined characteristics of medicines and foods, medicines and medical devices or medicines and cosmetics and in deciding whether a product is a borderline product the following shall be taken into consideration: -

 

(a) the intended use of the product (or its primary function) and its mode of action;

 

(b) the therapeutic claims that the manufacturer makes about the product (claims to treat or prevent disease or to   interfere with the normal operation of a physiological function of the human body) ;

 

(c) the pharmacological active substance(s), if any, used in the product;

 

(d) the concentration of the active substances;

 

(e) the level of efficacy of the active substance of the product; and

 

(f) the ingredients used and the concentrations at which they are used.

Page 90 & 91-NMRA Act

 

Definition - Nutraceutical

“Nutraceutical” means a product isolated or purified from food which is generally sold in medicinal form not usually

associated with food and provide physiological benefit or protection against chronic disease;

 

Page 95 –NMRA Act

 

Borderline Products Submission Instructions

1. Documents required for Classification of Borderline Products

  1. Covering letter
  2. Letter of authorization from manufacturer
  3. Master formula (If master formula is available, weights should be calculated per elements for each ingredients)
  4. Summarized product description
  5. Packaging materials (Original/Art work)
  6. Two samples if available

2. Documents required for Sample Import License

  1. Covering letter
  2. Schedule V form
  3. Copy of E-mail by the BPEC (Borderline Products Evaluation Committee)
  4. Required quantity of samples with description

3. Documents required for Registration of Borderline Products

  1. Comprehensive table of content (Index).
  2. Page numbering in both ways
  3. Acknowledgement Form
  4. Letter of Authorization from manufacturer
  5. Master Formula (If master formula is available, weights should be calculated per elements for each ingredients)
  6. Completed & signed borderline products submission form
  7. Borderline products evaluation check list (un filled)
  8. Relevant documents according to the submission form
  9. Two soft copies in two separate CDs with covers (Cover size: 5.5’ ×5’)
  10. Two samples

Borderline Product Submission Form

1.Name of the Borderline substance

 

 

 

Brand Name

 

 

Registration status:

(Please “√”)

New

RR

 

Status of the applicant

(Please “√”)

Manufacturer

Importer

 

Route of administration:

 

Dosage form

(If applicable only)

 

Type of product:

(Please “√”)

Medicine and

Food

Medicine and Medical Device

Medicine and Cosmetic

 

2. Details of the Marketing Authorization holder (Applicant) in Sri Lanka

 

Name of the applicant

 

 

 

Address of the applicant

 

 

 

Telephone no.

 

 

Email / web

 

 

Note: Overseas manufacturers should forward their application only through a local agent in Sri Lanka

 

 

3. Details of the Manufacturer ( Please “√” where needed)

 

Name

 

 

 

Actual manufacturer

Contract manufacturer

 

Other

 

Address of the Actual Manufacturing  Site

 

Any other address

 

 

Product is registered and marketed in the country of manufacture

Registered

Marketed

 

Classification in country of manufacture

 

Borderline substance

 

 

Medical Device

 

 

Health supplement

 

 

Listed product

 

 

Cosmetic Product

 

 

Traditional Medicines

 

 

Other

 

 

If it is a Device

 

Does this product require dedicated instrumentation?

If Yes

Details

 

 

Availability of User Manual

Yes

No

Justification for not submitting

 

 

 

 

4. Please provide documents, if registered or marketed in the following countries

Country

Product Classification

  1. Australia

 

  1. Canada

 

  1. European Union (EU)

 

  1. Japan

 

  1. New Zealand

 

  1. Singapore

 

  1. UK

 

  1. USA

 

  1. Malaysia

 

  1. Thailand

 

  1. India

 

Justification for not submitting

 

 

 

 

 

 

5. Please provide the following information on finished  product

 

5.1 Certificate of Pharmaceutical Product (COPP)

 

5.2 Certificate of Free Sale (CFS) (Applicable if COPP is not available)

 

5.3 Certificate of Good Manufacturing Practice (GMP) / ISO Certificate

 

Justification for not submitting

 

 

5.4      Master formula

5.4.1    Manufacturing formula with batch size

5.4.2    Validated testing procedures for finished product

5.4.3    Validation report

5.4.4    Manufacturing process or Flow diagram

Justification for not submitting

 

 

 

 


5.5  Please provide the Certificate of Analysis (COA) and Stability Report for finished product if

applicable

Please “√” the following details accordingly

Appearance

 

Chemical Assay for active ingredients

 

Limits for heavy metals

 

Limits for microbial contamination

 

Disintegration test

 

Any other specific test

 

*Complete real time stability data should be submitted at least for two commercial batches after 2 years of the product registration. Failure on submission will cause the product to be suspended until the complete documents are submitted; the registration of the product will be terminated if the complete documents still cannot be produced upon renewal of product registration.

Justification for not submitting

 

 

 

 

6. Please provide efficacy data if available

 

Published reports

Detail Clinical trial report for the product if available

 

7 .Composition per dosage form

 

Each Tablet/ Capsule/ 5ml/……………….…….)  contains:

 

Name of the ingredient

Botanical name (if available)

Amount

Function

Unit: g/IU, etc

i.

 

 

 

ii.

 

 

 

iii.

 

 

 

iv.

 

 

 

v.

 

 

 

vi.

 

 

 

vii.

 

 

 

viii.

 

 

 

ix.

 

 

 

x.

 

 

 

xi.

 

 

 

xii.

 

 

 

xiii.

 

 

 

xiv.

 

 

 

xv.

 

 

 

xvi.

 

 

 

xvii.

 

 

 

xviii.

 

 

 

xix.

 

 

 

xx.

 

 

 

xxi.

 

 

 

xxii.

 

 

 

xxiii.

 

 

 

xxiv.

 

 

 

xxv.

 

 

 

Justification for not submitting

 

 

 

 

8 .Instrument with standard accessories and spare parts (If applicable)

Name of the accessory / spare part

Catalogue number

Function

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Justification for not submitting:

 

 

 

9.Please provide the following documents

9.1 PIL

9.2 Packaging materials (primary and secondary) / Art work

9.3 Promotional materials

Justification for not submitting

 

 

 

Declaration

 

I’m responsible for the safety, quality & effectiveness of the product and any possible hazardous effects caused by the use of this borderline product.

I declare that the particulars given in this application (page1-4) are true and that the supporting documents enclosed are authentic or true copies.

Signature:……………………………

Name:……………………………….

Designation:…………………………

Date:…………………………………

 

 

3. Details of the Manufacturer ( Please “√” where needed)

Name

Actual manufacturer

Contract manufacturer

Other

Address of the Actual Manufacturing  Site

Any other address

Product is registered and marketed in the country of manufacture

Registered

Marketed

Classification in country of manufacture

Borderline substance

Medical Device

Health supplement

Listed product

Cosmetic Product

Traditional Medicines

Other

If it is a Device

Does this product require dedicated instrumentation?

If Yes

Details

Availability of User Manual

Yes

No

Justification for not submitting