Western Drugs (400)

Required Documentation

  • IECD-01 Application Form (Indent) issued by the Department of Import and Export Control should be duly signed by the importer and affixed with a seal.
  • Where the importer is an organization,
    • Original and a photocopy of the Certificate of Registration of Business (It suffices to submit these documents only at the first instance.)
  • Where the importer is an individual,
    • National Identity Card and its photocopy
  • Proforma Invoice issued by the Exporter or Supplier and it should include the following details:
    • Names and addresses of the exporter and Importer
    • Details of the good or commodity, quantity and value
    • Country of origin
    • Country of shipment
  • Letter of Recommendation or License issued to the Controller General of Import and Export by the Organization with relevant authorization to make recommendation for issuance of a license.

Procedure

  • Submit the above documents required to obtain the license to the counter of the relevant Unit
  • Make payments to the Shroff using the Paying-in-Voucher issued by the counter for approved documents    
  • Submit the receipt issued for the payment to the counter
  • After printing and signing the license, obtain the license from the Counter and its photocopies affixed with the seal confirming the issuance of the license 

License Fees

  • General License Fees – 0.2% of CIF Value
  • Bulk License Fees - 0.2% of CIF Value + Annual Fess Rs. 100,000.00

Recommendation Authority and Customs Classification Code

National Medicines Regulatory Authority

National Medicines Regulatory Authority registers importers separately for each drug and only the relevant importer is authorized to import the particular drug. To facilitate the importation of drugs, National Medicines Regulatory Authority grants registration valid for 5 years and issues import license valid for 1 year. The license contains details such as trade name and generic name of the drug, quantity etc.

Harmonized System Codes
9602.00.10 Worked vegetable or mineral carving material and articles of these materials; moulded or carved articles of wax, of stearin of natural gums or natural resins or of modeling pastes and other moulded or carved articles, not elsewhere specified or included; worked unhardened gelatin (except gelatin of heading 35.03) and articles of unhardened gelatin
2844.40 Radioactive elements and isotopes and compounds other than those of subheading 2844.10, 2844.20 or 2844.30; alloys, dispersions ( including cermets ), ceramic products and mixtures containing these elements; isotopes or compounds; radioactive residues
2908.11 Pentaclorofenol (ISO)
2924.29.90 Other
2925.29 Other
3001.90 Other
3002 Human blood; animal blood prepared for therapeutic, prophylactic or diagnostic uses; antisera and other blood fractions and modified immunological products, whether or not obtained by means of biotechnological processors; vaccines, toxins, cultures of micro-organisms (excluding yeasts) and similar products
3002.10 Antisera and other blood fractions and modified immunological products, whether or not obtained by means of biotechnological processes
3002.20 Vaccines for human medicine
3002.90.10 Saxitoxin ([ (4R)-10,10-dihydroxy-2,6- diiminooctahydro- 1H,8H-pyrrolo [1,2-cl]purin- 4-yl] methyl carbamate)
3002.90.90 Other
3003 Medicaments (excluding goods of heading 30.02, 30.05 or 30.06) consisting of two or more constituents which have been mixed together for therapeutic or prophylactic uses, not put up in measured doses or in forms or packings for retail sale
3003.10 Containing penicillins or derivatives thereof, with a penicillanic acid structure, or streptomycins or their derivatives
3003.31 Containing insulin
3003.39 Other
3003.40 Containing alkaloids or derivatives thereof but not containing hormones or other products of heading 29.37 or antibiotics
3003.90 Other
3004 Medicaments ( excluding goods of heading 30.02 , 30.05 or 30.06 ) consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses ( including those in the form of transdermal administration systems ) or in forms or packings for retail sale
3004.10 Containing penicillins or derivatives thereof, with a penicillanic acid structure, or streptomycins or their derivatives
3004.20 Containing other antibiotics
3004.32 Containing corticosteroid hormones, their derivatives or structural analogues
3004.39 Other
3004.40 Containing alkaloids or derivatives thereof but not containing hormones, other products of heading 29.37 or antibiotics
3004.50 Other medicaments containing vitamins or other products of heading 29.36
3004.90.12 Schedule 02 preparations certified by the Commissioner of Ayurveda
3004.90.20 Antineoplastics and immunosuppressives
3006 Pharmaceutical goods specified in Note 4 to this Chapter
3006.10 Sterile surgical catgut, similar sterile suture materials ( including sterile absorbable surgical or dental yarns) and sterile tissuesterile laminaria and sterile laminaria tents; sterile absorbable surgical or dental haemostatics; sterile surgical or dental adhesion barriers , whether or not labsorbable
3006.20 Blood - grouping reagents
3006.30 Opacifying preparations for X-ray examinations; diagnostic reagents designed to be administered to the patient
3926.90.80 Hardened gelatin capsules
  • The following documents should be submitted in duplicate, together with their originals for debiting the license.
    • Import License, Registration Certificate or Letter of Recommendation from the relevant authority sanctioning the import of goods
    • Import Control License
    • Commercial Invoice endorsed by the Bank
    • Certificates of Analysis
    • Customs Declaration
  • The following matters should be taken into consideration in submitting documents for debiting process.
    • Import License, Registration Certificate or Letter of Recommendation of the relevant authority sanctioning the import should be valid at least until the date of debiting.      
    • Originals of the Certificates of Analysis should be submitted with regard to every drug. Imported drugs should possess a minimum residual shelf life of 75% from the date of debiting, which should be included in the license as a condition. Where the residual shelf life is less than 75%, an additional fee of 10% of CIF Value is charged, in the event that the Controller General of Import and Export grants approval to release the consignment.

Additional Fees

Please refer to the Gazette (Extraordinary) of the Democratic Socialist Republic of Sri Lanka No. 1953/28 dated 11.02.2016 with regard to additional fees.

Veterinary Medicine (410)

Required Documentation

  • Application IECD-01 (Indent) issued by the Department of Import and Export Control- duly filled and signed by the importer with his seal affixed
  • Where the importer is an organization,
    • Original and a photocopy of the Business Registration Certificate (It suffices to submit these documents only at the first instance.)
  • Where the importer is an individual,
    • National Identity Card and its photocopy
  • Proforma Invoice issued by the Exporter or Supplier and it should include the following details :
    • Names and addresses of the exporter and Importer
    • Details of the good or commodity, quantity and value
    • Country of origin
    • Country of shipment
  • Letter of Recommendation or License issued to the Controller General of Import and Export by the Organization with relevant authorization to make recommendation for issuance of a license.

Procedure

  • Submit the above documents required to obtain the license to the counter of the relevant Unit
  • Make payments to the Shroff  using the Paying-in-Voucher issued by the counter for approved documents    
  • Submit the receipt issued for the payment to the counter
  • After printing and signing the license, obtain the license from the Counter and its photocopies affixed with the seal confirming the issuance of the license 

License Fees

  • General License Fees – 0.2% of CIF Value
  • Bulk License Fees - 0.2% of CIF Value + Annual Fess Rs. 100,000.00

Recommendation Authority and Customs Classification Code 

Department of Animal Production and Health

The approval contains details on Proforma Invoice No. and Date, Importer, Supplier, Item No. and Quantity but not the validity period.

Harmonized System Codes
9602.00.10  Worked vegetable or mineral carving material and articles of these materials; moulded or carved articles of wax, of stearin of natural gums or natural resins or of modeling pastes and other moulded or carved articles, not elsewhere specified or included; worked unhardened gelatin (except gelatin of heading 35.03) and articles of unhardened gelatin
2309.90.90 Other
2924.29.90 Other
3001.90 Other
3001.20 Extracts of glands or other organs or of their secretions
3001.90 Other
3002 Human blood; animal blood prepared for therapeutic, prophylactic or diagnostic uses; antisera and other blood fractions and modified immunological products, whether or not obtained by means of biotechnological processes; vaccines ,toxins, cultures of micro-organisms ( excluding yeasts) and similar products
3002.10 Antisera and other blood fractions and modified immunological products, whether or not obtained by means of biotechnological processes
3002.20 Vaccines for human medicine 
3002.30 Vaccines for veterinary medicine 
3002.90 Other 
3002.90.90 Other
3003 Medicaments (excluding goods of heading 30.02, 30.05 or 30.06) consisting of two or more constituents which have been mixed together for therapeutic or prophylactic uses, not put up in measured doses or in forms or packings for retail sale
3003.10 Containing penicillins or derivatives thereof, with a penicillianic acid structure, or streptomycins or their derivatives 
3003.20 Containing other antibiotics
3003.31 Containing insulin 
3003.39 Other
3003.40 Containing alkaloids or derivatives thereof but not containing hormones or other products of heading 29.37 or antibiotics
3003.90 Other 
3004 Medicaments ( excluding goods of heading 30.02 , 30.05 or 30.06 ) consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses ( including those in the form of trans dermal administration systems ) or in forms or packings for retail sale
3004.10 Containing penicillins or derivatives thereof, with a penicillanic acid structure, or streptomycins or their derivatives
3004.20 Containing other antibiotics
3004.31 Containing insulin
3004.39  Other
3004.40 Containing alkaloids or derivatives thereof but not containing hormones, other products of heading 29.37 or antibiotics
3004.50 Other medicaments containing vitamins or other products of heading 29.36
3004.90 Other
3004.90.20 Antineoplastics and immunosuppressives
3004.90.90 Other 
3006 Pharmaceutical goods specified in Note 4 to this Chapter
3006.10 Sterile surgical catgut, similar sterile suture materials (including sterile absorbable surgical or dental yarns) and sterile tissue sterile laminaria and sterile laminaria tents; sterile absorbable surgical or dental haemostatics; sterile surgical or dentaadhesion barriers , whether or not labsorbable
3006.20 Blood - grouping reagents
3006.30 Opacifying preparations for X-ray examinations; diagnostic reagents designed to be administered to the patient
3926.90.80 Hardened gelatin capsules
  • The following documents should be submitted in duplicate, together with their originals for debiting the license.
    • Import License, Registration Certificate or Letter of Recommendation of the relevant authority sanctioning the import of goods
    • Import Control License
    • Commercial Invoice endorsed by the Bank
    • Certificates of Analysis
    • Customs Declaration
  • The following matters should be taken into consideration in submitting documents for debiting process.
    • Import License, Registration Certificate or Letter of Recommendation of the relevant authority sanctioning the import should be valid at least until the date of debiting.      
    • Originals of the Certificates of Analysis should be submitted with regard to every drug. Imported drugs should possess a minimum residual shelf life of 75% from the date of debiting, which should be included in the license as a condition. Where the residual shelf life is less than 75%, an additional fee of 10% of CIF Value is charged, in the event that the Controller General of Import and Export grants approval to release the consignment.

Additional Fees

Please refer to the Gazette (Extraordinary) of the Democratic Socialist Republic of Sri Lanka No. 1953/28 dated 11.02.2016 with regard to additional fees.

 Ayurvedic Drugs (420)

Required Documentation

  • IECD-01 Application Form (Indent) issued by the Department of Import and Export Control should be duly signed by the importer and affixed with a seal
  • Where the importer is an organization,
    • Original and a photocopy of the Certificate of Registration of Business (It suffices to submit these documents only at the first instance.)
  • Where the importer is an individual,
    • National Identity Card and its photocopy
  • Proforma Invoice issued by the Exporter or Supplier and it should include the following details :
    • Names and addresses of the exporter and Importer
    • Details of the good or commodity, quantity and value
    • Country of origin
    • Country of shipment
  • Letter of Recommendation or License issued to the Controller General of Import and Export by the Organization with relevant authorization to make recommendation for issuance of a license. 

Procedure

  • Submit the above documents required to obtain the license to the counter of the relevant Unit
  • Make payments to the Shroff  using the Paying-in-Voucher issued by the counter for approved documents    
  • Submit the receipt issued for the payment to the counter (After printing and signing the license, obtain the license from the Counter and its photocopies affixed with the seal confirming the issuance of the license)

License Fees

  • General License Fees – 0.2% of CIF Value
  • Bulk License Fees - 0.2% of CIF Value + Annual Fess Rs. 100,000.00

Recommendation Authority and Customs Classification Code

Department of Ayurveda -

Approval given for the import of commercial consignments includes name of the drug, its registration number, name and address of the manufacturer but does not include the quantity. It is valid for 3 years.    
In importation of samples for registration, these samples carry the generic name, manufacturer’s name and address but not the validity period.

Harmonized System Codes
3002.10 Antisera and other blood fractions and modified immunological products, whether or not obtained by means of biotechnological processes
3002.90.90 Other
3003.90.90 Other
3004 Medicaments (excluding goods of heading 30.02, 30.05 or 30.06) consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses (including those in the form of transdermal administration systems) or in forms or packings for retail sale.
3004.90.12 Schedule 02 preparations certified by the Commissioner of Ayurveda
3004.90.90 Other
3006 Pharmaceutical goods specified in Note 4 to this Chapter
3926.90.80 Hardened gelatin capsules
  • The following documents should be submitted in duplicate, together with their originals for debiting the license.
    • Import License, Registration Certificate or Letter of Recommendation from the relevant authority sanctioning the import of goods
    • Import Control License
    • Commercial Invoice endorsed by the Bank
    • Certificates of Analysis
    • Customs Declaration
  • The following matters should be taken into consideration in submitting documents for debiting process.
    • Import License, Registration Certificate or Letter of Recommendation of the relevant authority sanctioning the import should be valid at least until the date of debiting.      
    • Originals of the Certificates of Analysis should be submitted with regard to every drug. Imported drugs should possess a minimum residual shelf life of 75% from the date of debiting, which should be included in the license as a condition. Where the residual shelf life is less than 75%, an additional fee of 10% of CIF Value is charged, in the event that the Controller General of Import and Export grants approval to release the consignment.

Additional Fees

Please refer to the Gazette (Extraordinary) of the Democratic Socialist Republic of Sri Lanka No. 1953/28 dated 11.02.2016 with regard to additional fees.

Homoeopathic Drugs (430)

Required Documentation

  • IECD-01 Application Form (Indent) issued by the Department of Import and Export Control should be duly signed by the importer and affixed with a seal
  • Where the importer is an organization,
    • Original and a photocopy of the Certificate of Registration of Business (It suffices to submit these documents only at the first instance.)
  • Where the importer is an individual,
    • National Identity Card and its photocopy
  • Proforma Invoice issued by the Exporter or Supplier and it should include the following details :
    • Names and addresses of the exporter and Importer
    • Details of the good or commodity, quantity and value
    • Country of origin
    • Country of shipment
  • Letter of Recommendation or License issued to the Controller General of Import and Export by the Organization with relevant authorization to make recommendation for issuance of a license.

Procedure

  • Submit the above documents required to obtain the license to the counter of the relevant Unit
  • Make payments to the Shroff  using the Paying-in-Voucher issued by the counter for approved documents    
  • Submit the receipt issued for the payment to the counter

License Fees

  • General License Fees – 0.2% of CIF Value
  • Bulk License Fees - 0.2% of CIF Value + Annual Fess Rs. 100,000.00

Recommendation Authority and Customs Classification Code

Homeopathic Medical Council-

Approval is granted only with the seal affixed on the value of the Pro forma Invoice.

Harmonized System Codes
9602.00.10 Capsules used in the manufacture of pharmaceutical products
3004.90.90 Other

The following documents should be submitted in duplicate, together with their originals for debiting the license.

  • Import License, Registration Certificate or Letter of Recommendation from the relevant authority sanctioning the import of goods
  • Import Control License
  • Commercial Invoice endorsed by the Bank
  • Certificates of Analysis
  • Customs Declaration

The following matters should be taken into consideration in submitting documents for debiting process.

  • Import License, Registration Certificate or Letter of Recommendation of the relevant authority sanctioning the import should be valid at least until the date of debiting.      
  • Originals of the Certificates of Analysis should be submitted with regard to every drug. Imported drugs should possess a minimum residual shelf life of 75% from the date of debiting, which should be included in the license as a condition. Where the residual shelf life is less than 75%, an additional fee of 10% of CIF Value is charged, in the event that the Controller General of Import and Export grants approval to release the consignment.

Additional Fees

Please refer to the Gazette (Extraordinary) of the Democratic Socialist Republic of Sri Lanka No. 1953/28 dated 11.02.2016 with regard to additional fees.

Surgical Equipment (450)

Required Documentation

  • IECD-01 Application Form (Indent) issued by the Department of Import and Export Control should be duly signed by the importer and affixed with a seal.
  • Where the importer is an organization,
    • Original and a photocopy of the Certificate of Registration of Business (It suffices to submit these documents at the first instance.)
  • Where the importer is an individual,
    • National Identity Card and its photocopy
  • Proforma Invoice issued by the Exporter or Supplier and it should include the following details :
    • Names and addresses of the exporter and Importer
    • Details of the good or commodity, quantity and value
    • Country of origin
    • Country of shipment
  • Letter of Recommendation or License issued to the Controller General of Import and Export by the Organization with relevant authorization to make recommendation for issuance of a license. 

Procedure

  • Submit the above documents required to obtain the license to the counter of the relevant Unit
  • Make payments to the Shroff  using the Paying-in-Voucher issued by the counter for approved documents    
  • Submit the receipt issued for the payment to the counter (After printing and signing the license, obtain the license from the Counter and its photocopies affixed with the seal confirming the issuance of the license)  

License Fees

  • General License Fees – 0.2% of CIF Value
  • Block License Fees - 0.2% of CIF Value + Annual Fess Rs. 100,000.00

Recommendation Authority and Customs Classification Code

National Drug Regulatory Authority

National Drug Regulatory Authority registers importers separately for each drug and only the respective importer is authorized to import the particular drug. To facilitate the importation of drugs, National Drug Regulatory Authority grants registration valid for 5 years and issues import license valid for 1 year. The license contains details such as trade name and generic name of the drug, quantity etc.

Harmonized System Codes
3002.10 Antisera and other blood fractions and modified immunological products, whether or not obtained by means of biotechnological processes
3006.10 Sterile surgical catgut, similar sterile suture materials ( including sterile absorbable surgical or dental yarns) and sterile tissuesterile laminaria and sterile laminaria tents; sterile absorbable surgical or dental haemostatics; sterile surgical or dental adhesion barriers , whether or not labsorbable
3006.20 Blood - grouping reagents
3006.30 Opacifying preparations for X-ray examinations; diagnostic reagents designed to be administered to the patient
  • The following documents should be submitted in duplicate, together with their originals for debiting the license.
    • Import License, Registration Certificate or Letter of Recommendation from the relevant authority sanctioning the import of goods
    • Import Control License
    • Commercial Invoice endorsed by the Bank
    • Certificates of Analysis
    • Customs Declaration
  • The following matters should be taken into consideration in submitting documents for debiting process.
    • Import License, Registration Certificate or Letter of Recommendation of the relevant authority sanctioning the import should be valid at least until the date of debiting.      
    • Originals of the Certificates of Analysis should be submitted with regard to every drug. Imported drugs should possess a minimum residual shelf life of 75% from the date of debiting, which should be included in the license as a condition. Where the residual shelf life is less than 75%, an additional fee of 10% of CIF Value is charged, in the event that the Controller General of Import and Export grants approval to release the consignment.

Additional Fees

Please refer to the Gazette (Extraordinary) of the Democratic Socialist Republic of Sri Lanka No. 1953/28 dated 11.02.2016 with regard to additional fees.