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 |
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.
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 |
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.
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 |
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.
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.
The following matters should be taken into consideration in submitting documents for debiting process.
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.
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 |
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.
No: 75 1/3, 1st Floor, Hemas Building,
York Street,
P.O. Box - 559,
Colombo 01,
Sri Lanka.
(94) 112 326 774
(94) 112 322 046
(94) 112 322 053
(94) 112 322 007
(94) 112 328 486
deptimpt[at]sltnet.lk