| Name | Requirement to register drugs and medical products before importation |
|---|---|
| Description | The import of modern and traditional medicines must be registered by the department of food and drug, ministry of public health. |
| Comments | to easy the management and inspection process and be able to control from the production to the distribution process to ensure the safety, efficiency, and quality of the treatment. |
| Validity From | 2003-08-13 |
| Validity To | 9999-12-31 |
| Reference | Article 4 and 10 (section 4) of Provision no. 1441/MOH, Article 28 of Decision 1820/MOH, Article 16 (para 1) of Law no. 07/NA |
| Technical Code | |
| Measure Type | Registration Requirement |
| Agency | Ministry of Health |
| Legal Document | - Regulation Governing Drug Registration 1441/MOH - Law on Drugs and Medical Products No. 07/NA, dated 21 December 2011 - Decision on business establishment on medicines and medical equipment (Revised Version) no.1820/MoH, dated 25 August 2017. |
| Is Standard | No |
| UN Code | B81 |
| Measure Class | Good |
| Created Datetime | 2012-02-07 12:53:21 |
| Updated Datetime | 2023-07-17 15:06:09 |
Procedures
| # | Procedure Name | Description | Category | View Detail |
|---|---|---|---|---|
| 1 | Registration and Import of Drugs, Cosmetics and Traditional Medicines | Procedure for registering drugs prior to importation and Traditional Medicines. Cosmetics require Registration but do not require an Import License or Permit. | General |
Forms
| # | Title | Description | Issued By | File |
|---|---|---|---|---|
| 1 | Request for importation of drug samples for registration in Lao PDR. | Request Request for importation of drug samples for registration in Lao PDR.Drug Sample | Ministry of Health | |
| 2 | Checklist of Requirements for Drug Registration | Checklist of Requirements for Drug Registration | Ministry of Health | |
| 3 | Checklist of Requirements for Drug Re-registration | Checklist of Requirements for Drug Re-registration | Ministry of Health |
Commodity/s
| # | HS Code | Description |
|---|---|---|
| 1 | 3001200000 | - Extracts of glands or other organs or of their secretions |
| 2 | 3001900000 | - Other |
| 3 | 3002900000 | - Other |
| 4 | 3003101000 | - - Containing amoxicillin (INN) or its salts |
| 5 | 3003102000 | - - Containing ampicillin (INN) or its salts |
| 6 | 3003109000 | - - Other |
| 7 | 3003200000 | - Other, containing antibiotics |
| 8 | 3003310000 | - - Containing insulin |
| 9 | 3003390000 | - - Other |
| 10 | 3003900000 | - Other |
| 11 | 3004101500 | - - - Containing penicillin G (excluding penicillin G benzathine), phenoxymethyl penicillin or salts thereof |
| 12 | 3004101600 | - - - Containing ampicillin, amoxycillin or salts thereof, of a kind taken orally |
| 13 | 3004101900 | - - - Other |
| 14 | 3004201000 | - - Containing gentamycin, lincomycin, sulfamethoxazole or their derivatives, of a kind taken orally or in ointment form |
| 15 | 3004203100 | - - - Of a kind taken orally |
| 16 | 3004203200 | - - - In ointment form |
| 17 | 3004203900 | - - - Other |
| 18 | 3004207100 | - - - Of a kind taken orally or in ointment form |
| 19 | 3004207900 | - - - Other |
| 20 | 3004209100 | - - - Of a kind taken orally or in ointment form |
| 21 | 3004209900 | - - - Other |
| 22 | 3004310000 | - - Containing insulin |
| 23 | 3004321000 | - - - Containing dexamethasone or their derivatives |
| 24 | 3004324000 | - - - Containing hydrocortisone sodium succinate or fluocinolone acetonide |
| 25 | 3004329000 | - - - Other |
| 26 | 3004390000 | - - Other |
| 27 | 3004501000 | - - Of a kind suitable for children, in syrup form |
| 28 | 3004502100 | - - - Of a kind taken orally |
| 29 | 3004502900 | - - - Other |
| 30 | 3004509100 | - - - Containing vitamin A, B or C |
| 31 | 3004509900 | - - - Other |
| 32 | 3004901000 | - - Transdermal therapeutic system patches for the treatment of cancer or heart diseases |
| 33 | 3004902000 | - - Closed sterile water for inhalation, pharmaceutical grade |
| 34 | 3004903000 | - - Antiseptics |
| 35 | 3004904100 | - - - Containing procaine hydrochloride |
| 36 | 3004904900 | - - - Other |
| 37 | 3004905100 | - - - Containing acetylsalicylic acid, paracetamol or dipyrone (INN), of a kind taken orally |
| 38 | 3004905300 | - - - Containing diclofenac, of a kind taken orally |
| 39 | 3004905400 | - - - Containing piroxicam (INN) or ibuprofen |
| 40 | 3004905500 | - - - Other, in liniment form |
| 41 | 3004905900 | - - - Other |
| 42 | 3004906200 | - - - Containing primaquine |
| 43 | 3004906900 | - - - Other :- - - - Other |
| 44 | 3004907100 | - - - Containing piperazine or mebendazole (INN) |
| 45 | 3004907200 | - - - Other :- - - - Other : Herbal medicaments |
| 46 | 3004907900 | - - - Other :- - - - Other : Other |
| 47 | 3004908100 | - - - Containing deferoxamine, for injection |
| 48 | 3004908200 | - - - Anti HIV/AIDS medicaments |
| 49 | 3004908900 | - - - Other |
| 50 | 3004909100 | - - - Containing sodium chloride or glucose, for infusion |
| 51 | 3004909200 | - - - Containing sorbitol or salbutamol, for infusion |
| 52 | 3004909300 | - - - Containing sorbitol or salbutamol, in other forms |
| 53 | 3004909400 | - - - Containing cimetidine (INN) or ranitidine (INN) other than for injection |
| 54 | 3004909500 | - - - Containing phenobarbital, diazepam or chlorpromazine, other than for injection or infusion |
| 55 | 3004909600 | - - - Nasal-drop medicaments containing naphazoline, xylometazoline or oxymetazoline |
| 56 | 3004909800 | - - - - Other : Herbal medicaments |
| 57 | 3004909900 | - - - - Other : Other |
| 58 | 3005101000 | - - Impregnated or coated with pharmaceutical substances |
| 59 | 3005109000 | - - Other |
| 60 | 3005901000 | - - Bandages |
| 61 | 3005902000 | - - Gauze |
| 62 | 3005909000 | - - Other |
| 63 | 3006101000 | - - Sterile absorbable surgical or dental yarn; sterile surgical or dental adhesion barriers, whether or not absorbable |
| 64 | 3006109000 | - - Other |
| 65 | 3006301000 | - - Barium sulphate, of a kind taken orally |
| 66 | 3006302000 | - - Reagents of microbial origin, of a kind suitable for veterinary biological diagnosis |
| 67 | 3006303000 | - - Other microbial diagnostic reagents |
| 68 | 3006309000 | - - Other |
| 69 | 3006401000 | - - Dental cements and other dental fillings |
| 70 | 3006402000 | - - Bone reconstruction cements |
| 71 | 3006500000 | - First-aid boxes and kits |
| 72 | 3006600000 | - Chemical contraceptive preparations based on hormones, on other products of heading 29.37 or on spermicides |
| 73 | 3006700000 | - Gel preparations designed to be used in human or veterinary medicine as a lubricant for parts of the body for surgical operations or physical examinations or as a coupling agent between the body and medical instruments |
| 74 | 3006910000 | - - Appliances identifiable for ostomy use |
| 75 | 3006921000 | - - - Of medicaments for the treatment of cancer, HIV/AIDS or other intractable diseases |
| 76 | 3006929000 | - - - Other |
Step-by-Step Guide
| # | Process name | Process short name | Activity |
|---|
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