| Name | Application for registration and retention of registration of medicinal products |
|---|---|
| Description | Every applicant must, without delay, inform the Board either before or after the registration of a medicinal product whether the medicinal product is to be imported as a finished product into Malawi, or re-labelled. or repackaged or dealt with in any other manner, in Malawi. |
| Comments | This applies in countries where medicine ingredients are found in several countries and medicines are shipped to them at different levels of manufacturing. |
| Validity From | 2007-12-28 |
| Validity To | 9999-12-31 |
| Reference | Pharmacy, Medicines and Poisons (Fees and Forms) Regulations. Regulation 13(3) and (4). |
| Technical Code | |
| Measure Type | Registration Requirement |
| Agency | Poisons Board of Malawi |
| Legal Document | - Pharmacy, Medicines and Poisons Act (35:01) |
| Is Standard | No |
| UN Code | (not set) |
| Measure Class | Good |
| Created Datetime | 2016-01-21 13:30:01 |
| Updated Datetime | 2016-07-06 16:31:14 |
Procedures
| # | Procedure Name | Description | Category | View Detail |
|---|---|---|---|---|
| 1 | Application for registration of medicinal products. | Application for Registration of medicinal Products Under Pharmacy, Medicines and Poisons (Fees and Forms) Regulations. Rule 13(3) and (4). | Procedure |
Forms
| # | Title | Description | Issued By | File |
|---|---|---|---|---|
| 1 | Product License Application | Product License Application | Poisons Board of Malawi | |
| 2 | Pharmaceutical Manufacturing Facility Application | Pharmaceutical Manufacturing Facility Application | Poisons Board of Malawi |
Commodity/s
| # | HS Code | Description |
|---|---|---|
| 1 | 30012000 | EXTRACTS OF GLANDS OR OTHER ORGANS OR OF THEIR SECRETIONS |
| 2 | 30019000 | SUBSTANCES OF HUMAN OR ANIMAL ORIGIN,FOR PROPHYLACTIC USES, NES |
| 3 | 30021000 | -ANTISERA AND OTHER BLOOD FRACTIONS AND MODIFIED IMMUNOLOGICAL PRODUCTS |
| 4 | 30022000 | VACCINES FOR HUMAN MEDICINE |
| 5 | 30023000 | VACCINES FOR VETERINARY MEDICINE |
| 6 | 30029000 | HUMAN AND ANIMAL BLOOD; MICROBIAL CULTURES; TOXINS, ETC, NES |
| 7 | 30031000 | MEDICAMENTS OF PENICILLINS OR STREPTOMYCINS NOT FOR RETAIL SALE |
| 8 | 30032000 | MEDICAMENTS OF OTHER ANTIBIOTICS, NOT FOR RETAIL SALE |
| 9 | 30033100 | MEDICAMENTS OF INSULIN, NOT FOR RETAIL SALE |
| 10 | 30033900 | MEDICAMENTS OF OTHER HORMONES, NOT FOR RETAIL SALE, NES |
| 11 | 30034000 | MEDICAMENTS OF ALKALOIDS OR DERIVATIVES THEREOF, NOT FOR RETAIL SALE |
| 12 | 30039000 | OTHER MEDICAMENTS WITH >=2 CONSTITUENTS, NOT FOR RETAIL SALE, NES |
| 13 | 30041000 | MEDICAMENTS OF PENICILLINS... OR STREPTOMYCINS..., FOR RETAIL SALE |
| 14 | 30042000 | MEDICAMENTS OF OTHER ANTIBIOTICS, FOR RETAIL SALE |
| 15 | 30043100 | MEDICAMENTS OF INSULIN, FOR RETAIL SALE |
| 16 | 30043200 | MEDICAMENTS CONTAINING ADRENAL CORTICOSTERIOD HORMONES,THEIR DERIVATIVES & |
| 17 | 30043900 | MEDICAMENTS OF OTHER HORMONES, FOR RETAIL SALE, NES |
| 18 | 30044000 | MEDICAMENTS OF ALKALOIDS OR DERIVATIVES THEREOF, FOR RETAIL SALE |
| 19 | 30045000 | OTHER MEDICAMENTS OF VITAMINS OR OTHER PRODUCTS OF 29.36 FOR RETAIL SALE |
| 20 | 30049010 | ---MEDICAMENTS FOR THE TRTMENT/PRVENTION OF BILHAZIA AND MALARIA,AMOEB ETC |
| 21 | 30049090 | ---MEDICAMENTS OTHER THAN THOSE FOR TRTMENT/PREVT.OF BILHAZIA,MALARIAETC |
Step-by-Step Guide
| # | Process name | Process short name | Activity |
|---|
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