5th August,2023
The Chief Manager, Business Intelligence & Analysis
Kenya Revenue Authority
Times Towers
Nairobi, Kenya
Dear Madam,
REF: Application for Advance Ruling for QUADROFER sachets
We are writing on behalf of our principal, Austell Pharmaceuticals (Pty) Ltd, to request for a HS classification, advance ruling, for QUADROFER mouth-dispersible stick packs (sachets). The application is done ,as per section 248(A) of EACCMA. Our proposed HS Classification is 3004.50.00
The structure of the application consists of:
- Description of the functions of the product
- Extracts from the applicable legal notes, followed by our analysis, highlighted in red and enclosed in a text box. The most important Explanatory Notes are underlined.
Description of QUADROFER sachets
Each stick pack (sachet) contains:
Iron 21,00 mg , Vitamin C 70,00 mg, Folic Acid 400,00 mcg, Vitamin D3 10,00 mcg, Vitamin B12 1,75 mcg, Vitamin B6 1,00 mg.
The other ingredients are sweeteners: acesulfame K 0,576 mg; sorbitol 1130,688 mg; sucralose 0,896 mg; xylitol 160 mg. Contains milk proteins. Lactose free. Gluten free.
What QUADROFER contains
SideraI® r. m. – Sucrosomial® Iron (21 mg/stick pack) (iron pyrophosphate, pregelatinized rice starch, sucrose esters of fatty acids, sunflower lecithin on glucose syrup carrier, milk proteins, tricalcium phosphate), sorbitol, xylitol, vitamin C (L-ascorbic acid), flavours, citric acid, vitamin D3 (cholecalciferol, medium chain triglycerides, Arabic gum, sucrose, starch, DL-alpha tocopherol, tricalcium phosphate), vitamin B12 (cyanocobalamin, citric acid, maltodextrin, trisodium citrate), sucralose and acesulfame K, vitamin B6 (pyridoxine hydrochloride), folic acid (pteroyl-monoglutammic acid)
QUADROFER is used for iron deficiency states and aids in the normal formation of red blood cells and haemoglobin. QUADROFER is a preparation of iron that is conveyed inside a sucrosomial® membrane and is therefore highly available for absorption. Sucrosomial® technology protects oral and gastrointestinal mucosa from the oxidising action of iron, therefore avoiding metallic taste, gastric discomfort, mucous tissue and stool staining. In fact, the iron contained in QUADROFER never comes in contact with the mucous tissues of the body; therefore, it presents a high degree of gastrointestinal tolerability reducing the risk of gastrointestinal irritation.
Please refer to the Patient Information Leaflet and the Product Sample for more information
Chapter 30: Pharmaceutical products: Explanatory Notes
3.- For the purposes of headings 30.03 and 30.04 and of Note 4 (d) to this Chapter, the following are to be treated :
(a) As unmixed products :
| Chapter 30 covers unmixed goods, the active components in the product are iron pyrophosphate and Vitamins C, Folic Acid, D3, B12, B6. They are all classified in headings 28.35 or 29.36. They are therefore considered as unmixed goods classifiable in chapter 30 when put up for therapeutic and prophylactic purpose. |
(2) All goods of Chapter 28 or 29; and
Heading 30.03 Explanatory Notes
30.03 – 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.
3003.90 – Other
This heading covers medicinal preparations for use in the internal or external treatment or prevention of human or animal ailments. These preparations are obtained by mixing together two or more substances. However, if put up in measured doses or in forms or packings for retail sale, they fall in heading 30.04.
| Heading 30.03 covers medicinal preparations for use in the internal or external treatment or prevention of human or animal ailments. These preparations are obtained by mixing together two or more substances. The instant product is a mixture of two or more products as per the patient information leaflet. It is used for treatment of iron deficiency and aids in the normal formation of red blood cells and haemoglobin. Heading 30.03 covers nonretail products, but similar to those of heading 30.04. The products functions are therefore completely described by heading 30.03/30.04 |
The heading includes :
(1) Mixed medicinal preparations such as those listed in an official pharmacopoeia, proprietary medicines, etc., including those in the form of gargles, eye drops, ointments, liniments, injections, counter-irritant and other preparations not falling in heading 30.02, 30.05 or 30.06.
(2) Preparations containing a single pharmaceutical substance together with an excipient, sweetening agent, agglomerating agent, support, etc.
On the other hand, the heading covers preparations in which the foodstuff or the beverage merely serves as a support, vehicle, sweetening agent or a processing or technical aid for the medicinal substances (e.g., in order to facilitate ingestion).
Heading 30.04 Explanatory Notes
30.04 – 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.
3004.50 – Other, containing vitamins or other products of heading 29.36
3004.60 – Other, containing antimalarial active principles described in Subheading Note 2 to this Chapter
3004.90 – Other
This heading covers medicaments consisting of mixed or unmixed products, provided they are :
(a) Put up in measured doses or in forms such as tablets, ampoules (for example, re-distilled water, in ampoules of 1.25 to 10 cm3, for use either for the direct treatment of certain diseases, e.g., alcoholism, diabetic coma or as a solvent for the preparation of injectible medicinal solutions), capsules, cachets, drops or pastilles, medicaments in the form of transdermal administration systems, or small quantities of powder, ready for taking as single doses for therapeutic or prophylactic use.
The heading also includes measured doses in the form of transdermal administration systems which are generally put up in the form of self-adhesive patches (usually rectangular or round) and which are applied directly to the skin of patients. The active substance is contained in a reservoir which is closed by a porous membrane on the side entering into contact with the skin. The active substance released from the reservoir is absorbed by passive molecular diffusion through the skin and passes directly into the bloodstream. These systems should not be confused with medical adhesive plasters of heading 30.05.
The heading applies to such single doses whether in bulk, in packings for retail sale, etc.; or
(b) In packings for retail sale for therapeutic or prophylactic use. This refers to products (for example, sodium bicarbonate and tamarind powder) which, because of their packing and, in particular, the presence of appropriate indications (statement of disease or condition for which they are to be used, method of use or application, statement of dose, etc.) are clearly intended for sale directly to users (private persons, hospitals, etc.) without repacking, for the above purposes.
These indications (in any language) may be given by label, literature or otherwise. However, the mere indication of pharmaceutical or other degree of purity is not alone sufficient to justify classification in this heading.
On the other hand, even if no indications are given, unmixed products are to be regarded as being put up for retail sale for therapeutic or prophylactic use if they are put up in a form clearly specialised for such use.
Medicaments consisting of mixed products for therapeutic or prophylactic uses and not put up in measured doses or in forms or packings for retail sale are classified in heading 30.03 (see the corresponding Explanatory Note).
| The product satisfies conditions a and b of heading 30.04 explanatory notes extracted above, in the context of: measured doses, for direct treatment of certain diseases, in packings for retail sale for therapeutic use, presence of appropriate indications. Refer to the Patient information Leaflet as well as samples of the product. |
Under the terms of Chapter Note 3, the following are also regarded as unmixed products :
(1) Unmixed products dissolved in water.
| Heading 30.04 covers unmixed goods, the active components in the product are iron pyrophosphate and Vitamins C, Folic Acid, D3, B12, B6. They are all classified in headings 28.35 or 29.36. They are therefore considered as unmixed goods classifiable in heading 30.04, when put up for therapeutic and prophylactic purpose. |
(2) All goods of Chapter 28 or 29. Such products include colloidal sulphur and stabilised solutions of hydrogen peroxide.
On the other hand, the heading covers preparations in which the foodstuff or the beverage merely serves as a
support, vehicle, sweetening agent or a processing or technical aid for the medicinal substances (e.g., in order
| The Explanatory note above clarifies that the other inactive ingredients/excipients are allowable as part of therapeutic or prophylactic preparations and do not alter classification in heading 30.04 as long as they are not the ones imparting the essential character to the product. |
to facilitate ingestion).
Section VI: PRODUCTS OF THE CHEMICAL OR ALLIED INDUSTRIES: Explanatory Notes
2.- Subject to Note 1 above, goods classifiable in heading 30.04, 30.05, 30.06, 32.12, 33.03, 33.04, 33.05, 33.06, 33.07, 35.06, 37.07 or 38.08 by reason of being put up in measured doses or for retail sale are to be classified in those headings and in no other heading of the Nomenclature.
Note 2. Explanatory Notes
Section Note 2 provides that goods (other than those described in heading 28.43 to 28.46 or 28.52) which are covered by heading 30.04, 30.05, 30.06, 32.12, 33.03, 33.04, 33.05, 33.06, 33.07, 35.06, 37.07 or 38.08 by reason of being put up in measured doses or for retail sale, are to be classified in those headings notwithstanding that they could also fall in some other heading of the Nomenclature. For example, sulphur put up for retail sale for therapeutic purposes is classified in heading 30.04 and not in heading 25.03 or 28.02, and dextrin put up for retail sale as a glue is classified in heading 35.06 and not in heading 35.05.
| The section VI note extracted above rules out classification in any other heading of the nomenclature if a product is put up for therapeutic or prophylactic application(heading 30.04) and is put up in measured doses. Note the reasons: put up in measured doses The instant product is put up in measured doses can be confirmed from the sample provided to KRA. It is correctly classifiable in heading 30.04, therefore the product cannot be classified in any other heading in the nomenclature. |
World Customs Organisation(WCO) Ruling for Subheading 3004.50.
| The WCO ruling extracted above supports our assertion that iron salts and combination of essential vitamins put up for therapeutic or prophylactic purpose are to be classified under subheading 3004.50. |
- Liquid preparation composed of ferric ammonium citrate, vitamin B12, folic acid, sorbitol solution, alcohol (3.61 %), raspberry flavour and adequate proportions of different vitamins, used as a blood builder in the treatment of nutritional or hypochromic anaemia. Adoption : 1996
| The products therapeutic attributes described above and in the patient information leaflet is evidence-based with proven clinical studies on the safety, efficacy, and unique mode of action. The clinical trials are available upon request. All products imported into Kenya will be detailed to HCP (Healthcare Professionals), and will be prescription driven, stock will only be supplied to pharmacies, hospitals and others as approved by the Poisons and Pharmacy Board. Professional medical sales representatives will be trained on the products. The supply model described above is used for all allopathic medicine. |
We hereby enclose copies of the following documents for your reference.
- Patient Information Leaflet
- Sample of QUADROFER mouth-dispersible stick packs (sachets
| From our assessment, the QUADROFER mouth-dispersible stick packs (sachets should be classified under heading 30.04 which covers {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. The specific subheading will be 3004.50.00 |
Our Technical experts will be readily available for any clarification required.
In light of the above, we kindly request you to guide us on the suitable tariff classification for above-mentioned product.
Thanking you for your valued consideration.
Yours faithfully,
Charles Mukangu
Janron Consult
Email: mmc@janronconsult.com
Phone: +254708751955
