Application for Advance Ruling for Sideral Drops and Forte

Janron Consult - Customs Tax News - Clients Work 2022-Case Studies - Application for Advance Ruling for Sideral Drops and Forte

5th  August,2023

 

The Chief Manager, Business Intelligence & Analysis

Kenya Revenue Authority

Times Towers

Nairobi, Kenya

 

Dear Madam,

 

REF: Application for Advance Ruling for Sideral Drops and Forte

We are writing on behalf of our principal, Austell Pharmaceuticals (Pty) Ltd,  to request for a HS classification, advance ruling,  for 2 Products namely (1) SIDERAL® DROPS Int.   (2) SIDERAL® FORTE 15 capsules

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:

The application for the two products has been put up in one document because the legal notes for both products are similar.

Description of SIDERAL® DROPS Int.  

What SIDERAL® DROPS Int. contains: Stick Ingredients: SIDERAL® r.m. – Sucrosomial® Iron (7 mg/mL) (iron pyrophosphate, sucrose esters of fatty acids, pregelatinized rice starch, sunflower lecithin spray-dried on rice flour and tricalcium phosphate), maltodextrins.

 

Ingredients after Reconstitution(Dilution)

Bottle Ingredients: Purified water, sucrose, maltodextrins, flavour, preservatives: potassium sorbate (0,126 %

m/v) and sodium benzoate (0,08 % m/v); thickening agent: xanthan gum, acidity regulator: citric acid, emulsifier: sucrose esters of fatty acids.

Gluten Free. Contains milk proteins. Lactose free

When reconstituted as directed, each mL contains 7 mg Sucrosomial® Iron.

Contains sweetener: Sucrose 287,05 mg.  Contains milk proteins. Lactose free

Uses of the SIDERAL® DROPS Int

SIDERAL® DROPS Int. is used for iron deficiency states and aids in the normal formation of red blood cells and haemoglobin. SIDERAL® DROPS Int. 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 SIDERAL® DROPS Int. 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. The product has been put up for children.

 

Description of SIDERAL® FORTE 15 capsules

What SIDERAL® FORTE 15 contains, SideraI®r. m. -Sucrosomial® Iron (15 mg/capsule) (iron pyrophosphate, pregelatinised rice starch, sucrose esters of fatty acids, sunflower lecithin on glucose syrup carrier, milk proteins, tricalcium phosphate), food-grade gelatin, bulking agent: microcrystalline cellulose; Vitamin C

(L-ascorbic acid), hydroxypropylmethylcellulose; anti-caking agents: vegetal magnesium stearate, silicon dioxide; colouring agents: red iron oxide, titanium dioxide.

SIDERAL® FORTE 15 capsules contain Sucrosomial® Iron 15 mg and Vitamin C 45 mg. Contains milk proteins. Lactose free. Gluten free.

Uses of the SIDERAL® FORTE 15

SIDERAL® FORTE 15 is used for iron deficiency states and aids in the normal formation of red blood cells and haemoglobin. SIDERAL® FORTE 15 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 SIDERAL® FORTE 15 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

 

The two products have been put up as medicaments to treat iron deficiency and aid in the normal formation of red blood cells and haemoglobin.

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 :

(2)    All goods of Chapter 28 or 29; and

 

Chapter 30 covers unmixed goods, the active components in the products are iron pyrophosphate and vitamins and excipients.  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.

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.

3003.10 – Containing penicillins or derivatives thereof, with a penicillanic acid structure, or streptomycin’s or their derivatives

3003.20 – Other, containing antibiotics

3003.31 – – Containing insulin

3003.39 – – Other

3003.41 – – Containing ephedrine or its salts

3003.42 – – Containing pseudoephedrine (INN) or its salts

3003.43 – – Containing norephedrine or its salts

3003.49 – – Other

3003.60 – Other, containing antimalarial active principles described in Subheading Note 2 to this Chapter

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 products are 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.

3004.10 – Containing penicillins or derivatives thereof, with a penicillanic acid structure, or streptomycin’s or their derivatives

3004.20 – Other, containing antibiotics

3004.31 – – Containing insulin

3004.32 – – Containing corticosteroid hormones, their derivatives, or structural analogues

3004.39 – – Other

3004.41 – – Containing ephedrine or its salts

3004.42 – – Containing pseudoephedrine (INN) or its salts

3004.43 – – Containing norephedrine or its salts

3004.49 – – Other

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 injectable 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.

The products satisfy 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.

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).

 

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 products are iron pyrophosphate and Vitamin C 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 do not impart 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

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.

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.

 

 

 

 

World Customs Organisation(WCO) Ruling for Subheading 3004.50.

  1. 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 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.
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.

 

From our assessment, the two products  (1) SIDERAL® DROPS Int.   (2) SIDERAL® FORTE 15 capsules, 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