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Conveyance of Goods across the Customs Border by Natural Persons for Personal, Family-Related, Household and Other Needs Not Associated with Person’s Entrepreneurial Activities

1. The goods declared for personal, family-related, household and other needs which are not associated with entrepreneurial activities of natural persons (hereinafter, for personal use), shall be conveyed across the customs border by said persons pursuant to the provisions stipulated by Russian Customs Code.

2. The purpose of goods shall be determined by the customs authorities proceeding from the declaration made by the natural person concerned with regard to the goods conveyed across the customs border, the

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

goods’ nature, quantity, as well as frequency of their conveyance across the border.

3. Conveyance across the customs border by natural persons of the goods declared for their personal use predicates the goods complete exemption from customs duties and taxes, application to them of general rates of customs duties and taxes, charging of dutiable payments in the form of a combined payment, as well as the goods’ exemption from the restrictions and prohibitions of economic nature stipulated by the Federal Law of the Russian Federation on the State Regulation of Foreign Trade Activities, mandatory confirmations of the goods conformity, and application of the simplified customs registrati

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

on procedure.

Importation and Exportation of Goods and Means of transport for Personal Use and Application of Customs Duties and Taxes to Such Goods and Means of transport

1. Imported goods shall be exempted from customs duties and taxes partially or completely provided the overall value of the goods imported to the customs territory of the Russian Federation, except means of transport, amounts to not more than 65,000.00 roubles.

The values of means of transport and/or goods above 65,000.00 roubles but not exceeding 650,000.00 roubles shall be charged general rates of customs duties and taxes. The order of application of said general rates of customs duties and taxes is determined

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

y the Government of the Russian Federation based on the average established rates of customs duties and taxes levied on the goods and means of transport whose categories are conveyed across the customs border in greatest quantities.

Complete exemption from customs duties and taxes or levying of the general rates of customs duties and taxes shall be applied in the quantitative limits established by the Government of the Russian Federation.

2. The Government of the Russian Federation has the right to impose quantity and cost restrictions on the goods imported by natural persons with complete exemption from customs duties and taxes or with application of the general rates of customs du

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

ties and taxes with regard to the goods liable for excise taxes and the goods subject to quantitative restrictions on their importation to the Russian Federation pursuant to the Federal Law on Measures for Protecting Economic Interests of the Russian Federation in Foreign Trade Operations with Goods and Commodities.

3. The Government of the Russian Federation has the right to determine those instances when complete exemption from customs duties and taxes is not granted, or is applied with limitations to the goods conveyed to the customs territory of the Russian Federation by underage natural persons, as well as the natural persons who frequently cross the customs border.

4. The Gove

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

rnment of the Russian Federation has the right to determine those instances when complete exemption from customs duties and taxes or the general rates of customs duties and taxes are applied in the amounts exceeding the limits stipulated by Item 1 herein with regard to the goods conveyed across the border by natural persons at the instance of their resettlement to a new place of permanent residence, the goods moved by refugees or forced migrants, as well as with regard to inherited property.

5. Goods of cultural value imported to the customs territory of the Russian Federation shall be completely exempt from customs duties and taxes at the instance of their written declaration, as we

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

l as their special registration stipulated by the Law of the Russian Federation on Importation and Exportation of Cultural Values.

6. Goods imported to or exported from the customs territory of the Russian Federation in accordance with Russian Customs Code shall be regarded for customs clearance purposes, respectively, as goods released for free circulation or goods exported pursuant to the customs export procedure.

7. Goods exported by natural persons will be exempted from dutiable payments or the domestic taxes levied thereon redeemed in accordance with the regulations set forth in the Russian legislation on taxes and duties.

8. The provisions of Russian Customs Code shall not ap

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

ply to goods temporarily imported (exported) or re-exported (re-imported) by natural persons.

Note: for the purpose of application of Russian Customs Code, a means of transport shall be defined as motor vehicles and trailers, seagoing vessels (riverboats) or aircraft complete with spare parts, tools and appliances thereto imported and exported by natural persons for their personal use.

Temporary Importation of Goods by Natural Persons

1. Goods temporarily imported to the customs territory of the Russian Federation by foreign natural persons shall be completely exempted from customs duties and taxes provided these goods are imported exclusively for personal use by said persons throu

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

ghout the period of their temporary stay in the customs territory of the Russian Federation.

2. The exemption from customs duties and taxes stipulated by Item 1 herein applies to means of transport owned, rented, or otherwise hired for personal use by foreign natural persons, which are imported to the customs territory of the Russian Federation concurrently, prior to, or after the entry of said foreign person to the customs territory of the Russian Federation.

The means of transport conveyed across the customs border by natural persons for the purpose of paid haulage of person or for commercial or industrial haulage of cargoes shall be conveyed across the customs border based on the

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

rules stipulated by Russian Customs Code.

3. In case temporarily imported goods are subject to a written declaration as Russian Customs Code, the time limits of their temporary importation shall be prescribed by the customs authorities proceeding from the declaration made by said foreign natural persons with consideration of his (or her) intended duration of stay in the Russian Federation within the time limits established by the Government of the Russian Federation as per Item 4 herein.

Upon a motivated request by a foreign natural person, the time term of goods temporary importation prescribed by the customs authorities may be extended within the time limits established by the Gov

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

ernment of the Russian Federation as per Item 4 herein

4. The Government of the Russian Federation has the right to prescribe the time limits for temporary importation of specific categories of goods including the means of transport, which are temporarily imported to the customs territory of the Russian Federation by foreign natural persons.

5. Temporarily imported goods may be re-exported from the customs territory of the Russian Federation through any customs border gate. At the instance of their re-exportation, temporarily imported goods shall be exempt from customs duties and taxes or free from any restrictions of economic nature stipulated by the Federal Law of the Russian Fede

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

ration on the State Regulation of Foreign Trade Activities.

6. Re-exportation of temporarily imported goods, including means of transport, may be unnecessary is said goods, including means of transport, have been seriously damaged as a result of an accident or force majeure.

7. Russian natural persons have the right to temporarily import means of transport provided said means of transport are registered in the territory of a foreign country and their aggregate terms of temporary importation do not exceed six months within a single a single calendar year with regard to each imported means of transport.

Customs Registration of Goods Conveyed across the Customs Border by Natural Perso

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

s for Personal Use

1. Customs registration of the goods conveyed across the border by a natural person for personal use shall be regulated by the order determined by the Government of the Russian Federation in conformity with Russian Customs Code.

2. Natural persons crossing the customs border in their owned motor vehicles, as well as inside commercial motor vehicles or on board a train, as a rule, may complete all requisite customs formalities without leaving said vehicles.

3. The goods, including means of transport conveyed across the border by natural persons, shall be subject to placement in a temporary-storage warehouse in the following instances:

(1) upon request by said per

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

sons;

(2) when instant completion of the goods customs registration formalities and/or payment of customs duties and taxes thereon becomes impossible due to reasons beyond the customs authorities’ control.

4. Temporary storage of goods is effected in accordance with the procedure specified by Russian Customs Code at the expense of the person whose goods have been placed in a temporary-storage warehouse.

5. With a view to simplifying the customs registration formalities with the goods conveyed by natural persons using motor vehicles or by railway, the Federal Customs Authority shall conclude agreements with the customs authorities of the bordering countries with regard to effecting

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

joint customs registration formalities and customs control of said goods.

Declaration of Goods by Natural Persons

1. Declaration of goods conveyed across the border by natural persons as their hand luggage or attended baggage shall be performed at the instance of their crossing the border gate at the State Border of the Russian Federation.

2. Liable for declaration shall be goods, including means of transport:

(1) which are conveyed by natural persons as unattended baggage;

(2) which are dispatched to the address of natural persons for their personal use, except the goods dispatched by international mail;

(3) whose importation is restricted pursuant to Russian law or whose value

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

and/ quantity exceed the limits established for conveyance across the customs territory of the Russian Federation of the goods enjoying complete exemption from customs duties and taxes;

(4) whose exportation is restricted pursuant to Russian law;

(5) whose mandatory written declaration at the instance of exportation is stipulated by Russian law;

(6) means of transport.

3. In the instances which are not specified in Item 2 herein, the goods are declared orally. A natural person, upon his (or her) wish, has the right to declare in writing the goods conveyed across the customs border, which are not liable for mandatory written declaration.

4. In the cases and according to the proc

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

edures prescribed by the Federal Customs Authority, goods liable for oral declaration shall be declared by performing actions proving that neither the person’s hand luggage nor the attended baggage contains any goods liable for written declaration (declaration in contracting bargain form). For this purpose the customs border is equipped with the corridors for natural persons specially designated so that a person may make a conscious choose of the form of declaration of his (or her) goods. Passage of a natural person through the gate specially designated for the persons who have no goods in his (or her) hand luggage or attended baggage liable for written declaration shall be regarded a

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

s a declaration to the customs authorities of the fact that said natural person carries no goods liable for written declaration.

5. The goods in possession of underage persons below sixteen years old shall be declared by the person’s accompanying parent, stepparent, guardian, or trustee, or by a group leader in the instance of an organised exit (entry) or return entry (exit) of a group of underage persons unaccompanied by parents, stepparents, guardians, or trustees.

6. A written customs declarations pertaining to the goods conveyed across the customs border in unattended baggage should be submitted to the customs authorities within the time limits specified in Russian Customs Code

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

n case of their importation to the customs territory of the Russian Federation, or concurrently with presentation of goods for inspection to the customs authorities in case of their exportation.

The goods conveyed across the customs border in unattended baggage may be declared by the person who is conveying said goods, or by another person acting upon the power of attorney of the person conveying said goods across the customs border.

The goods contained in the unattended baggage of an underage person below sixteen years old should be declared by his (or her) parent, stepparent, guardian, or trustee, or by a person acting upon a power of attorney of said persons.

Dutiable Payments b

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

y Natural Persons

1. Dutiable payments shall be made by natural persons at the instance of filling out their written customs declarations with regard to their goods based on the customs receipt whose form is approved by the Federal Customs Authority. One copy of the receipt is handed to the person responsible for customs payments.

2. The customs duties and taxes levied on the goods conveyed across the border for personal use shall be made by natural persons in the form of a combined customs payment (payment to be made as a lump amount without dividing it into specific customs duties and taxes) or in the form of a customs payment based on the general rates of customs duties and taxes

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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An article covering 3 steps - determining interests, niche markets and goals - vital to starting an import/export business.

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