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  • Useful Advices - Primary Customs Procedures in Russia

    1. Release for Domestic Consumption
    Release of goods for domestic consumption constitutes a customs procedure under which the goods imported to the customs territory of the Russian Federation shall remain on that territory with any obligations to be exported from said territory.
    Status of Goods Subject to the Customs Procedure of Release for Domestic Consumption:
    1. For customs purpose
    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
    s, imported merchandise will acquire the status of goods released for free circulation in the customs territory of the Russian Federation upon disbursement of all the requisite customs duties and taxes and observance of the restrictions and prohibitions pursuant to the Federal Law of the Russian Federation on the State Regulation of Foreign Trade Activities.
    2. In case of non-observance of said
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    terms and conditions, imported merchandise shall be liable for conditional release pursuant to Russian Customs Code.



    2. Export
    Export constitutes a customs procedure under which the goods in free circulation in the customs territory of the Russian Federation are exported from this territory without any obligations to import them back.
    Terms and Conditions of Subjecting Goods to a C
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    ustoms Procedure:
    1. Export of goods is effected upon disbursement of all the requisite export customs duties, observance of the economic restrictions and prohibitions stipulated by the requirements of the Federal Law of the Russian Federation on the State Regulation of Foreign Trade Activities, and fulfilment of any other terms and conditions set forth by Russian Customs Code, other federal stat
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    utes and legal norms of the Russian Federation.
    2. The goods exported in compliance with the customs export procedure shall be exempted from domestic taxes; the domestic taxes levied thereto shall be redeemed or reimbursed pursuant to the Russian legislation on taxes and duties.



    3. International Customs Transit
    International customs transit constitutes a customs procedure under whi
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    h foreign goods transit the customs territory of the Russian Federation in customs custody between the point of their entry to and departure from the customs territory of the Russian Federation (if said transit constitutes a leg of their itinerary which begins and ends outside the boundaries of the customs territory of the Russian Federation) exempt from any customs taxes and duties or application of a
    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
    ny economic restrictions and prohibitions of economic nature stipulated by the Federal Law of the Russian Federation on the State Regulation of Foreign Trade Activities.
    Terms and Conditions of Subjecting Goods to the Customs Procedure:
    1. Subject to the customs procedure of international customs transit may be any foreign merchandise except the goods whose transit is prohibited pursuant to
    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
    federal laws, other statutes, and legal norms of the Russian Federation and the international treaties to which the Russian Federation is party.
    2. Federal laws, other statutes, and legal norms of the Russian Federation and the international treaties of the Russian Federation may establish additional terms and conditions stipulating placement of merchandise under the customs procedure of interna
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    tional customs transit.
    Application to International Customs Transit of Rules and Requirements Applicable to Domestic Customs Transit in accordance with Russian Customs Code:
    1. Under conditions of international customs transit, issuance of permissions for international customs transit, as well as the rules stipulating the time limits for effecting international customs transit, identificat
    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
    ion of merchandise, measures ensuring fulfilment of the statutes of the customs legislation of the Russian Federation shall be exercised by customs authorities pursuant to the provisions contained in Russian Customs Code regulating domestic customs transit and applicable to the international customs transit procedure.
    2. The rights, obligations, and responsibility of the carrier or forwarder unde
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    the conditions of international customs transit shall be regulated by the provisions of Russian Customs Code.
    Transhipment of International Transit Merchandise and Other Operations with Transit Merchandise:
    1. Transhipment of international transit merchandise from a means of transport by which said merchandise was imported to the customs territory of the Russian Federation to a means of tr
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    ansport that will carry said merchandise from this territory shall be effected upon permission in that regard issued by the customs office in whose region this transhipment occurs. If transhipment of transit goods from one means of transport to another may be effected without damaging any customs seals and stamps affixed to the merchandise, it may be effected with a preliminary notification of the cust
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    oms office concerned.
    2. Temporary placement of transit merchandise in warehouses (storage, breaking up, or accumulation of lots, and other operations) in the customs territory of the Russian Federation is permissible provided all terms and conditions stipulated by Russian Customs Code are observed.
    3. Any operations with merchandise under the international customs transit procedure, which
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    are not stipulated by Items 1 and 2 herein, may only be conducted in the event of a real threat of destruction, loss, irretrievable loss, or major damage pending to merchandise and/or a means of transport.
    Completion of the Customs Procedure:
    1. The customs transit procedure is completed at the instance of exportation of transit merchandise from the customs territory of the Russian Federati
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    on.
    The carrier shall be obliged to present transit merchandise for inspection, submit a customs declaration and other documents pertaining to merchandise international customs transit to the customs authorities at the point of destination. The customs office concerned shall be obliged to perform all the operations required for the completion of the international customs transit procedure and iss
    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
    e permission for the departure of goods and means of transport from the customs territory of the Russian Federation on the day of presentation of transit merchandise and submission of requisite documents. In case of exportation of transit merchandise by separate lots, the international customs transit procedure shall be regarded as completed upon the departure of the last lot thereof from the customs
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    territory of the Russian Federation.
    2. The international customs transit procedure may also be completed at the instance of placement of merchandise under other customs procedures provided all requirements stipulated by Russian Customs Code are observed.
    Peculiarities of Application of the Customs Transit Procedure:
    1. In those instances when the point of entry of merchandise and me
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    ans of transport to the customs territory of the Russian Federation coincides with the point of its departures from said territory the international customs transit procedure may be simplified. The carrier and the forwarder will only need to present the documents and the information which are required at the instance of arrival of merchandise and means of transport, whereas permission for transit is is
    .

    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
    sued on the day of presentation of merchandise and submission of documents and information to the customs authorities.
    2. In case transit merchandise is transhipped in the place specified in Item 1 herein, i.e., from a means of transport which was used for delivery of merchandise to the means of transport used merchandise departure, transhipment operations may only be permitted by the customs aut
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    horities. The customs authorities may issue such permission to the carrier or forwarder provided the latter have submitted all the documents and information pursuant to Russian Customs Code.
    3. The customs authorities may deny permission for cargo-handling operations with transit merchandise only in case such operations may lead to loss of merchandise or change of its consumer properties.


    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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