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  • 1.

    Healthcare bodies
    Describe the bodies and their responsibilities (public and private sector) concerned with the delivery of healthcare and appropriate products for treatment.

  • 2.

    Competent authorities for authorisation
    Identify the competent authorities for approval of the marketing of medicinal products and medical devices. What rules apply to deciding whether a product falls into either category or other regulated categories?

  • 3.

    Approval framework
    Describe the general legislative and regulatory framework for approval of marketing of medicinal products and medical devices.

  • 4.

    Applicable rules
    What legislation controls and which rules apply to ethics committee approval and performance of clinical trials in your territory for medicinal products and medical devices?

  • 5.

    Reporting requirements
    What requirements exist for reporting the commencement of a trial and its results to the competent authorities or the public?

  • 6.

    Consent and insurance
    Are there mandatory rules for obtaining trial subjects’ consent to participate? Must sponsors arrange personal injury insurance to a particular limit?

  • 7.

    Time frame
    How long does it take, in general, to obtain an authorisation from application to grant, what fees are payable and what is the normal period of validity of the authorisation?

  • 8.

    Protecting research data
    What protection or exclusivities apply to the data submitted by originators to gain initial approval and, on variation or new application, to add indications or pharmaceutical forms?

  • 9.

    Freedom of information
    To what extent and when can third parties make freedom of information applications for copies of research data submitted by applicants for authorisation to market medicinal products or medical devices?

  • 10.

    Regulation of specific medicinal products
    Are there specific rules for approval, and rewards or incentives for approval, of particular types of medicinal products, such as traditional herbal and homeopathic products, biologicals and biosimilars, controlled drugs, orphan drugs and those for paediatric use?

  • 11.

    Post-marketing surveillance of safety
    What pharmacovigilance or device vigilance obligations apply to the holder of a relevant authorisation once the product is placed on the market?

  • 12.

    Other authorisations
    What authorisations are required to manufacture, import, export or conduct wholesale distribution and storage of medicinal products and medical devices? What type of information needs to be provided to the authorities with an application, what are the fees, and what is the normal period of validity?

  • 13.

    Sanctions
    What civil, administrative or criminal sanctions can authorities impose on entities or their directors and officers for breach of the requirements concerning controlled activities?

  • 14.

    Exemptions
    What, if any, manufacture and supply of medicinal products is exempt from the requirement to obtain an approval to market?

  • 15.

    Parallel trade
    Are imports allowed into your jurisdiction of finished products already authorised in another jurisdiction, without the importer having to provide the full particulars normally required to obtain an authorisation to market? What are the requirements?

  • 16.

    Variation
    What are the main requirements relating to variation of authorisations for medicinal products and medical devices?

  • 17.

    Renewal
    What are the main requirements relating to renewal of authorisations for medicinal products and medical devices?

  • 18.

    Transfer
    How easy is it to transfer the existing approvals or rights to market medicines and medical devices? How long does this take in general?

  • 19.

    Defective and unsafe products
    What are the normal requirements for handling cases of defective or possibly unsafe products, including approvals required for recall and communication with health professionals?

  • 20.

    Regulation
    Summarise the rules relating to advertising and promotion of medicinal products and medical devices, explaining when the provision of information will be treated as promotional. Do special rules apply to online advertising?

  • 21.

    Inducement
    What regulations exist to discourage the provision of inducements to healthcare professionals to prescribe, sell, supply or recommend use of a particular medicinal product or medical device?

  • 22.

    Reporting transfers of value
    What requirements apply to recording and publishing details of transfers of value to healthcare professionals and organisations by companies marketing medicinal products or medical devices?

  • 23.

    Enforcers
    Describe the bodies involved in monitoring and ensuring compliance with advertising controls for medicinal products and medical devices, distinguishing between any self-regulatory framework and control by the authorities.

  • 24.

    Sanctions
    What are the possible financial or other sanctions for breach of advertising and promotional controls for medicinal products or medical devices?

  • 25.

    Pricing
    What are the controls imposed on pricing of medicines and medical devices and reimbursement by national social security systems that are applicable to manufacturers, distributors and pharmacists?

  • 26.

    Off-label use
    May health professionals prescribe or use products for ‘off-label’ indications? May pharmaceutical companies draw health professionals’ attention to potential off-label uses?

  • 27.

    Unlicensed products
    What rules apply to the manufacture and importation and supply to healthcare providers of unlicensed medicines or medical devices?

  • 28.

    Compassionate use
    What rules apply to the establishment of compassionate use programmes for unlicensed products?

  • 29.

    Regulation
    Are there special rules governing the dispensing or sale of particular types of medicinal products or medical devices?

  • 30.

    Online supply
    What laws and guidelines govern online dispensing, sale and supply of medicinal products and medical devices?

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Lee & Ko has become one of Korea’s premier full-service law firms, widely recognised for its leadership and outstanding success in every area of legal practice. As has been confirmed in numerous reviews conducted by Korea’s major media outlets, as well as ratings produced by international law firm rating services, Lee & Ko enjoys one of the highest levels of client satisfaction and a particularly excellent reputation for the quality of the firm’s legal services.

View more information about Lee & Ko


Seoul
Hanjin Building
63 Namdaemun-ro, Jung-gu
04532
Seoul
Korea
T: +82 2 772 4000
F: +82 2 772 4001/2


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