Practice Areas

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  • Health Care Law

    Health Care Law Definition

    The health care industry is subject to strict regulations regarding development, authorization, manufacture, distribution, importation, and other activities such as post-marketing surveillance of medicinal products, medical devices, cosmetics, and food supplements. This is the reason why health care industries need specialized guidance and advice in order to carry out their activities.

    The Health Care Law practice accompanies the entire life of a medicinal product from its embryonic state until its death. Health Care Law services include, among others, guidance and advice on:

    Procedures for evaluating and granting marketing authorizations in Spain and the European Union;

    Specific characteristics of generics and hybrid medicinal products, biosimilar medicinal products, orphan medicinal products, advance therapy medicinal products, etc.

    • A wide range of agreements related to the pharmaceutical industry: license and distribution agreements, co-promotion agreements, manufacturing agreements, clinical trial agreements, etc.• Pricing and reimbursement;

    • Importation and exportation of medicinal products;

    • Pharmacovigilance and withdrawal of medicinal products from the market;

    • Review of promotional materials to health care professionals (HCPs) and/or to the general public;

    • Compliance of the health care industry's activity with industry regulations and legislation on events and hospitality, service agreements, donations, and grants;

    • Transparency and disclosure obligations regarding transfers of value from pharmaceutical companies to HCPs and/or health care organizations (HCOs).

    Similarly, the Health Care Law practice accompanies the entire life of medical devices: classification of medical devices, CE marking procedures, commercial agreements, pricing and reimbursement, compliance, importation and exportation, market surveillance and vigilance, promotional materials, etc.

    Finally, the Health Care Law practice provides advice on cosmetic products (safety, notification, advertising, and packaging and labeling requirements), as well as on food supplements (notification to the authorities, ingredients and labelling review, and nutrition and health claims checks).

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