Medical Information and the Validation of Promotional Materials

Art 98 of Directive 2001/83 as amended require Holders of Marketing Authorisation for Medicinal Products to appoint a Responsible Person for Medical Information.

    Responsible Person for Medical Information Job Description

    • during development, provide advice on legal requirements and other recommendations applicable to Medicines Promotion
    • perform editorial checks of all written promotional materials; all elements must be scientifically correct, up-to-date, verifiable and non-misleading.
    • ensure that information about medicines provided to healthcare professionals and to the general public is in line with the approved product information and the Summary of Product Characteristics.
    • train marketing and sales representatives on the do's and dont's of medicines promotion.


    • medical information procedures.

    Audit of the Medical Information system consists of

    • compliance of procedures with applicable regulatory requirements
    • compliance of operating procedures with quality system requirements
    • implementation of the quality system and documental instructions.
    • processes for free sample distribution should meet all legal and procedural requirements
    • documentation of free medical sample distribution
    • staff qualifications, training records and documentation of experience

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