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    Submission of Direct Healthcare Professional Communication texts for approval

    19.05.2014
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    General requirements
    Before the dissemination of DHPC the Marketing Authorisation Holder (MAH) shall have the DHPC text and communication plan approved by the State Agency of Medicines (according to article 4§ 3 of Regulation of the Ministry of Social Affairs no 26).

    If the safety information concerns a medicinal product of more than one MAH, the relevant MAHs shall draft the DHPC text together.
    When drafting a DHPC, the guidance provided in GVP module XV (Safety Communication) and the template published on EMA website should be followed:
    http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/01/WC500137665.pdf

    Submission of DHPC to SAM
    DHPC must be sent to e-mail pharmacovig@ravimiamet.ee

    To guarantee fast and smooth process
    - On the e-mail Subject line MAH should write “Name of the medicinal product, active substance”, “DHPC”.
    - In the letter MAH should clarify what are the grounds of drafting /submission of the DHPC - either request of the EMA or EU Member State (i.e in case of MRP or DC products)
    - DHPC as word file in Estonian and English

    In addition the following must be submitted:
    - Communication plan (to whom DHPC is meant, distribution plan, timetable)
    - Estonian speaking contact (according to article 4§ 4 of Regulation of the Ministry of Social Affairs no 26).

    Other important requirements
    DHPC must not contain advertising elements (no product logo or unrelated pictures)
    DHPC must include the following text:
    „Kõigist ilmnenud kõrvaltoimetest tuleb teavitada Ravimiametit või müügiloa hoidjat.
    Ravimiamet: kasutage ravimi kõrvaltoimest teatamise vormi (leitav veebiaadressilt: http://www.ravimiamet.ee).
    <name of the MAH> : <contact details>.”

    Timelines of review/approval of the DHPC
    The State Agency of Medicines shall inform the MAH of the approval of the text and plan of distribution of the DHPC, a need for introducing changes or refusal from approval within five working days from the date of receiving the DHPC text and distribution plan or according to the EMA timetable.

    Publication of the DHPC on SAM website
    The MAH must notify the date of dissemination (in case DHPC is disseminated via e-mail, pharmacovig@ravimiamet.ee must be added to the list of recipients). State Agency of Medicines will publish the DHPC on our website: http://www.ravimiamet.ee/ohutusalased-teabekirjad