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    Post-authorisation procedures support

    Obtaining Marketing Authorisation (MA) is undoubtedly a milestone, but it is worth remembering that post-authorisation aspects are an important stage in the product life cycle, and they need to be supervised properly. For example, failure of the MAH to submit the renewal application by the appropriate deadline may lead to a complete loss of the MA. SciencePharma offers a wide range of post-authorisation services helping to keep MA in proper.

    Scope of post-authorisation services includes:

    • Product lifecycle management covering all types of variations management, line extension application, sunset clause exemption, annual fees, renewals and withdrawals applications
    • OTC switches comprehensive support – we have experience in Rx->OTC switches performed in different EU countries, by different EU CA
    • MAH transfers application and support, not only in Poland but also in different EU countries
    • Promotional materials review
    • Medical information service.

    How can we help You?

      Please be advised that the administrator of personal data entered in the above form is SciencePharma Sp. z o.o. with its registered office in Warsaw, Chełmska 30/34. These data are processed in order to receive incoming correspondence and respond to it. Providing personal data is voluntary, but necessary to send the form. Each person has the right to access their data and correct it.

      You can read the details on the protection of personal data here.