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    Changes in the submission and approval of mock-ups of veterinary medicinal products

    30.12.2019
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    As of 2nd of January, 2020 the mock-ups of the outer and immediate packaging of veterinary medicinal products will not be approved and have to be submitted (as PDF files) by the marketing authorisation holder to the State Agency of Medicines for information only:

     before commercialisation of the medicinal product:
    - after approval of any variation affecting the labelling text
    - in case of any changes in design (change in colours, location of text or adding text in different languages).

    Mock-ups have to be sent to documentation@ravimiamet.ee

    Mock-ups will not be approved.

    MA holders are responsible for the correct implementation of the agreed labelling text in the mock-ups, in line with the relevant legislation and guidelines.

    In case of any questions please contact labelling@ravimiamet.ee or documentation@ravimiamet.ee