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    Supervision over handling of medicinal products

    27.10.2010
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    State Agency of Medicines (SAM) supervises all licenced sites (manufacturers, wholesalers, pharmacies) through regular inspections.
    The same inspection principles apply to human and veterinary medicinal products.

    Case-by-case SAM inspects other institutions handling medicines e.g. health care establishments. Co-operation is made with the Health Board and the Veterinary and Food Board.

    Inspection references are: national primary and secondary legislation (all activities involving handling of medicinal products), Eudralex Volume 4 Good Manufacturing Practice (manufacture).
    Translation into English is available for the national regulation on wholesale distribution, which includes the requirements of Good Distribution Practice.

    Conditions and Procedure for Wholesale Distribution of Medicinal Products1

    SAM co-operates with institutions under the Tax and Customs Board and the Police and Border Guard Board to contribute into prevention of illegal activities and counterfeits.