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    Amendments in regulations of the Minister of Social Affairs

    28.04.2011
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    The amendments in regulations of the Minister of Social Affairs of 13 April 2005 No. 58 „The Conditions and Procedure for Handling and Labelling of Packages of Herbal Substances and a List of Herbal Substances“ and No. 59 „The Conditions and Procedure for Classifying a Substance or Product as a Medicinal Product“ have been entered into force.

    The regulation of the Minister of Social Affairs of 13 April 2005 No. 59 „The Conditions and Procedure for Classifying a Substance or Product as a Medicinal Product“ has been amended substantially and the conditions and procedure have amended in accordance with the principles laid down by the European Court of Justice.

    As so far the State Agency of Medicines determined the products as medicinal product taking into consideration mainly the composition of the product, now according to the amendment of the regulation the products and substances will be determined on a case-by-case basis taking into account all specific characteristics of the product, in particular the composition, pharmacological properties to the extent to which they can be established in the present state of scientific knowledge, the manner it is used, the extent of its distribution, its familiarity to the consumers and the risk its use may entail.

    The List of Herbal Substances is repealed as the State Agency of Medicines should not classify the products only by composition but all facts of the product should be taken into account. For the aim of better information the State Agency of Medicines is publishing the list of herbs and substances containing in products and have defined as medicinal products on the web-site. The list will be updated on a regular basis.

    Due to repealing of the List of Herbal Substances the amendments in the regulation of the Minister of Social Affairs of 13 April 2005 No. 58 “The Conditions and Procedure for Handling and Labelling of Packages of Herbal Substances and a List of Herbal Substances” have been made.

    The list of herbs and substances containing in products determined as medicinal products.

    For further information please contact the e-mail address info@ravimiamet.ee