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    European Pharmacopoeia

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    Pharmacopoeia – it is a book of directions and requirements for the quality of medicines to guarantee the quality and safety of active pharmaceutical ingredients, excipients and medicinal products.

    The first and the last Estonian pharmacopoeia – Pharmacopoea Estonica – was published in 1937.

    Nowadays Estonia participates in the elaboration of European Pharmacopoeia according to the Convention on Elaboration of the European Pharmacopoiea – Convention No 50 of Council of Europe.

    • Estonia received an observer status at the European Pharmacopoeia Commission on 14 February 1997.
    • The Law for Joining the Convention on Elaboration of the European Pharmacopoiea, as amended by the Protocol of 16 November 1989 was approved by the Parliament on 24 October 2001.
    • The Law was promulgated by the President on 13 November 2001.

    ·        On 16 January 2002 Ambassador Ants Frosch, Permanent Representative of Estonia to the Council of Europe, handed the instrument of accession to the European Convention on the Elaboration of a European Pharmacopoeia [European Treaty Series n° 050], as amended by the Protocol of 16 November 1989, to Walter Schwimmer, Secretary General of the Organisation.

    This Convention entered into force for Estonia on 17 April 2002.

     

    The co-operation of the State Agency of Medicines with EDQM:

    ·        The representative of the State Agency of Medicines attends the Sessions of the European Pharmacopoeia Commission three times a year;

    ·        Experts of the State Agency of Medicines participate in the work of two groups of experts of the European Pharmacopoiea Commission.

    The laboratory of the State Agency of Medicines participate in OMCL Network since 1998. The analyst of the laboratory improved her training at the laboratory of EDQM in September-November 1998 as a scholar of Council of Europe.