Law of Ukraine

“On Ukraine’s Accession to the Convention on the Elaboration of a European Pharmacopoeia, with Amendments According to the Protocol Thereto”

Date of entry into force:
November 19, 2012

The Convention on the Elaboration of a European Pharmacopoeia (hereinafter referred to as “Convention”) was signed in Strasbourg on July 22, 1964.

The Law envisages Ukraine’s accession to the Convention.

According to Article 1 of the Convention, the Contracting Parties undertake:
  • progressively to elaborate a Pharmacopoeia which shall be common to the countries concerned and which shall be entitled "European Pharmacopoeia";
  • to take the necessary measures to ensure that the monographs which will be adopted by virtue of Articles 6 and 7 of the Convention and which will constitute the European Pharmacopoeia shall become the official standards applicable within their respective countries.

Article 2 of the Convention establishes that the elaboration of the European Pharmacopoeia shall be undertaken by:
  • the Public Health Committee whose activities are carried on within the framework of the Council of Europe (hereinafter referred to as “the Public Health Committee”);
  • a European Pharmacopoeia Commission established by the Public Health Committee for this purpose (hereinafter referred to as “the Commission”).

The Public Health Committee shall be composed of delegations appointed by the Contracting Parties (Article 3 of the Convention).

The functions of the Public Health Committee are determined in Article 4 of the Convention.

The Commission shall be composed of delegations appointed by the Contracting Parties. Each delegation shall consist of not more than three members chosen for their competence in matters within the functions of the Commission. Each Contracting Party may appoint the same number of alternates similarly competent. The Commission shall elect a Chairman from among its members by secret ballot, by a two-thirds majority of the votes of the delegations. The term of office of the Chairman and the conditions governing his re-election shall be laid down in the Rules of Procedure of the Commission. While he holds office, the Chairman shall not be a member of any delegation (Article 5 of the Convention).

According to Article 6 of the Convention, the functions of the Commission shall be:
  • to determine the general principles applicable to the elaboration of the European Pharmacopoeia;
  • to decide upon methods of analysis for that purpose;
  • to arrange for the preparation of and to adopt monographs to be included in the European Pharmacopoeia; and
  • to recommend the fixing of the time limits within which its decisions of a technical character relating to the European Pharmacopoeia shall be implemented within the territories of the Contracting Parties.

The procedure for decisions of the Commissions is determined by Article 7 of the Convention.

The Commission shall hold its meetings at Strasbourg, the seat of the Council of Europe. It shall be convened by its Chairman and meet as often as necessary, but at least twice a year. It shall meet in private; the working languages shall be the official languages of the Council of Europe.  The Public Health Committee may appoint an observer to attend meetings of the Commission (Article 8 of the Convention).

According to Article 9 of the Convention, the Commission shall have a secretariat, the head and the technical staff of which shall be appointed by the Secretary General of the Council of Europe on the advice of the Commission and in conformity with the Administrative Regulations of the Council of Europe staff. The other members of the secretariat shall be appointed by the Secretary General in consultation with the head of the Commission's secretariat.

The expenses of the secretariat of the Commission and all other common expenses incurred in the execution of the Convention shall be borne by the Contracting Parties (Article 10 of the Convention).
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