Verdrag inzake de samenstelling van een Europese farmacopee

The Contracting Parties undertake:
(a) progressively to elaborate a Pharmacopoeia which shall be common to the countries concerned and which shall be entitled “European Pharmacopoeia”;
(b) to take the necessary measures to ensure that the monographs which will be adopted by virtue of Articles 6 and 7 of the present Convention and which will constitute the European Pharmacopoeia shall become the official standards applicable within their respective countries.

The elaboration of the European Pharmacopoeia shall be undertaken by:
(a) The Public Health Committee whose activities are carried on within the framework of the Council of Europe, in accordance with Resolution (59) 23 mentioned in the Preamble to the present Convention, hereinafter referred to as “the Public Health Committee”;
(b) A European Pharmacopoeia Commission established by the Public Health Committee for this purpose, hereinafter referred to as “the Commission”.

For the purposes of the present Convention, the Public Health Committee shall be composed of delegations appointed by the Contracting Parties.

1. The Public Health Committee shall exercise a general oversight over the activities of the Commission and for this purpose the Commission shall submit a report on each of its sessions to the Public Health Committee.
2. All decisions taken by the Commission, other than those of a technical or procedural character, shall be subject to the approval of the Public Health Committee. If the Public Health Committee does not approve a decision or approves it only partially, the Committee shall refer it back to the Commission for further consideration.
3. The Public Health Committee, having regard to the recommendations of the Commission under Article 6 (d), shall fix the time limits within which decisions of a technical character relating to the European Pharmacopoeia shall be implemented within the territories of the Contracting Parties.

1. 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.
2. The Commission shall draw up its own Rules of Procedure.
3. 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.

Subject to the provisions of Article 4 of the present Convention, the functions of the Commission shall be:
(a) to determine the general principles applicable to the elaboration of the European Pharmacopoeia;
(b) to decide upon methods of analysis for that purpose;
(c) to arrange for the preparation of and to adopt monographs to be included in the European Pharmacopoeia; and
(d) 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.

1. Each of the national delegations shall be entitled to one vote.
2. On all technical matters, including the order in which the monographs referred to in Article 6 are to be prepared, decisions of the Commission shall be taken by a unanimous vote of national delegations casting votes and a majority of the national delegations entitled to sit on the Commission.
3. All other decisions of the Commission shall be taken by a three-quarters majority of the votes cast. For these decisions, from the time of entry into force of the Convention in respect of the European Economic Community, the latter's delegation shall vote in place of its member States' delegations. It shall have a number of votes equal to the number of its member States' delegations.
However, should a Contracting Party alone possess the required majority, the Contracting Parties undertake to renegotiate the voting modalities no sooner than five years after the entry into force of the Protocol, at the request of one of them addressed to the Secretary General of the Council of Europe.

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

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.

1. The expenses of the Secretariat of the Commission and all other common expenses incurred in the execution of this Convention shall be borne by the Contracting Parties in accordance with the provisions of paragraph 2 of this Article.
2. Pending the conclusion of a special arrangement agreed to by all Contracting Parties for this purpose, the financial administration of operations carried out under the present Convention shall be dealt with in accordance with the provisions of the Partial Agreement Budget in the social field relating to the activities covered by Resolution (59) 23 referred to in the Preamble to the present Convention.
3. The conditions of any financial participation by the European Economic Community shall be determined by agreement between the Contracting Parties.

1. The present Convention shall be ratified or accepted by the Signatory Governments. Instruments of ratification or acceptance shall be deposited with the Secretary-General of the Council of Europe.
2. The present Convention shall enter into force three months after the date of deposit of the eighth instrument of ratification or acceptance.

1. After the date of the entry into force of the present Convention, the Committee of Ministers of the Council of Europe, sitting with its membership limited to the Representatives of the Contracting Parties, may invite, on such conditions as it considers appropriate, any other Member State of the Council to accede to the present Convention.
2. After the expiry of six years from the said date, the Committee of Ministers may invite, on such conditions as it considers appropriate, European States not members of the Council of Europe to accede to the present Convention.
3. The European Economic Community may accede to the present Convention.
4. Accession shall be effected by depositing with the Secretary-General of the Council of Europe an instrument of accession, which shall take effect three months after the date of its deposit.

1. Any Government may, at the time of signature or when depositing its instrument of ratification, acceptance or accession, specify the territory or territories to which the present Convention shall apply.
2. Any Government may, when depositing its instrument of ratification, acceptance or accession or at any later date, by declaration addressed to the Secretary-General of the Council of Europe, extend the present Convention to any other territory or territories specified in the declaration and for whose international relations it is responsible or on whose behalf it is authorised to give undertakings.
3. Any declaration made in pursuance of the preceding paragraph may, in respect of any territory mentioned in such declaration, be withdrawn according to the procedure laid down in Article 14 of the present Convention.
4. Paragraphs 1, 2 and 3 above shall apply mutatis mutandis to the European Economic Community.

1. The present Convention shall remain in force indefinitely.
2. Any Contracting Party may, as far as it is concerned, denounce the present Convention by means of a notification addressed to the Secretary-General of the Council of Europe.
3. Such denunciation shall take effect six months after the date of receipt by the Secretary-General of such notification.

The Secretary-General of the Council of Europe shall notify Contracting States of:
(a) any signature;
(b) the deposit of any instrument of ratification, acceptance or accession;
(c) the date of entry into force of the present Convention in accordance with Article 11;
(d) any declaration received in pursuance of the provisions of Article 13;
(e) any notification received in pursuance of the provisions of Article 14 and the date on which denunciation takes effect.

Supplementary agreements may be made concerning the detailed implementation of the provisions of the present Convention.

Pending the entry into force of the present Convention in accordance with the provisions of Article 11, the Signatory States agree, in order to avoid any delay in the implementation of the present Convention, to apply it provisionally from the date of signature, in conformity with their respective constitutional systems.