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Document 01994A0625(01)-19640722
CONVENTION ON THE ELABORATION OF A EUROPEAN PHARMACOPOEIA
Consolidated text: CONVENTION ON THE ELABORATION OF A EUROPEAN PHARMACOPOEIA
CONVENTION ON THE ELABORATION OF A EUROPEAN PHARMACOPOEIA
ELI: http://data.europa.eu/eli/convention/1994/358/1964-07-22
This consolidated text may not include the following amendments:
Amending act | Amendment type | Subdivision concerned | Date of effect |
---|---|---|---|
21994A0625(02) | Modified by | article 10 paragraph 3 Text | 01/11/1992 |
21994A0625(02) | Modified by | article 5 paragraph 3 Text | 01/11/1992 |
21994A0625(02) | Modified by | article 12 paragraph 3 | 01/11/1992 |
21994A0625(02) | Modified by | article 3 Text | 01/11/1992 |
21994A0625(02) | Modified by | article 5 paragraph 1 Text | 01/11/1992 |
21994A0625(02) | Modified by | article 13 paragraph 4 | 01/11/1992 |
21994A0625(02) | Modified by | article 7 Text | 01/11/1992 |
01994A0625(01) — EN — 22.07.1964 — 000.001
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CONVENTION ON THE ELABORATION OF A EUROPEAN PHARMACOPOEIA (OJ L 158 25.6.1994, p. 19) |
Amended by:
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PROTOCOL TO THE CONVENTION ON THE ELABORATION OF A EUROPEAN PHARMACOPOEIA |
L 158 |
22 |
25.6.1994 |
CONVENTION ON THE ELABORATION OF A EUROPEAN PHARMACOPOEIA
THE GOVERNMENTS OF THE KINGDOM OF BELGIUM, THE FRENCH REPUBLIC, THE FEDERAL REPUBLIC OF GERMANY, THE ITALIAN REPUBLIC, THE GRAND DUCHY OF LUXEMBOURG, THE KINGDOM OF THE NETHERLANDS, THE SWISS CONFEDERATION AND THE UNITED KINGDOM OF GREAT BRITAIN AND NORTHERN IRELAND,
Considering that the Parties to the Brussels Treaty of 17 March 1948, as amended on 23 October 1954, resolved to strengthen the social ties by which they are united and to make every effort in common, both by direct consultation and in specialized Agencies, to raise the standard of living of their peoples and promote the harmonious development of social services in their respective countries;
Considering that the social activities governed by the Brussels Treaty and carried on, until 1959, under the auspices of the Brussels Treaty Organization and the Western European Union are now conducted within the framework of the Community of Europe, in accordance with the decision taken on 21 October 1959 by the Council of Western European Union and with resolution (59) 23 adopted on 16 November 1959 by the Committee of Ministers of the Council of Europe;
Considering that the Swiss Confederation has participated since 6 May 1964 in activities in the field of public health carried on under the aforesaid resolution;
Considering that the aim of the Council of Europe is the achievement of greater unity between its Members in order to promote, inter alia, economic and social progress by the conclusion of agreements and by common action in economic, social, cultural, scientific, legal and administrative matters;
Considering that, so far as possible, they have endeavoured to promote progress both in the social field and in the related field of public health and that they have undertaken the harmonization of their national laws in pursuance of the aforementioned provisions;
Considering that such measures are now more than ever necessary in respect of the manufacture, circulation and distribution of medicines in Europe;
Convinced that it is desirable and necessary to harmonize specifications for medicinal substances which, in their original state or in the form of pharmaceutical preparations, are of general interests and importance to the peoples of Europe;
Convinced of the need to hasten the drawing up of specifications for the growing number of new medicinal substances appearing on the market;
Considering that this aim can best be achieved by the progressive establishment of a common pharmacopoeia for the European countries concerned,
HAVE AGREED AS FOLLOWS:
Article 1
Elaboration of a European Pharmacopoeia
The Contracting Parties undertake:
progressively to elaborate a Pharmacopoeia which shall be common to the countries concerned and which shall be entitled ‘European Pharmacopeia’;
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.
Article 2
Organs concerned with the elaboration of the European Pharmacopoeia
The elaboration of the European Pharmacopoeia shall be undertaken by:
The Public Health Commission 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’;
A European Pharmacopoeia Commission established by the Public Health Committee for this purpose, hereinafter referred to as ‘the Commission’.
Article 3
Composition of the Public Health Committee
For the purposes of the present Convention, the Public Health Committee shall be composed of ►M1 delegations ◄ appointed by the Contracting Parties.
Article 4
Functions of the Public Health Committee
Article 5
Membership of the Commission
Article 6
Functions of the Commission
Subject to the provisions of Article 4 of the present convention, the functions of the Commission shall be:
co-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 in the Contracting Parties.
Article 7
Decisions of the Commission
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.
Article 8
Seat and meetings of the Commission
Article 9
Secretariat 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.
Article 10
Finances
Article 11
Entry into force
Article 12
Accessions
Article 13
Territorial Application
Article 14
Duration
Article 15
Notifications
The Secretary-General of the Council of Europe shall notify Contracting States of:
any signature;
the deposit of any instrument of ratification, acceptance or accession;
the date of entry into force of the present Convention in accordance with Article 11;
any declaration received in pursuance of the provisions of Article 13;
any notification received in pursuance of the provisions of Article 14 and the date on which denunciation takes effect
Article 16
Supplementary Agreements
Supplementary agreements may be made concerning the detailed implementation of the provisions of the present Convention.
Article 17
Provisional Application
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.
In witness whereof the undersigned, being duly authorized thereto, have signed the present Convention.
Done at Strasbourg, this 22nd day of July 1964 in English and French, both texts being equally authoritative in a single copy which shall remain deposited in the archives of the Council of Europe. The Secretary-General shall send certified copies to each of the Signatory and acceding States.