Key Benefits:
Original text
(State on 25 January 2016)
The signatory governments of the member states of the Council of Europe,
Whereas reagents for the determination of blood groups are available only in limited quantities;
Taking the view that it is highly desirable that, in a spirit of European solidarity, member countries lend themselves to mutual assistance in the provision of these reagents for the determination of blood groups, should the need arise;
Whereas mutual assistance is only possible if the properties and use of these reagents for the determination of blood groups are subject to rules established in common by the Member States and whether the importation of these reagents Benefits from the necessary facilities and exemptions;
Agreed to the following:
For the purposes of this Agreement, the terms "reactants for the determination of blood groups" shall designate all reagents for the determination of blood groups and the detection of blood incompatibilities of human, animal origin, Plant or other.
Any Contracting Party may, at the time of signature of this Agreement or the deposit of its instrument of ratification or approval or accession, by declaration addressed to the Secretary General of the Council of Europe, limit the application of the Agreement with reagents for the determination of blood groups of human origin. This declaration may be withdrawn at any time by notification addressed to the Secretary General of the Council of Europe.
The Contracting Parties undertake, provided that they have sufficient reserves for their own needs, to make the reagents for the determination of blood groups available to other Parties with an urgent need, without Other remuneration than is necessary for the reimbursement of the costs of collection, preparation and transport of such substances and, where applicable, the costs of the purchase thereof.
Reagents for the determination of blood groups shall be made available to the other Contracting Parties under the conditions that they will not give rise to any benefit, that they shall be used solely for medical purposes and that they shall not be Submitted to organizations designated by the governments concerned,
The Contracting Parties shall ensure compliance with the provisions as defined in the Protocol to this Agreement.
They will also comply with the rules to which they have acceded in the field of international standardisation in this field.
Any shipment of reagents for the determination of blood groups shall be accompanied by a certificate stating that it has been prepared in accordance with the specifications of the Protocol. The certificate will be prepared in accordance with the model set out in the annex to the Protocol.
The Protocol and its annex shall have the character of an administrative arrangement and may be amended or supplemented by the Governments of the Parties to this Agreement.
The Contracting Parties shall take all necessary measures to exempt from all import duties the reagents for the determination of blood groups made available to them by the other Parties.
They will also take all necessary measures to ensure, through the most direct route, the rapid delivery of these substances to the recipients referred to in Art. 3 of this Agreement.
The Contracting Parties shall, through the Secretary General of the Council of Europe, communicate a list of the bodies authorised to establish the certificate provided for in Art. 4 of this Agreement.
They will also provide a list of organizations authorized for the distribution of reagents for the determination of imported blood groups. These organizations will, to the greatest extent possible, be those covered by s. 6 of the European Agreement on the Exchange of Therapeutic Substances of Human Origin 1 .
This Agreement shall be open for signature by the Members of the Council of Europe which may become Parties by:
Instruments of ratification or approval shall be deposited with the Secretary General of the Council of Europe.
This Agreement shall enter into force one month after the date on which three Members of the Council, in accordance with the provisions of Art. 7, shall have signed the Agreement without reservation as to ratification or approval or have ratified or approved it.
The Agreement shall enter into force one month after the date of signature or deposit of the instrument of ratification or approval for any Member who subsequently signs it without reservation as to ratification or approval or ratification or approval.
After the entry into force of this Agreement, the Committee of Ministers of the Council of Europe may invite any non-member State of the Council to accede to this Agreement. Accession shall take effect one month after the date of deposit of the instrument of accession with the Secretary General of the Council of Europe.
The Secretary General of the Council of Europe shall notify the Members of the Council and the acceding States:
This Agreement shall remain in force without limitation.
Any Contracting Party may terminate, as far as it is concerned, the application of this Agreement by giving one year's notice to this effect to the Secretary General of the Council of Europe.
In witness whereof, The undersigned, duly authorized to that effect by their respective Governments, have signed this Agreement.
Done at Strasbourg, on 14 May 1962, in English and in French, both texts being equally authentic, in a single copy which shall be deposited in the archives of the Council of Europe. The Secretary General shall transmit certified copies to each of the signatory and acceding Governments.
(Suivent signatures)
(i) Reactive anti-A for blood grouping (plant)
(ii) Anti-B Reactive for blood grouping (plant)
Council of Europe
European Agreement on the Exchange of Reagents for the Determination of Blood Groups
A. Liquid serum
B. Dried serum
Council of Europe
European Agreement on the Exchange of Reagents for the Determination of Blood Groups
Council of Europe
European Agreement on the Exchange of Reagents for the Determination of Blood Groups
Certificate
(art. 4)
Do Not Detach From Sending
19
(location) (date)
Number of Packages |
The undersigned hereby declares that the consignment specified in margin prepared under the responsibility of |
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Designation |
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N O Of batches |
Organization referred to in s. 6 of the Agreement is in conformity with the specifications of the Protocol to the Agreement and may be issued immediately to the addressee (name and place) |
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(stamp) (signature) (title) |
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States Parties |
Ratification Accession (A) Signature without reservation of ratification (If) |
Entry into force |
||
Germany |
1 Er December |
1987 |
2 January |
1988 |
Belgium |
18 October |
1967 |
19 November |
1967 |
Cyprus |
23 September |
1969 |
24 October |
1969 |
Denmark |
13 September |
1962 Si |
14 October |
1962 |
Spain |
7 March |
1975 A |
April 8 |
1975 |
Finland |
22 December |
1994 |
23 January |
1995 |
France * |
5 February |
1964 |
21 January |
1964 |
Greece |
29 November |
1988 |
December 30 |
1988 |
Ireland * |
1 Er July |
1970 If |
2 August |
1970 |
Italy |
24 March |
1966 |
April 25 |
1966 |
Liechtenstein |
28 October |
1969 A |
29 November |
1969 |
Luxembourg |
23 January |
1968 |
24 February |
1968 |
Malta * |
28 February |
1967 |
March 29 |
1967 |
Norway |
14 May |
1962 Si |
14 October |
1962 |
Netherlands * |
20 May |
1965 |
21 June |
1965 |
|
20 May |
1965 |
21 June |
1965 |
|
20 May |
1965 |
21 June |
1965 |
|
20 May |
1965 |
21 June |
1965 |
|
20 May |
1965 |
21 June |
1965 |
United Kingdom * |
8 December |
1964 |
9 January |
1965 |
Slovakia |
28 November |
2003 |
29 December |
2003 |
Slovenia |
4 October |
2000 |
5 November |
2000 |
Sweden |
14 May |
1962 Si |
14 October |
1962 |
Switzerland |
29 November |
1965 |
December 30 |
1965 |
Turkey |
27 November |
1964 |
28 December |
1964 |
European Union |
30 March |
1987 Si |
1 Er April |
1987 |
* Reservations and declarations, see below. |
At the time of signature, the Government of France declares, in accordance with Article 1, to limit the application of the Agreement to reagents for the determination of blood groups of human origin.
At the time of signature, Ireland declared, in accordance with Art. 1 of the agreement, that the application of the agreement is limited to reagents for the determination of blood groups of human origin.
Same statement as France.
The Government of the Kingdom of the Netherlands reserves the right to extend the appli-cation of the Agreement with Protocol and Annexes to Suriname when the Government of that country expresses its wish.
Ratification of the Agreement is valid only for the United Kingdom and does not apply to territories for which the United Kingdom Government is responsible for international relations.
1 RO 1966 803
2 The potency of the reactants for the blood grouping of most specificities is expressed by the agglutination titre observed in a series of dilutions on a red cell suspension. The title indicates the dilution of the reagent used in the last mixture that gave rise to agglutination (visible under the microscope). The potency of blood grouping reagents, for which there are international standards (anti-A and anti-B, at present), may be expressed in International Units * on the basis of a titration of the unknown reagent compared to the International standard preparation or national substandard. International serum grouping serums are distributed in ampoules containing desiccated human serum. In the volume of 1 ml, the serum contains 256 U.I. per ml. They are provided free of charge by the International Laboratory for Biological Standards of the O. M.S., Statens Serum-Institute, Copenhagen. The following table shows an example of comparative titration of international anti-A (S) serum and an "unknown" anti-A reagent (U) with red blood cells A 1 And red blood cells A 2 B.
3 The "international standard" is of human origin; the equivalent standard preparation, if any, may be either of human origin or of animal origin.
4 The "international standard" is of human origin; the equivalent standard preparation, if any, may be either of human origin or of animal origin.
5 Coombs, R. R. A.; Mourant, A. E. and Race, R. R. (1945); Lancet , ii, 15 Coombs, R. R. A.; Mourant, A. E. and Race, Brit. J. exp. Path. 26.255.
6 The "international standard" is of human origin; the equivalent standard preparation that will be used, if any, may be either of human origin or of animal origin.
7 The "international standard" is of human origin; the equivalent standard preparation, if any, may be either of human origin or of animal origin.
8 RO 1966 849, 1969 1136, 1973 1783, 1983 259, 1987 1224, 1989 1172, 2003 3829, 2007 4219, 2016 509. A version of the updated scope of application is published on the DFAE website (www.dfae.admin.ch/traites).