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RS 0.812.31 European Agreement of 14 May 1962 on the exchange of reagents for the determination of blood groups

Original Language Title: RS 0.812.31 Accord européen du 14 mai 1962 relatif à l’échange des réactifs pour la détermination des groupes sanguins

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0.812.31

Original text

European Agreement on the Exchange of Reagents for Determination

Blood groups

Conclu in Strasbourg on 14 May 1962

Approved by the Federal Assembly on September 20, 1965 1

Instruments of ratification deposited by Switzerland on 29 November 1965

Entered into force for Switzerland on 30 December 1965

(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:

Art. 1

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 This declaration may be withdrawn at any time by notification addressed to the Secretary General of the Council of Europe.

Art. 2

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.

Art. 3

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,

Art. 4

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.

Art. 5

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.

Art. 6

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 .

1 RS 0.812.161

Art. 7

This Agreement shall be open for signature by the Members of the Council of Europe which may become Parties by:

A.
Signature without reservation of ratification or approval, or
B.
Signature subject to ratification or approval followed by ratification or approval.

Instruments of ratification or approval shall be deposited with the Secretary General of the Council of Europe.

Art. 8

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.

Art.

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.

Art. 10

The Secretary General of the Council of Europe shall notify the Members of the Council and the acceding States:

A.
The date of entry into force of this Agreement and the names of the Members having signed it without reservation of ratification or approval or having ratified or approved it;
B.
The deposit of any instrument of accession made pursuant to the provisions of Art. 9;
C.
Any declaration and notification received pursuant to the provisions of the second paragraph of Art. 1;
D.
Any notification received pursuant to the provisions of Art. 11 and the date on which it will take effect;
E.
Any amendment to the Protocol and its annex under the fourth paragraph of Art. 4.
Art. 11

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)

Protocol to the Agreement

General provisions

1. Speciality

2. Power

3. International Standards and International Units

4. Stability and Expiration Date

5. Retention

6. Coloring

7. Distribution and Quantity

8. Records and Samples

9. Classification of Reagents

10. Labelling, Notice and Certificate

Special provisions

A. Human-derived Reagents for Determining Blood Groups

A. Human Serums for blood grouping A. B. 0.

B. Human serum for blood grouping Rh

B. Non-Human Reagents

A. Animal Sérums

B. Reagents of plant origin

(i) Reactive anti-A for blood grouping (plant)

The anti-A reagent is extracted from the seeds or any other part of a plant suitable for that purpose and then subjected, if necessary, to a purification process. The anti-A reagent agglutine human red cells containing agglutinogens A, i.e. those of groups A and AB, including subgroups A 1 , A 2 , A 1 B and A 2 B, and did not respond to human red blood cells devoid of the agglutinogens A, that is, those in groups 0 and B.
Power
Titrage
An anti-A reagent must be titrated separately on suspensions of A 1 A 2 And A 2 B parallel to the reconstituted but undiluted international prover of serum for anti-A blood grouping, or equivalent reference preparation 6 .
The power of the reagent shall not, under any circumstances, be less than 64 International Units per ml.
Determination Avidity
After mixing, on a blade, an anti-A reagent with an equal volume of a suspension at 5 %-10 % of A 1 , A 2 And A 2 B, the agglutination of each suspension shall appear before the double of the time necessary for the agglutination, under the same conditions, obtained by means of the reconstituted but undiluted international standard of the serum for grouping Anti-A blood or a prover of the same avidity.

(ii) Anti-B Reactive for blood grouping (plant)

The anti-B reagent is extracted from the appropriate part of a plant suitable for this use and subjected, then, if necessary, to a purification process. The anti-B reagent agglutine human red blood cells containing agglutinogen B, that is, those of groups B and AB, and did not agglutine the human red blood cells devoid of agglutinogen B, that is, those in groups 0 and A.
Power
Titrage
An anti-B reagent must be titrated on a B-cell suspension parallel to the reconstituted but undiluted international standard of serum for anti-B blood grouping or equivalent reference preparation 7 The power of the reagent shall not be less than 64 International Units per ml.
Determination of greed
After mixing, on a blade, the anti-B reagent with an equal volume of a suspension at 5 %-10 % of B cells, the agglutination must appear before the double of the time necessary for the agglutination, under the same conditions, obtained by means of the An international reconstituted but undiluted standard for the anti-B blood grouping or a standard of the same greed.

Appendices to the Protocol

Label examples

Council of Europe

European Agreement on the Exchange of Reagents for the Determination of Blood Groups

A. Liquid serum

1.
Laboratory X, Amsterdam
2.
Serum anti-A (human)
3.
N 3 Na 0.1 %
4.
5 ml
5.
7 September 1965
6.
N O 1 2 3 4

B. Dried serum

1.
Laboratory X, Amsterdam
2.
Serum anti-B (animal)
3.
Mersalate 0.1 %
4.
Reconstitute with 5 mL of distilled water
5.
31 December 1968
6.
N O 4231

Example of a record

Council of Europe

European Agreement on the Exchange of Reagents for the Determination of Blood Groups

1.
Central Blood Transfusion Laboratory, 1 Main Street, Metropolis, Westland;
2.
Anti-E (anti-rh ' ') (human);
3.
10 ml
4.
Date of last activity check: 30 May 1961;
5.
Expiration date: 30 May 1962;
6.
N O 5432;
7.
The red cells to be examined must be washed one or more times with a saline solution of 0.9 %. A suspension of about 3 % is then prepared by mixing a volume or a drop of globular pellet with 30 volumes or drops of saline solution. With a little habit, the concentration of a suspension can be satisfactorily assessed to the naked eye.
A small drop of serum was deposited in a hemolysis tube (6 × 30 mm) using a Pasteur pipette. A small drop of red blood cell suspension is then added. (With a little habit, a considerable economy can be achieved by distributing serum and globular suspension using piped pipettes to 0.01 mL). The contents of the tube are mixed and incubated two hours at 37 ° C. The contents of the tube are then transported and carefully calibrated on a microscope slide. If the agglutination is not clearly visible to the naked eye, the blade is examined under the microscope to determine if the agglutination has occurred and determine its intensity;
8.
Keep at a temperature less than or equal to -20 °C. If the product is not used on the same day of opening, add 0.1 mL of N solution 3 Na to 10 %;
9.
Anti-E human serum (anti-rh ' '): 5 ml 30 % bovine Albumin: 5 ml
10.
This reagent contains a substance of human origin.
Status January 25, 2016

Annex to the Protocol

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

Designation

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)

(stamp) (signature) (title)

Status January 25, 2016

Scope of application January 25, 2016 8

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

Aruba

20 May

1965

21 June

1965

Curaçao

20 May

1965

21 June

1965

Caribbean (Bonaire, Sint Eustatius and Saba)

20 May

1965

21 June

1965

Sint Maarten

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.

Reservations and declarations

France

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.

Ireland

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.

Malta

Same statement as France.

Netherlands

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.

United Kingdom

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.

RO 1966 849; FF 1965 I 445

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. Image
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).

Status January 25, 2016