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RS 0.812.32 European Agreement of 17 September 1974 on the Exchange of Reagents for the Determination of Tissue Groups (with Protocol and Annex)

Original Language Title: RS 0.812.32 Accord européen du 17 septembre 1974 sur l’échange de réactifs pour la détermination des groupes tissulaires (avec protocole et annexe)

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0.812.32

Original text

European agreement on the exchange of reagents for the determination of tissue groups

Conclu in Strasbourg on 17 September 1974

Approved by the Federal Assembly on September 15, 1975 1

Instrument of ratification deposited by Switzerland on 21 November 1975

Entered into force for Switzerland on 23 April 1977

(State 15 August 2006)

The States Parties to this Agreement, members of the Council of Europe,

Considering that reagents for the determination of tissue groups are available only in limited quantities;

Believing that it is highly desirable that, in a spirit of European solidarity, Member States should lend themselves to mutual assistance with a view to the provision of such reagents should the need arise;

Considering that mutual assistance is only possible if the properties and use of these reagents for the determination of tissue 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,

Have agreed as follows:

Art. 1

For the purposes of this Agreement, the term "tissue group determination reagents" means all reagents for the determination of tissue groups of human, animal, plant or other origin.

2. The provisions of s. 2 to 6 of this Agreement also apply to known antigenic composition cells used for the study of the reagents in question.

Art. 2

The Contracting Parties undertake, provided that they have sufficient reserves for their own needs, to make the reagents for the determination of the tissue groups available to other Parties who need them, without any further Compensation that 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

The reagents for the determination of tissue groups shall be made available to the other Contracting Parties under the conditions that they will not give rise to any benefit and shall be used solely for medical and scientific purposes, Non-commercial, and may only be delivered to the laboratories designated by the governments concerned in accordance with Art. 6 of this Agreement.

Art. 4

The Contracting Parties shall ensure compliance with the provisions as defined in the Protocol 1 To this Agreement.

2. They shall also comply with the rules to which they have acceded in the field of international standardisation in this field.

3. Any shipment of reagents for the determination of tissue groups shall be accompanied by a certificate attesting 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.


1 See below

Art. 5

1. The Contracting Parties shall take all necessary measures to exempt from all import rights the reagents for the determination of tissue groups made available to them by the other Parties.

2. They shall 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 the list of national and/or regional reference laboratories entitled to establish the certificate provided for in Art. 4 of this Agreement and to distribute the imported tissue grouping reagents.

Art. 7

1. This Agreement shall be open for signature by the member States of the Council of Europe which may become Parties to this Agreement by:

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

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

Art. 8

1. This Agreement shall enter into force one month after the date on which three member States of the Council have become Parties to the Agreement, in accordance with the provisions of Art. 7.

2. For any Member State which subsequently signs it without reservation as to ratification or acceptance or ratifies or accepts it, the Agreement shall enter into force one month after the date of signature or deposit of the instrument of ratification or Of acceptance.

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 it.

2. Accession shall be effected by the deposit, by the Secretary General of the Council of Europe, of an instrument of accession which shall take effect one month after the date of its deposit.

Art. 10

(1) Any Contracting Party may, at the time of signature or at the time of deposit of its instrument of ratification, acceptance or accession, designate the territory or territories to which this Agreement shall apply.

2. Any Contracting Party may, at the time of the deposit of its instrument of ratification, acceptance or accession or at any other time thereafter, extend the application of this Agreement by declaration addressed to the Secretary General of the Council of Europe, in any other territory designated in the declaration for which it is responsible for international relations or for which it is entitled to stipulate.

(3) Any declaration made under the preceding paragraph may be withdrawn, in respect of any territory designated in that declaration, under the conditions laid down in Art. 11 of this Agreement.

Art. 11

1. Any Contracting Party may, as far as it is concerned, denounce this Agreement by sending a notification to the Secretary General of the Council of Europe.

The denunciation shall take effect six months after the date of receipt of the notification by the Secretary General.

Art. 12

The Secretary General of the Council of Europe shall notify the member States of the Council and any State which has acceded to this Agreement:

A.
Any signature without reservation of ratification or acceptance;
B.
Any signature with reservation of ratification or acceptance;
C.
The deposit of any instrument of ratification, acceptance or accession;
D.
Any date of entry into force of this Agreement pursuant to the provisions of Art. 8;
E.
Any statement received pursuant to the provisions of s. 2 and 3 of Art. 10;
F.
Any notification received pursuant to the provisions of Art. 11, and the date on which the denunciation takes effect;
G.
Any amendment or supplement to the Protocol and its Annex under s. 4 of Art. 4 of this Agreement.

In witness whereof, The undersigned, duly authorized to that effect, have signed this Agreement.

Done at Strasbourg, on 17 September 1974, 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 of the Council of Europe shall transmit certified copies to each of the signatory and acceding States.

(Suivent signatures)

Protocol to the Agreement

General provisions

1. Speciality

2. Activity

3. Conservation

4. Stability and Expiration Date

5. Preparation and Volume by Sample

6. Record Results and Samples

7. Shipping

8. Tags, records, and certificates

Two labels, printed one in English and the other in French in black on white paper, will be fixed on each final container; they will contain the following information:

A.
Name and address of the producer;
B.
The name of the reagent as it appears in the title of the specification;
C.
The name and quantity of antiseptic and/or antibiotic, or the absence of these substances;
D.
The dose or, if the reagent is dehydrated, the dose and composition of the fluid required for its reconstitution;
E.
The expiration date;
F.
Lot number;
G.
Storage conditions;
H.
The results of the HB-Ag test.

In addition, these labels or labels on the cardboard containing several final containers, or the package insert, will contain the following information:

A.
The full name and address of the producer;
B.
The name of the reagent as it appears in the title of the specification;
C.
The dose or, if the reagent is dehydrated, the dose and composition of the fluid required for its reconstitution;
D.
The date of the last activity test;
E.
Expiration date (if applicable);
F.
Lot number;
G.
An appropriate description of the mode of use recommended by the producer;
H.
Storage conditions for non-open light bulbs and precautions to be taken after opening;
I.
The exact composition, including, if applicable, antiseptics and/or antibiotics;
J.
The fact that the product contains or does not contain materials of human origin.

Each shipment must be accompanied by a certificate in accordance with the provisions of s. 4 of the Agreement and of the Annex to this Protocol. Examples of labels and notices are attached to this Protocol.


Label Example

Council of Europe

European agreement on the exchange of reagents for the determination of tissue groups

1.
Name and address of producer
2.
Reactive for tissue anti-HL-A
3.
1 mL or Reconstitute with 1 mL distilled water
4.
Last Activity Control Date
5.
Expiration date
6.
Lot Number
7.
Technique to be used: NIH lymphocytotoxicity
8.
Keep to - ... (temp., etc.)
9.
Composition
10.
The Reagent continent of human serum

This label will be placed on the package containing several final containers.


Status August 15, 2006

Example of Notice

Council of Europe

European agreement on the exchange of reagents for the determination of tissue groups

1.
National Tissue Group Reference Laboratory, 1 Main Street, Metropolis, Westland
2.
Reactive for tissue anti-HL-A I
3.
N 3 Na 0.1 g % solution added
4.
1 mL or Reconstitute with 1 mL distilled water
5.
Expiration date of December 5, 1975
6.
Lot Number not 7257
7.
To be kept at -70 ° C
8.
Test result to detect HB-Ag: negative

This leaflet will be fixed on each final container.


Status August 15, 2006

Annex to the Protocol

Council of Europe

European agreement on the exchange of reagents for the determination of tissue groups

Certificate

(Art. 4)

Do Not Detach From Sending

19

(location) (date)

Number of Packages

The undersigned states that the specified shipment on the margin

Prepared under the responsibility of

Designation

N O Of batches

Organization referred to in s. 6 of the Agreement conforms to specifications

Of the Protocol to the Agreement and may be issued immediately

To recipient (name and location)

(stamp) (signature) (title)


Status August 15, 2006

Scope of application on 21 June 2006 2

States Parties

Ratification Signature without reservation of ratification (If)

Entry into force

Belgium

13 September

1979

14 October

1979

Cyprus

10 May

1976

April 23

1977

European Union

22 November

1977 Si

22 November

1977

Denmark

July 5

1978

August 6

1978

Finland

22 December

1994

23 January

1995

France

22 March

1977

April 23

1977

Greece

11 September

1987

12 October

1987

Ireland

January 18

1984 If

19 February

1984

Italy

15 June

1983

July 16

1983

Liechtenstein

27 January

1983

28 February

1983

Luxembourg

12 April

1978

13 May

1978

Netherlands *

12 April

1978

13 May

1978

United Kingdom

February 8

1979 If

March 9

1979

Guernsey

6 May

1980

6 May

1980

Isle of Man

6 May

1980

6 May

1980

Jersey

6 May

1980

6 May

1980

Slovakia

21 January

1999 If

22 February

1999

Slovenia

4 October

2000

5 November

2000

Switzerland

21 November

1975

April 23

1977

Turkey

1 Er December

2004

2 January

2005

*

Reservations and declarations, see below.

Statement

Netherlands

The agreement is applicable to the Kingdom of Europe.


RO 1977 1247; FF 1974 II 1360


1 Art. 1 Er Al. 1 of the AF of 15. 1975 (RO 1975 2239)
2 A version of the updated scope of application is published on the DFAE website (www.dfae.admin.ch/traites).


Status August 15, 2006