Protocol to the European Agreement on the Exchange of Therapeutic Substances ... (21987A0207(02))
Protocol to the European Agreement on the Exchange of Therapeutic Substances of Human Origin
- PROTOCOL TO THE EUROPEAN AGREEMENT
- on the Exchange of Therapeutic Substances of Human Origin
- PART I
- GENERAL PROVISIONS
- A. LABELLING
- B. PACKING AND DISPATCH
- C. PRODUCTS AND APPARATUS
- D. FREEDOM FROM TOXICITY OF PLASTIC BLOOD TRANSFUSION EQUIPMENT
- PART II
- SPECIFIC PROVISIONS
- 1. WHOLE HUMAN BLOOD
- Blood group
- Storage
- Labelling
- 1a. HUMAN RED CELL CONCENTRATE
- Blood group and storage
- Labelling
- 2. DRIED HUMAN PLASMA
- Dried human plasma prepared from one or two donations of blood
- Dried human plasma prepared from pools of more than two donations
- Solubility in water
- Identification
- Loss of mass on drying
- Sterility
- Storage
- Labelling
- 3. HUMAN ALBUMIN AND HUMAN PLASMA PROTEIN FRACTION
- Solubility of the dried product
- Stability
- Identification
- Sodium content and sodium concentration
- Potassium concentration
- Acidity
- Loss of mass on drying
- Sterility
- Storage
- Labelling
- 4. HUMAN NORMAL IMMUNOGLOBULIN
- Identification
- Stability
- Acidity
- Sterility
- Storage
- Labelling
- 5. HUMAN SPECIFIC IMMUNOGLOBULINS
- Labelling
- 6. DRIED HUMAN FIBRINOGEN
- Solubility
- Identification
- Loss of mass on drying
- Sterility
- Storage
- Labelling
- 7. DRIED OR FROZEN HUMAN COAGULATION FACTOR VIII
- I.
- Requirements applying to donors
- II.
- Requirements applying to preparations
- Sterility and atoxicity
- Erythrocytes, leukocytes and platelets
- Solubility
- Stability
- Potency
- Identification
- Loss of mass on drying
- Storage
- III.
- Labelling
- 8. DRIED HUMAN COAGULATION FACTOR IX
- I.
- Requirements applying to donors
- II.
- Requirements applying to the concentrate
- Sterility and atoxicity
- Solubility
- Thromboplastin activity and absence of free thrombin
- Potency
- Yield and stability
- in vivo
- Identification
- Loss of mass on drying
- Storage
- III.
- Labelling
- ANNEXE I AU PROTOCOLE
- ANNEX I TO THE PROTOCOL
- CONSEIL DE L'EUROPE
- COUNCIL OF EUROPE
- ACCORD EUROPÉEN RELATIF À L'ÉCHANGE DE SUBSTANCES THÉRAPEUTIQUES D'ORIGINE HUMAINE
- EUROPEAN AGREEMENT ON THE EXCHANGE OF THERAPEUTIC SUBSTANCES OF HUMAN ORIGIN
- ANNEXE 2 AU PROTOCOLE
- ANNEX 2 TO THE PROTOCOL
- CONSEIL DE L'EUROPE
- COUNCIL OF EUROPE
- ACCORD EUROPÉEN RELATIF À L'ÉCHANGE DE SUBSTANCES THÉRAPEUTIQUES D'ORIGINE HUMAINE
- EUROPEAN AGREEMENT ON THE EXCHANGE OF THERAPEUTIC SUBSTANCES OF HUMAN ORIGIN
- ANNEXE 2
- bis
- AU PROTOCOLE
- ANNEX 2a TO THE PROTOCOL
- CONSEIL DE L'EUROPE
- COUNCIL OF EUROPE
- ACCORD EUROPÉEN RELATIF À L'ÉCHANGE DE SUBSTANCES THÉRAPEUTIQUES D'ORIGINE HUMAINE
- EUROPEAN AGREEMENT ON THE EXCHANGE OF THERAPEUTIC SUBSTANCES OF HUMAN ORIGIN
- ANNEXE 3 AU PROTOCOLE
- ANNEX 3 TO THE PROTOCOL
- CONSEIL DE L'EUROPE
- COUNCIL OF EUROPE
- ACCORD EUROPÉEN RELATIF À L'ÉCHANGE DE SUBSTANCES THÉRAPEUTIQUES D'ORIGINE HUMAINE
- EUROPEAN AGREEMENT ON THE EXCHANGE OF THERAPEUTIC SUBSTANCES OF HUMAN ORIGIN
- ANNEXE 4 AU PROTOCOLE
- ANNEX 4 TO THE PROTOCOL
- CONSEIL DE L'EUROPE
- COUNCIL OF EUROPE
- ACCORD EUROPÉEN RELATIF À L'ÉCHANGE DE SUBSTANCES THÉRAPEUTIQUES D'ORIGINE HUMAINE
- EUROPEAN AGREEMENT ON THE EXCHANGE OF THERAPEUTIC SUBSTANCES OF HUMAN ORIGIN
- ANNEXE 4 (suite 1)
- ANNEX 4 (continued 1)
- CONSEIL DE L'EUROPE
- COUNCIL OF EUROPE
- ACCORD EUROPÉEN RELATIF À L'ÉCHANGE DE SUBSTANCES THÉRAPEUTIQUES D'ORIGINE HUMAINE
- EUROPEAN AGREEMENT ON THE EXCHANGE OF THERAPEUTIC SUBSTANCES OF HUMAN ORIGIN
- ANNEXE 4 (suite 2)
- ANNEX 4 (continued 2)
- CONSEIL DE L'EUROPE
- COUNCIL OF EUROPE
- ACCORD EUROPÉEN RELATIF À L'ÉCHANGE DE SUBSTANCES THÉRAPEUTIQUES D'ORIGINE HUMAINE
- EUROPEAN AGREEMENT ON THE EXCHANGE OF THERAPEUTIC SUBSTANCES OF HUMAN ORIGIN
- ANNEXE 5 AU PROTOCOLE
- ANNEX 5 TO THE PROTOCOL
- CONSEIL DE L'EUROPE
- COUNCIL OF EUROPE
- ACCORD EUROPÉEN RELATIF À L'ÉCHANGE DE SUBSTANCES THÉRAPEUTIQUES D'ORIGINE HUMAINE
- EUROPEAN AGREEMENT ON THE EXCHANGE OF THERAPEUTIC SUBSTANCES OF HUMAN ORIGIN
- ANNEXE 6 AU PROTOCOLE
- ANNEX 6 TO THE PROTOCOL
- CONSEIL DE L'EUROPE
- COUNCIL OF EUROPE
- ACCORD EUROPÉEN RELATIF À L'ÉCHANGE DE SUBSTANCES THÉRAPEUTIQUES D'ORIGINE HUMAINE
- EUROPEAN AGREEMENT ON THE EXCHANGE OF THERAPEUTIC SUBSTANCES OF HUMAN ORIGIN
- ANNEXE 7 AU PROTOCOLE
- ANNEX 7 TO THE PROTOCOL
- CONSEIL DE L'EUROPE
- COUNCIL OF EUROPE
- ACCORD EUROPÉEN RELATIF À L'ÉCHANGE DE SUBSTANCES THÉRAPEUTIQUES D'ORIGINE HUMAINE
- EUROPEAN AGREEMENT ON THE EXCHANGE OF THERAPEUTIC SUBSTANCES OF HUMAN ORIGIN
- ANNEXE 8 AU PROTOCOLE
- ANNEX 8 TO THE PROTOCOL
- CONSEIL DE L'EUROPE
- COUNCIL OF EUROPE
- ACCORD EUROPÉEN RELATIF À L'ÉCHANGE DE SUBSTANCES THÉRAPEUTIQUES D'ORIGINE HUMAINE
- EUROPEAN AGREEMENT ON THE EXCHANGE OF THERAPEUTIC SUBSTANCES OF HUMAN ORIGIN
- ANNEXE 9 AU PROTOCOLE
- ANNEX 9 TO THE PROTOCOL
- CONSEIL DE L'EUROPE
- COUNCIL OF EUROPE
- ACCORD EUROPÉEN RELATIF À L'ÉCHANGE DE SUBSTANCES THÉRAPEUTIQUES D'ORIGINE HUMAINE
- EUROPEAN AGREEMENT ON THE EXCHANGE OF THERAPEUTIC SUBSTANCES OF HUMAN ORIGIN
- ANNEXE 10 AU PROTOCOLE
- ANNEX 10 TO THE PROTOCOL
- CONSEIL DE L'EUROPE
- COUNCIL OF EUROPE
- ACCORD EUROPÉEN RELATIF À L'ÉCHANGE DE SUBSTANCES THÉRAPEUTIQUES D'ORIGINE HUMAINE
- EUROPEAN AGREEMENT ON THE EXCHANGE OF THERAPEUTIC SUBSTANCES OF HUMAN ORIGIN
- ANNEX II TO THE PROTOCOL
- COUNCIL OF EUROPE
- EUROPEAN AGREEMENT ON THE EXCHANGE OF THERAPEUTIC SUBSTANCES OF HUMAN ORIGIN
- FREEDOM FROM TOXICITY OF PLASTIC BLOOD-TRANSFUSION EQUIPMENT
- I. CHEMICAL TESTS
- A.
- Preparation of extract and blank
- B.
- Tests on the extract
- 1.
- Oxidizable matter
- 2.
- Chloride
- 3.
- Ammonia
- 4.
- Phosphoric acid — phosphate
- Limit test for phosphate
- 5.
- Acidity or alkalinity
- 6.
- Residue on evaporation
- 7.
- Clarity and colour
- 8.
- Taste and smell
- 9.
- Special elements
- 10.
- Residue on ignition
- 11.
- Heavy metals
- II. BIOLOGICAL TESTS
- III. REQUIREMENTS FOR ANTICOAGULANT SOLUTION IN PLASTICS CONTAINERS
- Appendix
- BIOLOGICAL TEST: LIMITS AND METHODS
- A.
- Test for undue toxicity
- B.
- Test for freedom from pyrogens
- C. Test for haemolytic effects in buffered systems
- D.
- Test for the
- in vivo
- survival of red cells
Feedback