Art. 5 Protocol bij de Europese Overeenkomst betreffende de uitwisseling van geneesmiddelen van menselijke oorsprong, zoals gewijzigd

Human Specific Immunoglobulins contain antibodies against designated viral or bacterial agents. Therefore they may be prepared from pools of a limited number of donations. The following human specific immunoglobulins are included in these requirements: Human Immunoglobulin Anti-Tetanus Human Immunoglobulin Anti-Vaccinia. Other specific immunoglobulins may be developed and when the appropriate international standard is in existence they should be assayed in relation to that standard and their potency expressed in international units. Human Immunoglobulin Anti-Vaccinia shall contain not less than 500 IU per ml of vaccinia antibody as determined by a neutralisation test on chorio-allantoic membranes or in tissue culture. Human Immunoglobulin Anti-Tetanus shall contain not less than 50 IU per ml of tetanus antitoxin as determined by a neutralisation test in animals. Human Specific Immunoglobulins must further meet the requirements as described in section 4, Human Normal Immunoglobulin. Depending on the antibody content, the immunoglobulin concentration of the final solution may vary between 100 and 170 gram per litre. Labelling - The label on the container shall give all the information shown on the model label (Annex 5). In addition the label shall state the potency in international units in terms of the appropriate International Standard or International Reference Preparation.

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