8 — Labels, leaflets and certificates Europese Overeenkomst inzake de uitwisseling van reagentia voor weefseltypering
Labels, leaflets and certificates
Two labels, one printed in English and one in French, in black on white paper, shall be affixed to each final container and shall contain the following information:
a. name and address of producer,
b. the specificity of the reagent,
c. name and amount of antiseptic and/or antibiotic, if present, or indication of absence,
d. the volume or, when the reagent is dried, the volume and composition of the fluid needed for reconstitution,
e. expiry date,
f. identification,
g. conditions of storage,
h. results of the test for HBsAg.
Moreover, the leaflet accompanying the containers shall include the following information:
a. full name and address of producer,
b. the recognised specificity of the reagent,
c. the volume or, when the reagent is dried, the volume and composition of the fluid needed for reconstitution,
d. date of last potency test,
e. expiry date (if any),
f. identification and (if possible) the name of the reagent,
g. adequate description of the method of use recommended by the producer including technique, volume and dilution to be used,
h. conditions of storage of unopened ampoules and precautions to be taken after opening,
i. exact composition, including antiseptic and/or antibiotic if any,
j. statement whether the product contains or does not contain material of human origin.
k. the reaction score + + ,-+, +-, - -, and the values of coefficient r (serum/antigen).
Each consignment shall be accompanied by a certificate as provided in Article 4 of the Agreement and the Annex to the present Protocol. Examples of label and leaflet are attached to the present Protocol.
- Regeling
- Europese Overeenkomst inzake de uitwisseling van reagentia voor weefseltypering
- Soort
- Verdrag
- Geldend vanaf
- 28-03-1985
- BWB-id
- BWBV0004016
- Versie
- 1985-03-28_0