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Schedule-11 (Relating to Rule 21)

Schedule-11
(Relating to Rule 21)
The Particulars to be Made Available While Making Application for the
Production, Sale and Distribution or Import of Biological Product

1. Name and address of the producer).
2. Trade and generic name of the biological).
3. Physical, chemical and biological properties and mechanism of action of the
Biologicals.
4. Description of the prophylactic, curative or diagnostic properties of the Biologicals .
5. Data on harmlessness effect, immunogenic effect and side effects of Biologicals.
6. Description of methods of qualitative and quantitative control. [Efficacy, quality and
safety] 7. Comparative assessment of the Biologicals on immunological or diagnostic
effectiveness in comparison with other similar preparations (if any).
8. Indications, contra-indications, and compatibility with other Biologicals and
veterinary drugs.
9. Precautions that must be observed during the production, transportation, storage and
use of the Biologicals.
10. Instructions concerning the use of the biological preparation, ways of application,
dosage, storage and packing.
11. Label on the trade packing.
12. Other information (if any).

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