Betekenis van:
potency

Voorbeeldzinnen

1. Batch titre or potency
2. change or addition of a new strength/potency;
3. information on the quantification of the different potency of malaoxon and malathion.’
4. the physical and chemical (potency and purity) test results for the relevant batch(es),
5. The Commission shall also ensure potency testing, formulation, distribution, bottling, labelling and transport of these antigens.
6. All antigens older than five years must be tested on their potency.
7. a constant pattern in the changing of the potency of the properties across the category.
8. For live vaccines, batches containing the minimum titre or potency shall be used unless justified.
9. vaccine potency testing characterised by persistent impairment of the animal’s condition, progressive disease leading to death, associated with long-lasting moderate pain, distress or suffering;
10. the replacement without delay of any used quantity of antigen by antigens of the same specification (serotype, topotype, Seed Master Strain) and at least the same quality (purification, potency etc.) and origin (manufacturer, marketing authorisation).
11. A quantification of the active substance shall be carried out on each batch to show that each batch will contain the appropriate potency or titre to ensure its safety and efficacy.
12. Relevant information shall be provided on the characterisation of the cell population or cell mixture in terms of identity, purity (e.g. adventitious microbial agents and cellular contaminants), viability, potency, karyology, tumourigenicity and suitability for the intended medicinal use.
13. It may be necessary to mention other hazards, such as dustiness, cross-sensitisation, suffocation, freezing, high potency for odour or taste or environmental effects such as hazards to soil-dwelling organisms, ozone depletion, photochemical ozone creation potential, etc., which do not result in classification but which may contribute to the overall hazards of the material.
14. The immunological veterinary medicinal product, which is the subject of the application, shall be identified by name and by name of the active substance(s), together with the biological activity, potency or titre, the pharmaceutical form, the route and method if appropriate of administration and a description of the final presentation of the product, including packaging, labelling and leaflet.
15. Therefore it is appropriate to require that the notifier submit further information as regards consumer intakes, the acute and long-term risk assessment for insectivorous birds, and on the quantification of the different potency of malaoxon and malathion, before authorisations are granted.