BTVPUR (bluetongue-virus serotype-1 antigen...) – Conditions or restrictions regarding supply and use - QI04AA02
Updated on site: 08-Feb-2018
|Substance:||bluetongue-virus serotype-1 antigen /bluetongue-virus serotype-8 antigen|
A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Name and address of the manufacturer of the biological active substance
MERIAL Animal Health Limited
Biological Laboratory, Ash Road,
Pirbright, Woking, Surrey GU24 0NQ
MERIAL Laboratoire de Lyon Gerland 254, rue Marcel Mérieux
69342 LYON CEDEX 07 France
Name and address of the manufacturer responsible for batch release
Laboratory of Lyon Porte des Alpes Rue de l’Aviation,
B.CONDITIONS OR RESTRICTIONS OF REGARDING SUPPLY OR USE
Veterinary medicinal product subject to prescription.
According to Article 71 of Directive 2001/82/EC of the European Parliament and of the Council as amended, a Member State may, in accordance with its national legislation, prohibit the manufacture, import, possession, sale, supply and/or use of immunological veterinary medicinal products on the whole or part of its territory if it is established that:
a)the administration of the product to animals will interfere with the implementation of a national programme for the diagnosis, control or eradication of animal diseases, or will cause difficulties in certifying the absence of contamination in live animals or in foodstuffs or other products obtained from treated animals.
b)the disease to which the product is intended to confer immunity is largely absent from the territory in question.
The use of this veterinary medicinal product is only allowed under the particular conditions established by European Community legislation on the control of Bluetongue.
C.STATEMENT OF THE MRLs
The active substance being a principle of biological origin intended to produce active immunity is not within the scope of Regulation (EC) No 470/2009.
The excipients (including adjuvants) listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required.