Bluevac BTV8 (bluetongue virus inactivated, serotype...) – Conditions or restrictions regarding supply and use - QI04AA02

Updated on site: 21-Sep-2017

Medication name: Bluevac BTV8
ATC: QI04AA02
Substance: bluetongue virus inactivated, serotype 8
Manufacturer: CZ Veterinaria S.A.

A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE

Name and address of the manufacturer of the biological active substance

CZ Veterinaria, S.A. La Relva s/n, 36400 Porriño SPAIN

Name and address of the manufacturer responsible for batch release

CZ Veterinaria, S.A. La Relva s/n, 36400 Porriño SPAIN

B.CONDITIONS OR RESTRICTIONS 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 programmes for the diagnosis, control and/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.

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 or considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.

D. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION

The current annual reporting cycle for periodic safety update reports (PSURs) should be maintained.

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