Amendment of instruction about the implementation procedure of the

Information Note
Agencia Española de Medicamentos y Productos Sanitarios
AEMPS
AMENDMENT OF INSTRUCTION ABOUT THE
IMPLEMENTATION PROCEDURE OF THE
EUROPEAN DECISION REGARDING VETERINARY
MEDICINES ‘FORTEKOR’ AND ASSOCIATED NAMES
Date of publication: 7th June 2012
Category: AEMPS, VETERINARY MEDICINES, INDUSTRY.
Reference: MVET, 04_vi /2012
On the 20th February 2012 the AEMPS adopted the instruction 2/2012
regarding the procedure of implementation in Spain of the European
Decision regarding veterinary medicines “FORTEKOR and associated
names”.
On the second point of the instruction, it was established that Marketing
Authorisation Holders of the rest of veterinary medicines containing
Benazepril hydrochloride, should submit the corresponding variation aimed
to adapt their medicines to the conclusions of the Decision.
Taking into account that this Decision was based on the legal basis of
article 34 of the Directive 2001/82/CE of the European Parliament and of
the Council which only applies to veterinary medicines FORTEKOR and
associated names, but not to all of veterinary medicines containing
Benazepril hydrochloride, through this instruction the AEMPS overrides
the second point of instruction 2/2012.
References
AEMPS. [Web]. 24th February 2012. Information Note Instruction about the implementation
procedure of the European Decision regarding veterinary medicines “FORTEKOR” and
associated names. Ref. MVET, 01_vi/2012. Available on:
http://www.aemps.gob.es/en/informa/notasInformativas/medicamentosVeterinarios/2012/NI
-MVET_01-2012.htm (link revised on 7th June 2012).
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