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QPPV Requirements in EU/EEA (Veterinary Products)

Should QPPV be a Veterinarian?

It is not mandatory for a QPPV to be a Veterinarian (Animal Doctor).

The QPPV should be appropriately qualified, with documented experience in all aspects of pharmacovigilance in order to fulfil the responsibilities and tasks of the post.

If the QPPV is not a veterinarian, access to a person qualified in veterinary medicine should be available.

Which countries in EEA require a local QPPV, besides a Central EEA-QPPV?

  1. France

  2. Hungary

  3. Portugal

What is the timeline /procedure for communicating Change in QPPV for Veterinary Medicine in EU/EEA

If a Detailed Description of Pharmacovigilance System (DDPS) is authorised as part of the marketing authorisation (MA), a change in QPPV should be submitted via a Type IAIN variation application (classification C.I.9.a, fee exemption applies), provided that the pharmacovigilance system itself remains unchanged.

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