Appropriate education, knowledge and experience

The person responsible for pharmacovigilance must have a suitable education, knowledge and experience in the field of pharmacovigilance.

Appropriate education denotes:

  •  secondary level of education in medicine for medicinal products for human use or another compliant level of education as per the law;
  • and a secondary level of education in veterinary medicine for medicinal products used in veterinary medicine or another suitable level of education as per the law.

If the person responsible for the pharmacovigilance system has not had a suitable education, they must be given a permanent and continuous opportunity to acquire expert support from a person with a suitable education.

Supporting evidence

Diploma: certified or non-certified copy and the original provided on request. Certificate of knowledge and experience in the field of pharmacovigilance

Last updated: 08. 01. 2016