Services for human medicinal products
  • General PhV consultation
  • Review of the company’s existing PhV system and strategy (PhV and regulatory) to comply with the new PhV legislation
  • Preparation and implementation of the Pharmacovigilance System Master File (PSMF) and the new PhV – Quality System (including Standard Operating Procedures – SOPs)
  • QPPV services
  • Handling and submission of the mandatory data according to Art. 57(2) of the EU regulation 726/2004 (XEVMPD)IMGP6650-382x494
  • Delegation of various PhV activities and responsibilities
  • PhV Audit
  • Establish the link with the regulatory affairs department
  • PhV Training
Services for veterinary medicinal products
  • General PhV consultation
  • Review of the company’s existing PhV system and strategy to comply with volume 9B
  • Preparation and implementation of the Detailed Description of the Pharmacovigilance System (DDPS, including Standard Operating Procedures – SOPs)
  • QPPV services
  • Delegation of various PhV activities and responsibilities
  • PhV Audit
  • Establish the link with the regulatory affairs department
  • PhV Training

Pharmacovigilance Update

Billev Pharma has intensely followed the implementation of the new pharmacovigilance (PhV) legislation and we are ready to help your company fulfil the obligations of the new requirements.

  • Does your company have a complete overview of the new PhV legislation for human medicinal products that entered into force July 2012?
  • Is your company aware of the differences between previous and current PhV legislation and how it affects different departments and internal processes?
  • Is your company fully compliant with the requirements and prepared to submit a copy of the Pharmacovigilance System Master File (PSMF) within 7 days upon request from the Authorities?

OR is your company:

  • facing delays of new submission due to the requirements to have a PSMF in place?
  • at risk of losing existing Marketing Authorisations due to the requirement to switch to the PSMF upon renewal?
  • still struggling with the submission of mandatory data to XEVMPD in accordance with EU regulation 726/2004 Art. 57(2) and wondering how will you manage the maintenance of the data?
  • at risk of facing major findings during a PhV inspection* due to the new PhV requirements?

Billev Pharma is ready to provide you with the necessary services to cover for these situations and other implications of the new pharmacovigilance legislation.


* The new pharmacovigilance legislation contains legal basis for the conduct of pre-authorisation pharmacovigilance inspections.