Audit and inspection Q&A

This page provides answers to questions about audit and inspection in relation to the new pharmacovigilance legislation.

Blister pack with white tablets1. What are the new requirements for Pharmacovigilance Systems Information provided to Competent Authorities?

2. From when does a pharmacovigilance system master file need to be in place?

3. How do I introduce a pharmacovigilance system master file?

4. What are the new requirements for Quality Systems?

5. Are there any changes to inspections?
 


1. What are the new requirements for Pharmacovigilance Systems Information provided to Competent Authorities?

The requirements for information provided to Competent Authorities and the European Medicines Agency (EMA) about the pharmacovigilance system(s) of marketing authorisation holders (MAHs) change in several ways:

  • Summary information only concerning the EU qualified person for pharmacovigilance (QPPV) and the location of a pharmacovigilance system master file will be contained in marketing authorisations.
  • Full descriptive information about the pharmacovigilance system will have to be contained in a pharmacovigilance system master file, which should be made available to the National Competent Authorities upon request.
  • Detailed requirements for the pharmacovigilance system master file concern its availability, structure, content and maintenance.
  • The pharmacovigilance system master file will encompass the pharmacovigilance system and may therefore relate to one or more products, and changes to its content will not be automatically notifiable to the Competent Authorities. This differs from the current Detailed Description of the Pharmacovigilance system (DDPS), which will be phased out over the period from July 2012 to 2015.
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2. From when does a pharmacovigilance system master file need to be in place?

The new Directive contains a transitional period for the introduction of the pharmacovigilance system master file, ending in July 2015. It is mandatory for all new marketing authorisation (MA) applications after July 2, 2012, (centrally authorised products) and July 21, 2012 (all other authorisation types), and must be introduced on renewal of products in the transition period. By the end of the transition period, pharmacovigilance system master files will have to be in place for all products authorised in the EU/EEA.

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3. How do I introduce a pharmacovigilance system master file?

For products undergoing renewal, or those with an existing DDPS, an update to the MA is required, since the summary information (location of the pharmacovigilance system master file) needs to be introduced and the obligations concerning the DDPS removed. This needs to be in the form of as a variation. The variations classification guideline is being updated in light of the new legislation. The MHRA will accept introduction of a pharmacovigilance system master file, via variation, anytime after the new legislation comes in to force.

For further information on the relevant variations and on how to acquire a PSMF number, see the EMA Q&As (external link).

For all products, by the end of the transition period, the location of the pharmacovigilance system master file must have been entered in the database described in Article 57 of the Regulation ‘XEVMPD’.

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4. What are the new requirements for Quality Systems?

Detailed requirements on the minimum requirements for the quality system to support the pharmacovigilance system are introduced (see GVP Module I). MAHs, national Competent Authorities and the EMA will be required to have a quality system in place which covers their pharmacovigilance activities, and documentation of the system will be necessary. The principle is that pharmacovigilance should be governed and managed in such a way that quality principles are routinely applied—particularly for resource management, staff training, procedural documentation, quality control, monitoring, and improvement.

EMA pharmacovigilance practices (GVP) modules (external link)

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5. Are there any changes to inspections?  

We operate a national programme of pharmacovigilance inspections, which includes those that contribute to the EU inspection programme for centrally authorised products, conducted on behalf of the Community. Information about inspections is shared with other Member States and the EMA. The new legislation re-enforces the cooperation and harmonisation of inspection activities in the EU.

The new Regulation contains the legal basis for the conduct of pre-authorisation inspections. There is also a clear requirement for an adequate pharmacovigilance system as a condition of marketing authorisation. MA applicants should be aware that the pharmacovigilance system master file may be requested for review during the application process and an inspection may be conducted to establish the adequacy of the (proposed) pharmacovigilance system before authorisation.   

The supervisory responsibilities of national Competent Authorities remain unchanged, except that, for centrally authorised products, the Supervisory Authority will be determined by the pharmacovigilance system master file location.   

The MHRA will continue to operate a risk-based inspection programme, based on the information provided by companies in the compliance questionnaire, which is requested periodically, usually on a biennial basis.

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Page last modified: 13 August 2012