New legislation for pharmacovigilance applies in the European Union (EU) since July 2012, and to support its implementation, a set of guidelines for the conduct of pharmacovigilance in the EU has been developed which, as they have been adopted, replaced the previous set in Volume 9A of the Rules Governing Medicinal Products in the EU.
This new guidance on good pharmacovigilance practices (GVP) is organised into two types of chapters, namely Modules on pharmacovigilance processes and Product- or Population-Specific Considerations.
History of the GVP development process and latest updates
The first seven Modules on prioritised processes were consulted between 21 February and 18 April 2012 and revised, taking into account the comments received from stakeholders. They were available in their first final versions which came into force on 2 July 2012.
Module III on pharmacovigilance inspections and Module X on processes for additional monitoring of medicinal products were released on 27 June 2012 for public consultation until 24 August 2012, and Module IV on pharmacovigilance audits and Module XV on safety communication were released on 26 July 2012 for public consultation until 21 September 2012. Modules III and IV were published in their final versions, together with the updated GVP Annex I on definitions, on 13 December 2012. The final Module XV was published on 24 January 2013, together with a Template for Direct Healthcare Professional Letters in the GVP Annex II. On 25 April 2013, the final Module X on additional monitoring was published as final, taking into account latest additional legislation.
Since their first release as final, some Modules have been revised as final, and further Modules and Product- or Population-Specific Considerations chapters have been issued:
Module II was published in its first revision, mainly to provide clarifications for herbal medicinal products, on 12 April 2013. Module VIII Revision 1 and its Addendum Revision 1 as well as in Annex II – Template for the PSUR Cover Page Revision 1 were published on 25 April 2013.
On 7 June 2013, the draft revision 1 of Module VI on the management and reporting of adverse reactions was released for public consultation, in order to provide more guidance on the clock state for reporting of valid case reports, reporting from post-authorisation safety studies as well as the handling of languages. Also on 7 June 2013, draft Module XVI on risk minimisation measures was released for public consultation. Both consultations closed on 5 August 2013. Module XVI was published in its final version on 28 February 2014; and revision 1 of Module VI was published as final on 15 September 2014.