New EMA Guidance on Pharmacovigilance Legislation

Global Life Sciences: EU Update

The European Medicines Agency (“EMA”) recently published new guidance on the initial phases of operation of the new EU pharmacovigilance (“PV”) legislation which becomes applicable in July 2012. The new guidance has been published in the form of a question-and-answer document (“Q&A”) and applies to all medicinal products for human use.

The Q&A provides answers to procedural questions regarding the implementation of the new legislation and covers the following themes: (1) good PV practices (“GPV”); (2) PV system master file and summary of the PV system; (3) risk management plan; (4) post-authorization safety studies (“PASS”); (5) periodic safety update reports (“PSUR”) and EU reference data list; (6) literature monitoring; (7) product information and the black symbol; (8) adverse drug reaction reporting and signal management; and (9) renewals.

The new guidance clarifies, for example:

  • the dates from and by which applicants and existing marketing authorization (“MA”) holders must provide a summary of their PV system;
  • the need to include a risk management plan in all initial MA applications, including generic MA applications, after 2 July 2012 (for centrally authorized products; “CAPs”) and 21 July 2012 (for nationally authorized products; “NAPs”);
  • that the new procedures for submission and assessment of PASS protocols, substantial amendments and final study results only apply to PASS imposed after 2 July 2012 (for CAPs) and 21 July 2012 (for NAPs) as a condition to the MA; and
  • that the single assessment procedure of PSURs involving only NAPs will not start in 2012, that further information will be provided in 2013, and that a six-month transitional period for the application of the new PSUR format and content is being considered.

The EMA guidance document is available here and should be read in conjunction with the European Commission’s February 2012 Q&A on transitional arrangements available here. The Q&A represents the view of the EMA as well as the EU Member States, and has been subject to consultation with the European Commission. The EMA has indicated that it intends to update the new guidance document regularly on the basis of additional questions received from stakeholders.

We recommend that stakeholders review the new EMA guidance document in full and assess whether and how the information impacts them. To the extent that questions remain unanswered by the European Commission and EMA guidance documents, stakeholders may submit new questions to the EMA, using the e-mail address provided here.

The EU Life Sciences Practice of Sidley Austin LLP

For further information on the EU Life Sciences Practice, please contact: Maurits J.F. Lugard (+32.2.504.6417,, Maarten Meulenbelt (+32.2.504.6467, or Kristina Nordlander (+32.2.504.6449,

Sidley Global Life Sciences Practice

For further information on the Global Life Sciences Practice, please contact: Scott Bass (+1.202.736.8684/+1.212.839.5613, or James C. Stansel (+1.202.736.8092,

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This Global Life Sciences: EU Update has been prepared by Sidley Austin LLP for informational purposes only and does not constitute legal advice. This information is not intended to create, and receipt of it does not constitute, a lawyer-client relationship. Readers should not act upon this without seeking advice from professional advisers.

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