EMA Implementing Annual Pharmacovigilance Fee Beginning in July

Starting July 1, drugmakers must pay an annual pharmacovigilance fee of $70 for each product they market in the EU.

The fee covers the period from Jan. 1 to Dec. 31, 2015, the European Medicines Agency says in an explanatory note issued this week on fees adopted in a regulation last year.

The revenue will be used to pay for the EMA’s pharmacovigilance activities, including monitoring of scientific literature for cases of adverse drug reactions and improved use of information technology tools, the agency says.

Micro enterprises are exempt from paying the fee, while small- and medium-size companies get a 40 percent reduction. Manufacturers of generic drugs and “well-established use” drugs are entitled to a 20 percent feed reduction.

The EMA began charging procedural fees for safety monitoring last August. They are: $20,500 for reviewing periodic safety update reports, $45,500 for reviewing postauthorization safety study protocols and study results and $190,000 for conducting pharmacovigilance-related investigations for a drug with one or two active substances. Some exemptions and reductions are available.

The fees are based on the EU’s 2012 pharmacovigilance legislation, which requires that marketing authorization holders pay for the EMA’s surveillance activities. Read the explanatory note at www.fdanews.com/03-15-EMA-Fees.pdf . — Jonathon Shacat