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EU AGENCIES: EMCDDA and EMA enhance cooperation

EU drugs and medicines agencies amend working arrangement today in light of recent legislation

Lisbon, 07.09.2012 (Fact sheet No 7/2012)

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EMCDDA and EMA Directors
EMCDDA and EMA Directors

Exchanging information on new psychoactive substances and abused medicines is enhanced today, thanks to an amended working arrangement signed in Lisbon by the European Monitoring Centre for Drugs and Drug Addiction (EMCDDA) and the European Medicines Agency (EMA) (1). The signatories were EMCDDA Director Wolfgang Götz and EMA Executive Director, Guido Rasi.

Today’s arrangement updates that signed by the agencies in 2010 and furthers cooperation between them. It was drawn up in the light of newly applied EU legislation on pharmacovigilance designed to strengthen Europe’s system for medicines safety. The legislation was adopted in 2010 and applies from 2 July 2012 (2).

The two EU agencies have worked closely together since 1997 when they began exchanging information on, and assessing the risks of, new synthetic drugs in Europe (3). Since 2005, they have cooperated in implementing the three-step legal instrument through which Europe now monitors and acts on new psychoactive substances (4).

According to the new legislation, the EMA and the EMCDDA ‘shall exchange information that they receive on the abuse of medicinal products including information related to illicit drugs’. New to the arrangement signed today is that the EMA will now inform the EMCDDA of any ‘validated signals’ (5) on the suspected side effects of medicinal products related to drug abuse. The arrangement strengthens the agencies’ information exchange practices and will help them respond in a more timely manner to potential public health threats.

Other features of the arrangement include the exchange of expertise (e.g. via consultations, projects, meetings) and the possibility for the EMA to consult the EMCDDA when defining risk management plans for selected medicinal products.

The agencies are currently collaborating in an ongoing European investigation into the health and social risks of the new psychoactive substance 4-methylamphetamine.


(1) Full text of the ‘Working arrangement’.

(2) See EMA press release of 2.7.2012 at ‘News and events’ and Article 28c of the new legislation.

(3) 1997 Joint action on the information exchange, risk assessment and control of new synthetic drugs.

(4) 2005 Council Decision on the information exchange, risk assessment and control of new psychoactive substances. This repealed the above Joint action while building on its achievements and maintaining its three-step approach (information exchange/early-warning; risk assessment; decision-making/control).

(5) A safety signal in the form of information on a new or known adverse event that is potentially caused by a medicine and that warrants further investigation. For a signal to be validated, raw data needs to be reviewed and enough evidence found to justify further analysis.


An EMA news release is also available.

About the EMCDDA

The European Monitoring Centre for Drugs and Drug Addiction (EMCDDA) is the reference point on drugs and drug addiction information in Europe. Inaugurated in Lisbon in 1995, it is one of the EU's decentralised agencies. Read more >>

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Page last updated: Monday, 10 September 2012