Specific symbol to label risk communication in Iceland

All Marketing Authorization Holders (MAH) are invited and encouraged to use this symbol

18.12.2012

HCPs get a lot of mail from pharmaceutical companies and are often unable to distinguish important risk communication sent in agreement with medicines authorities, from other material sent by marketing authorisation holders, e.g. promotional material.
To enable HCPs to make this distinction, IMA and theIcelandic Association of the Pharmaceutical Industry (Frumtök) recently signed an agreement regarding the use of a symbol to label important risk communication/material sent in agreement with IMA, i.e.:
  • Educative material published for centralised products to fulfil CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT in annex II, C of their MA,
  • Educative material published for medicinal products following a referral, in accordance with Commission Decision,
  • Educative material published in agreement with IMA, due to commitments in RMP approved by rapporteur/RMS/NA,
  • Risk communication sent due to requirements of EMA / IMA and in agreement with IMA, after IMA´s assessment, e.g. DHPCs.

It is strictly forbidden to use it in context with promotional material.

All MAHs are invited and encouraged to apply for the use of this symbol by becoming a part of the aforementioned agreement.

  • How to apply: In order to be allowed to use the symbol, an e-mail has to be submitted to IMA (ima@ima.is), where the MAH requests to be a part of the agreement and thereby accepting its conditions, i.e. to use it and use it only for risk communication sent to the relevant HCPs in agreement with IMA, following the agency‘s assessment.
  • IMA aims at responding to such requests within a day.
  • How to get the symbol: Following IMAs acceptance the symbol will be sent to the MAH in the appropriate resolution.