Agreement regarding the labelling of Risk Communication Material
Agreement regarding the labelling of risk communications and educational material for healthcare professionals
The Icelandic Medicines Agency (IMA) and the Icelandic Association of the Pharmaceutical Industry (Frumtök) have in cooperation designed a symbol which is intended to help healthcare professionals (HCPs) distinguish between important risk communications/educational material sent in agreement with IMA and other material sent by marketing authorisation holders (MAHs), e.g. promotional material.IMA and the Icelandic Association of the Pharmaceutical Industry (Frumtök) signed an agreement regarding the use of this symbol on 29 November 2012.
All MAHs are invited and encouraged to apply for the use of this symbol by becoming part of the aforementioned agreement. In order to be allowed to use the symbol, an e-mail has to be submitted to IMA ([email protected]), where the MAH requests to be 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, i.e.:
- Educative material published for centralised products to fulfill CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT in Annex II, C/D of their marketing authorisation,
- Educative material published for medicinal products following a referral, in accordance with a Commission Decision,
- Educative material published in agreement with IMA, due to commitments in a RMP approved by the rapporteur/RMS/NA,
- Risk communication sent due to requirements of EMA/IMA and in agreement with IMA, after IMA´s assessment, e.g. Direct Healthcare Professional Communication letters (DHPCs).
It is strictly forbidden to use the symbol in context with promotional material.
The symbol should be used to label envelopes (on a sticker/label or printed on the envelope itself, in colour). The location on the envelope is not specified but it should be clearly visible. The IMA also recommends the use of the symbol on Direct Healthcare Professional Communication (DHPC) letters, e.g. in the header of the first page. This also applies to any annexes to specific safety information and educational material.
Notwithstanding this additional field of application the label shall always be used on envelopes, whether the contained documents are identified in the same manner or not.
The symbol can only be used for material which is distributed upon request or by special permission of the agency.
MAHs who have joined the agreement are:
| Abbott |
| Abbvie |
| Accord |
| Actavis |
| Actelion Registration |
| Alcon |
| ALK-Abelló |
| Allergan Norden |
| Allergan Pharmaceuticals International Ltd. |
| Allergen Pharmaceuticals Ireland |
| Alvetra GmbH |
| Alvogen IPCo S.à.r.l. |
| Amgen |
| Arthropharm Europe Limited |
| Astellas |
| AstraZeneca |
| Baxter |
| Bayer |
| Bayer Animal Health GmbH |
| Bene-Artzneimittel GmbH |
| BGP Products AB |
| BGP Products Aps |
| BGP Products Ltd |
| Biogen Idec |
| Bioglan Pharma AB |
| Biomarin International Limited |
| BMS |
| Boeringer Ingelheim |
| CCS |
| Celgene |
| Celltrion |
| Ceva Sante Animale |
| Chanelle UK Limited |
| Cheplapharm Arzneimittel |
| Chiesi Farmaceutici SpA |
| Clintec Parenteral SA |
| Colgate Palmolive A/S |
| CSL Behring AB |
| Daiichi Sankyo Europe GmbH |
| Dentsply De Trey |
| Desitin Arzneimittel |
| Diurnal |
| Dopharma Research B.V. |
| Eisai |
| Elan Pharma International Ltd. |
| Elanco Animal Health A/S |
| Eli Lilly |
| Expanscience |
| Ferring |
| Fresenius Kabi |
| Fresenius Medical Care |
| Galderma |
| GE Healthcare |
| Gedeon Richter Nordics AB |
| Generics Ltd UK |
| Genzyme Europe B.V. |
| Gilead |
| Grünenthal GmbH |
| GSK |
| Hospira |
| Intendis GmbH Berlin |
| Intercept |
| Janssen Biologics B.V. |
| Janssen-Cilag |
| JSC Grindeks |
| Kela Laboratories NV |
| Kyowakirin |
| LEO Pharma |
| Les Laboratories Servier |
| Linde Healthcare - ÍSAGA |
| Lohmann Animal Health |
| Lundbeck |
| LYFIS |
| Martindale Pharmaceuticals |
| The Medicines Company UK Limited |
| MEDA |
| medac Gesellschaft für klinische Spezialpräparate GmbH |
| Medical |
| Medice Arzneimittel Pütter GmbH & Co. KG |
| Medilink |
| Medimpex UK Limited |
| Menarini International Operations Luxembourg S.A. |
| Mentholatum Company Ltd. |
| Merck |
| MercuryPharma |
| MSD |
| Mylan AB |
| Mylan Hospital AS |
| Mylan SAS |
| Norbrook |
| Nordic Drugs |
| Norpharma A/S |
| Novartis |
| Novo Nordisk |
| Octapharma Nordic |
| Orifarm Generics A/S |
| Orion Corporation |
| Otsuka |
| Pfizer |
| Pfizer Oy Animal Health |
| PharmaCoDane |
| Pharmacosmos A/S |
| Pharma Nord ApS |
| Pierre Fabré |
| Raptor Pharmaceuticals Europe B.V. |
| Reckitt Benckiser Healthcare |
| Recordati AB |
| Roche |
| Sandoz GmbH |
| Sanofi |
| Sanofi-Pasteur MSD |
| Santen Oy |
| Shire Pharmaceuticals Ltd. |
| SkyePharma PLC |
| Smith & Nephew |
| STADA Arzneimittel AG |
| Swedish Orphan Biovitrum (Sobi) |
| Takeda |
| TEVA |
| Thea |
| Therakind Ltd |
| Tillotts Pharma AB |
| UCB |
| United Therapeutics Europe Ltd. |
| Vétoquinol |
| Vian S.A. |
| Vifor Pharma |
| Vivus BV |
| Williams & Halls ehf. |