Marketing authorisation holders (MAH's) must ensure that restrictions and conditions to the marketing authorisation of medicinal products, regarding their safe and effective use, are implemented to minimize the risk of their use. In many cases the MAH's must publish and distribute educational material for healthcare professionals and/or patients. All such material must be approved by the IMA before it is published and distributed. Healthcare professionals and dentists that prescribe or dispense these medicinal products must be aware of these conditions and follow the guidelines to ensure their safe and effective use.
The IMA has released guidelines for MAH regarding educational materials (aRMM)
- Instructions for submitting educational materials (aRMM) for evaluation and review
- Application form for request of review of educational materials
Publication of educational materials on the medicinal product information website (www.serlyfjaskra.is)
Marketing authorisation holders are encouraged to submit both new and previously approved educational materials for publishing at www.serlyfjaskra.is. Please follow the instructions here below.
Agreement regard the labelling of risk communication 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.
Allergan Pharmaceuticals International Ltd.
Allergen Pharmaceuticals Ireland
Alvogen IPCo S.à.r.l.
Arthropharm Europe Limited
Bayer Animal Health GmbH
BGP Products AB
BGP Products Aps
BGP Products Ltd
Bioglan Pharma AB
BioMarin International Limited
Ceva Sante Animale
Chanelle UK Limited
Chiesi Farmaceutici SpA
Clintec Parenteral SA
Colgate Palmolive A/S
CSL Behring AB
Daiichi Sankyo Europe GmbH
Dentsply De Trey
Dopharma Research B.V.
Elan Pharma International Ltd.
Elanco Animal Health A/S
Fresenius Medical Care
Gedeon Richter Nordics AB
Generics Ltd UK
Genzyme Europe B.V.
Intendis GmbH Berlin
Janssen Biologics B.V.
Kela Laboratories NV
Les Laboratories Servier
Linde Healthcare – ÍSAGA
Lohmann Animal Health
Medical Valley Invest AB
The Medicines Company UK Limited
medac Gesellschaft für klinische Spezialpräparate GmbH
Medice Arzneimittel Pütter GmbH & Co. KG
Medimpex UK Limited
Menarini International Operations Luxembourg S.A.
Mentholatum Company Ltd.
Mylan Hospital AS
Orifarm Generics A/S
Pfizer Oy Animal Health
Pharma Nord ApS
Raptor Pharmaceuticals Europe B.V.
Reckitt Benckiser Healthcare
Shire Pharmaceuticals Ltd.
Smith & Nephew
STADA Arzneimittel AG
Swedish Orphan Biovitrum (Sobi)
Tillotts Pharma AB
United Therapeutics Europe Ltd.
Zogenix ROI Ltd.
Williams & Halls ehf.
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, a request has to be submitted to the IMA using the email address [email protected]