FAQs
MAH transfer
According to NtAs variation Guideline on Dossier requirements for Type IA and Type IB Notifications Revision 1 (July 2006), the condition for a MAH transfer to be classified as Type IA no 1 is that "The marketing authorisation holder shall remain the same legal entity."
If it is not the same legal entity the variation is a special variation. We accept that this is a national change as the MAH can be different in different countries.
We need to have a proof of establisment i.e. a letter of agreement between the new MAH taking over the responsibilities and the previous MAH.
We also need updated SPCs and PILs and information about when the change is going to be implemented. Finally we need a specimen or mockup of labelling for every type of presentation (pack size and type) with information about the new MAH when available and at least within a year from the date of approval.
Electronic Applications
Clinical Trials
Is it sufficient to send in one application for a multi-centre trial?
In the case of a multi-centre investigation one application is sufficient.
When a sponsor reports a serious adverse reaction into the EudraVigilance database with IMA and EMA as recipients, does the report appear twice?
No, the adverse reaction is only reported once into the European database EudraVigilance.
How do I apply for a EudraCT number?
Apply for the EudraCT number through EMEA's website: http://eudract.emea.europa.eu
Product Classifications
What rules apply for import of food supplements for individuals?
It should be noted that The Environmental Agency supervises the surveillance of food supplements cf. Regulation No 624/2004 on food supplements
A general product must not contain substances classified by IMA to be permitted only in products manufactured as medicinal products and receiving marketing authorisations as such.
On the page to the left there are lists of classifications of herbs and common ingredients and permitted maximum daily doses of vitamins and minerals. A specific substance can be classified by comparison with the lists.
If a doubt arises as to the classification of individual ingredients it should be noted that the agency classifies formally such ingredients, with fees for such a classification being in accordance with the agency’s rate list
Pharmacovigilance
Is the Icelandic Medicines Agency ready for the production phase?
Yes, see section 4.1.2 for instructions.
Is a testing phase mandatory?
No. When a MAH has completed a testphase with EMEA further testing is not required with IMCA.
Is submission of paper/fax copies necessary in parallel with electronic reporting?
No, but Icelandic representatives of MAHs are required to send a copy to IMA when they send a report to their Qualified Person. This is for regulatory purposes and to avoid duplicate submission.
How do MAHs receive ICSRs from IMA?
Electronic transmission is a two way communication. The MAHs are required to send all ICSRs electronically (to ADALIMCA01), as described above. Likewise, all transmissions of ICSRs from IMA to MAHs can be sent via the same EudraVigilance-gateway. If a MAH wishes to enter into such communication with IMA please send a request to ima@ima.is or via the Icelandic representative. Currently IMA sends a paper-copy of the report the Icelandic representatives of MAHs. All ICSRs sent to the MAHs are also transmitted to EMEA. We use the acknowledgment files from EMEA to validate the correctness of the reports according to EMEA business rules. If the report is considered valid and correct by EMEA, we consider it to be valid also towards the MAHs.
What causality assessments does IMA use when evaluating reports.
IMCA uses the WHO causality assessment of suspected adverse reactions
Does IMA receive consumer reports?
Yes, IMCA has started a trial project for receiving consumer reports. The reports do not have to be medically confirmed.
