FAQs
MAH transfer
Transfer of a marketing authorisation for a medicinal product to a third party – applies to national, as well as DCP and MRP authorisations.
The same application form shall be used when applying for a transfer of a marketing authorisation to a third party as for changes to the terms of a marketing authorisation. General provisions apply when filling out the form, except that stating the type of application or submitting a checklist is not required.
In order to support an application for an approval of a new marketing authorisation holder (MAH) a signed statement shall be submitted from competent representatives of the current as well as the prospective MAH (the same form may be used), as well as an updated SmPC and PIL, in accordance with general rules. Mock-up of an updated PIL, as well as updated packages shall be sent to the Icelandic Medicines Agency (IMA), when available, but still within the time-limit set out in a formal letter from the Agency.
The statement shall include the date from which the new MAH takes over all duties related to the medicinal product, i.e. from the date the transfer of the marketing authorisation comes into effect.
If the prospective MAH does not have a medicinal product with a marketing authorisation in Iceland, a description of the MAH´s pharmacovigilance system shall also be supplied. The statement should also contain the name of an Icelandic representative of the new MAH as well as of a wholesale distributor for the Icelandic market (if applicable).
Notification of a new representative – applies to all types of authorisation procedures
The same application form shall be used when notifying a new representative as for changes to the terms of a marketing authorisation. General provisions apply when filling out the form, except that stating the type of application or submitting a checklist is not required.
If the application covers two or more medicinal products only one form needs to be filled out if the application only relates to nationally authorised medicinal products. If the application also covers DCP, MRP and centrally authorised medicinal products a separate form must be completed for each procedure, where one form for two or more medicinal products is also sufficient.
The concerned medicinal products can either be listed in the appropriate places on the form itself or a reference can be made to an annex to the form, in which case the annex must contain all the information stipulated in the application form.
Along with the notification of a new representative there shall be a proposal for an updated PIL for nationally, DCP and MRP authorised medicinal products, in accordance with general rules. A mock-up of an updated PIL, as well as updated packages, if applicable, shall be sent to IMCA, when available, but still within the time-limit set out in the formal letter from the Agency.
It is anticipated that PILs for centrally authorised medicinal products will be updated in connection with the EU Commission´s update of the same information and then consequently a mock-up would be sent to the Agency.
The MAH shall send the above-mentioned application to the Agency, but in case somebody else does it a statement from the MAH shall be appended to the application specifying who is authorised to apply for the change and which change it covers. The application must have reached the Agency at least one month prior to the anticipated change to come into effect.
Notification of a changed name and/or an address of a representative – applies to all types of authorisation procedures
The same application form shall be used when notifying a changed name and/or an address of a representative as for changes to the terms of a marketing authorisation. General provisions apply when filling out the form, except that stating the type of application or submitting a checklist is not required.
If the application covers two or more medicinal products only one form needs to be filled out if the application only relates to nationally authorised medicinal products. If the application also covers DCP, MRP and centrally authorised medicinal products a separate form must be completed for each procedure, where one form for two or more medicinal products is also sufficient.
The concerned medicinal products can either be listed in the appropriate places on the form itself or a reference can be made to an annex to the form, in which case the annex must contain all the information stipulated in the application form.
Along with the notification of a changed name and/or an address of a representative there shall be a proposal for an updated PIL for nationally, DCP and MRP authorised medicinal products, in accordance with general rules. A mock-up of an updated PIL, as well as updated packages, if applicable, shall be sent to IMCA, when available, but still within the time-limit set out in the formal letter from the Agency.
It is anticipated that PILs for centrally authorised medicinal products will be updated in connection with the EU Commission´s update of the same information and then consequently a mock-up would be sent to the Agency.
The same provisions apply to the change of a name and/or an address of the holder of an licence for parallel-imported medicinal products.
The application must have reached the Agency at least one month prior to the anticipated change to come into effect.
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.