MA Holder Registration Process
- Download a joint communication from Icelandic Medicines Agency and ICEMVO
- Download MAH registration form
What do I need to do next?
- Check if your MAH company has any products in Iceland to which the new safety feature requirements apply: A product authorised under the centralised procedure or a national procedure for sale or supply in Iceland is in-scope of the safety feature requirements from 9th Feb 2019 if it is: a prescription-only medicine in Iceland and NOT listed in Annex I (white list) to the Delegated Regulation or a non-prescription medicine (OTC product) LISTED in Annex II (black list) to the Delegated Regulation.
- Register with ICEMVO: Please use the form in Exhibit C or download the registration form from the MAH section of the ICEMVO website. More than one MAH can be registered using this form and please return by email to ICEMVO at email@example.com – please tag the email header: MAH Contract, thank you. A local affiliate or representative may return MAH registration forms for all the MAHs it represents.
- Pay the one-off registration fee: ICEMVO will invoice your Icelandic representative, or your company directly, for registration fee in accordance with the instructions provided on your MAH registration form (Exhibit C). Invoices are payable within 30 days.
- Sign the participation agreement: Please use the attached Participation Agreement form, or download the ICEMVO Participation Agreement from the ICEMVO website, fill in Exhibit C and D, have the agreement signed by an authorised signatory of the company and the Icelandic Representative and return in pdf format to firstname.lastname@example.org. We will countersign the contract and send it back to you in pdf format. Please note that it is not possible to change any other sections of the agreement.