MA Holders

MA Holder Registration Process

• Download a joint communication from Icelandic Medicines Agency and ICEMVO
• Download the ICEMVO participation agreement

What do I need to do next?

1. Check if your MAH company has any products in Iceland to which the 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.

2. Register with ICEMVO: Please download the ICEMVO Participation Agreement from the ICEMVO website, fill in Exhibit C and D to register contracting company information and MAH information.

3. Sign the participation agreement: After completing the relevant sections of the agreement, including Exhibits C and D, have the agreement signed by an authorised signatory of the company and the Icelandic Representative (if applicable) and return in pdf format to info@lyfjaaudkenni.is. 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.