Management of GTIN numbers

The Icelandic Medicines Agency (IMA) supervises the implementation of the rules on safety features of medicinal products and also provides pharmaceutical companies with access to IMA's GTIN system for the management of GTIN numbers.

Pharmaceutical companies are responsible for managing GTIN numbers (Global Trade Item Number), i.e. ensuring that they are registered for the pack concerned down to the product number. This is done through a system at IMA.

Access to the system is applied for via Contact us at IMA. The email address, name and telephone number must be entered there. In addition, it is important to state the name of the company. To ensure that the request reaches the right place, it is important to enter „Ósk um aðgang að umsýslukerfi GTIN númera“ (Request for access to the GTIN number management system) in the subject line and to select „Annað“ (Other) from the subject list.

GTIN numbers and the medicines verification system

In the medicines verification system (FMD), the GTIN may be used as the product code, which is part of the unique identifier of a medicine pack. In addition to the product code, the unique identifier contains, among other things, a serial number, batch number and expiry date.

Lyfjaauðkenni ehf. (ICEMVO) operates the Icelandic medicines verification system, which is part of the European Medicines Verification System. For information on registration, technical connection, access to or use of the medicines verification system, contact Lyfjaauðkenni.

Laws and Regulations

In February 2016, a regulation (Delegated Regulation (EU) 2016/161) was published in the Official Journal of the EU to support the Union's directive (Directive 2011/62/EU) on falsified medicines. These rules introduced new safety standards on how to prevent falsified medicines from entering the medicines supply chain and ultimately reaching patients. The Regulation took effect on 9 February 2019, by which time the EU Member States and the EEA States Norway, Iceland and Liechtenstein had completed the implementation of the safety features of medicinal products provided for in the Directive.