Registration for import and/or distribution of active substance
According to Article 10(a) of Regulation No. 699/1996 on the importation, wholesale distribution and brokerage of medicinal products, importers and distributors of active substances intended for use in the manufacture of medicinal products must register their activities with the Icelandic Medicines Agency.
Processing
The Icelandic Medicines Agency has 60 days to review the application and must, during that period, assess the need for an inspection on the basis of a risk assessment. If the Icelandic Medicines Agency determines that an inspection is not required for the registration, the activities may commence 60 days after receipt of the application for registration.
If the Icelandic Medicines Agency determines that an inspection is required, the activities may not commence until the inspection and any related follow-up have been completed.
After the application is received by the Icelandic Medicines Agency, importers and/or distributors of active substances are registered in the European Medicines Agency database, EudraGMDP, following the Agency’s assessment or after completion of the inspection and related follow-up.
Importation of active substances
Importation of active substances refers to the importation of active substances from countries outside the European Economic Area (EEA).
Active substances intended for use in the manufacture of medicinal products that have a marketing authorisation in Europe may only be imported from countries outside the EEA. In addition, the following conditions must be met:
The active substances must have been manufactured in accordance with standards of good manufacturing practice that are at least equivalent to those required by the European Economic Area for the manufacture of medicinal products.
The active substances must be accompanied by written confirmation from the competent authority in the exporting country stating that the active substances are manufactured in accordance with standards of good manufacturing practice and that those standards are at least equivalent to those required by the European Economic Area for the manufacture of medicinal products. The written confirmation must also state that the manufacturer of the active substances is subject to regulatory supervision.
Distribution of active substances
Distribution of active substances refers to the distribution of substances that are manufactured or purchased within the EEA and distributed within the same area.
Instructions for registering an importer or distributor
New registration
The registration form must include at least the following information:
Company contact person
Name and permanent address
The active substances intended to be imported and/or distributed
If the active substances are imported from outside the EEA, the manufacturer and distributor must be registered, where applicable.
If the active substances are distributed within the EEA, only the active substance needs to be registered.
The following attachments must accompany an application for new registration:
General description of the intended activities
Company organisational chart
Drawings/layouts of the premises
Overview of the main equipment
Overview of quality documents and the main elements of the quality assurance system for the activities
Other documentation, if required
Registration of changes
The registration form must be completed so that the registration describes the intended changed activities for the importation or distribution of active substances.
The “Further information” field must include the active substances that are no longer imported or distributed, if applicable.
Not all supporting documents are required as attachments. However, a general description of the intended change must accompany the registration and be uploaded under “General description of the intended activities” in the application process.
Cost
The cost is in accordance with the current fee schedule of the Icelandic Medicines Agency at any given time, and the cost will be further specified during the processing of the application.
Service provider
Icelandic Medicines Agency