Registration for manufacturing of active substance
According to Article 10(a) of Regulation No. 893/2004 on the manufacture of medicinal products, manufacturers 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, manufacturers of active substances are registered in the European Medicines Agency database, EudraGMDP, together with a GMP certificate following the Agency’s assessment or after completion of the inspection and related follow-up.
Instructions for registering a manufacturer
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 manufactured, including the manufacturing operations
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 the manufacturing operations for which authorisation is being requested
Overview of quality documents and the main elements of the quality assurance system for the activities
Copy of written procedures for recalls
Site Master File
Copy of the diploma/certificate and CV of the qualified/responsible person
Training record of the qualified/responsible person
Registration of changes
The registration form must be completed so that the registration describes the intended changed activities for the manufacture of active substances.
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