Forms
An overview
Forms for Licencing of Medicines
- Application form for marketing authorisations
- Application for renewal of a marketing authorisation
- Application for variation to a marketing authorisation
- Application form for parallel import
- Application for importation, distribution and sale of homeopathic medicine
- Application for reduction of annual fees
- Application for withdrawal of MA or deletion of information from the drug catalogue
- Request for publication of information in the drug catalogue and the price list
- Application form for new proposed (invented) product names
Forms for Pharmacies
- Application for pharmacy licence, to start a new pharmacy
- Application for pharmacy licence, to take over a operating pharmacy (in Icelandic)
- Application for operating licence for pharmacy
- Application for reducing opening hours of a pharmacy (in Icelandic)
- Application to temporarily work as an assistant pharmacist (in Icelandic)
Forms for importation, manufacturing and distribution of medicinal products
- Application for licence to import and distribute medicinal products (in Icelandic)
- Application for licence to manufacture medicinal products (in Icelandic)
- Application for a Certificate of Pharmaceutical Product
Forms for Classification/assessment of a product
Forms for controlled substances
Forms for Clinical Trials
- Signature form (in Icelandic)
- Checklist IMP with marketing authorisation in EEA (May 2011)
- Checklist IMP without marketing authoristation in EEA (May 2011)
Forms for veterinary medicines
Forms for Medical Devices
- Manufacturer's incident report (only works in Internet Explorer)
- Registration form for medical devices
- Registration form for producers