Forms

An overview

Categories:

Forms for licensing of medicines

Application form for parallel import docx, 58 kb Licensing of Medicines

Application for importation, distribution and sale of homeopathic medicine pdf, 57 kb Licensing of Medicines

Application for reduction of annual fees doc, 359 kb Licensing of Medicines

Application for withdrawal of MA or removal of information from the drug catalogue doc, 125 kb Licensing of Medicines

Request for publication of information in the drug catalogue and the price list docx, 128 kb Licensing of Medicines

Request for republication in the Medicine Price Catalogue docx, 123 kb Licensing of Medicines

Application form for new proposed (invented) product names docx, 43 kb Licensing of Medicines

Forms for pharmacies

Application for pharmacy license, to start a new pharmacy doc, 60 kb Pharmacies

Application for pharmacy license, to take over a operating pharmacy (in Icelandic) doc, 62 kb Pharmacies

Application for operating license for pharmacy doc, 40 kb Pharmacies

Application for reducing pharmacy opening hours (in Icelandic) doc, 56 kb Pharmacies

Application to temporarily work as an assistant pharmacist (in Icelandic) doc, 54 kb Pharmacies

Forms for importation, manufacturing and distribution of medicinal products

Application for license to import and distribute medicinal products (in Icelandic) docx, 63 kb Importation, manufacturing and distribution

Application for license to manufacture medicinal products (in Icelandic) docx, 61 kb Importation, manufacturing and distribution

Application for a Certificate of Pharmaceutical Product (Type A) Importation, manufacturing and distribution

Forms for controlled substances

Application for importation of controlled substances (in Icelandic) doc, 1339 kb Controlled Substances

Forms for clinical trials

Signature form (in Icelandic) doc, 49 kb Clinical Trials

Checklist IMP with marketing authorisation in EEA (May 2011) pdf, 141 kb Clinical Trials

Checklist IMP without marketing authorisation in EEA (May 2011) pdf, 149 kb Clinical Trials

Forms for veterinary medicines

Usage report for controlled substances for animals pdf, 60 kb Veterinary Medicines

Forms for medical devices

Notification for owner/user of incident docx, 44 kb Medical Devices

Manufacturer's incident report (only works in Internet Explorer) Medical Devices

Notification for owner/user of incident for implantable medical device docx, 47 kb Medical Devices

Serious adverse event during clinical trial reporting form Medical Devices

Medical device registration form doc, 76 kb Medical Devices

Medical device registration form for producers doc, 79 kb Medical Devices

Clinical investigation - application form under Medical Device Regulation Medical Devices

Form for reporting shortage

Reporting medicine shortage docx, 49 kb Medicine Shortage

Form for scientific advice

Application form for scientific advice doc, 86 kb Scientific advice

Forms for wholesale price applications and reimbursement

Application for wholesale price xls, 72 kb Wholesale price and reimbursement

Application for wholesale price - hospital medicines xls, 72 kb Wholesale price and reimbursement

Application for general reimbursement xls, 71 kb Wholesale price and reimbursement

Application for Reimbursement for Specialty Care Highcost medicine (SCHCM) – New indication docx, 252 kb Wholesale price and reimbursement

Application for Reimbursement for Specialty Care High-cost Medicine (SCHCM) – New Pharmaceutical Form or New Strength docx, 248 kb Wholesale price and reimbursement

Application for Reimbursement for Specialty care high-cost medicine (SCHCM) – Biosimilar or Generic drugs docx, 245 kb Wholesale price and reimbursement

Compassionate Use (CU) docx, 235 kb Wholesale price and reimbursement

Request for publication in the Price Catalogue and the Product Catalogue docx, 127 kb Wholesale price and reimbursement

Request for re-publication in the Price Catalogue docx, 123 kb Wholesale price and reimbursement

Form for publishing in Medicinal Product Catalogue

Application for publishing in "Medicinal Price Catalogue" and "Medicinal Product Catalogue" docx, 127 kb Medicinal Product Catalogue

Forms for importation of medicinal products for personal use

Application for exemption from regulation on importation by individuals of medicinal products , 0 kb Importation of medicinal products for personal use

Enquiry regarding importation of medicinal products for personal use , 0 kb Importation of medicinal products for personal use

Application form for educational materials

Request form for review of educational materials docx, 62 kb

Last updated: September 23, 2024
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