Forms

An overview

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All forms
Licensing of Medicines
Pharmacies
Importation, manufacturing and distribution
Controlled Substances
Clinical Trials
Veterinary Medicines
Medical Devices
Educational Materials
Drug Shortage
Scientific advice
Wholesale price and reimbursement
Medicinal Product Catalogue
Specialty care medicines
Importation of medicinal products for personal use

Forms for licensing of medicines

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

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

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

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

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

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

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

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Forms for pharmacies

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

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

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Application for operating license for pharmacy doc, 40 kb Pharmacies

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

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

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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

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

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

Open

Forms for controlled substances

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

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Forms for clinical trials

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

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

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

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Forms for veterinary medicines

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

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Forms for medical devices

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

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

Open

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

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Serious adverse event during clinical trial reporting form Medical Devices

Open

Medical device registration form doc, 76 kb Medical Devices

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

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Clinical investigation - application form under Medical Device Regulation Medical Devices

Open

Form for reporting shortage

Reporting medicine shortage docx, 49 kb Medicine Shortage

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Form for scientific advice

Application form for scientific advice doc, 86 kb Scientific advice

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Forms for wholesale price applications and reimbursement

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

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

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

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

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

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

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

Download

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

Download

Form for publishing in Medicinal Product Catalogue

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

Download

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

Download

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Forms

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

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

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