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Request for publication of information in the Drug Catalogue and the Price List1 Product name Strength Pharmaceutical form Package Nordic Article Number (Vnr) Pack size Package type Please tick the relevant box: New product New pack size New name of medicinal product New pharmaceutical form New packaging type New Nordic article number New strength Please confirm that the following conditions are fulfilled, by ticking the relevant boxes: An Icelandic marketing authorisation has been issued. Mock-ups of primary and secondary packaging material – receipt confirmed by the Icelandic Medicines Agency. The packages which will be marketed are in compliance with the mock-ups of the primary and secondary packaging material. Approved price and reimbursement, if relevant. Not relevant (OTC products for human use) Conditions according to Annex II (B) are fulfilled2 Annex II (B) is not relevant Confirmation of stock. A medicinal product which can be assumed to feature on the substitution list or expected to compete with comparable products on the market must be in stock at a local wholesaler before the 20th day of the month and ready for delivery to pharmacies by the end of that month. Should the product not be in stock at a local wholesaler on the 20th day of the month, this must be reported to the Icelandic Medicines Agency ([email protected]) and the Icelandic Medicine Pricing and Reimbursement Committee ([email protected]). This will delay the publication by one month, presuming a new request for publication will be submitted in time. Date 1 2 Name of the person requesting a product to be published in the Drug Catalogue and the Price List Completed application form shall be sent by e-mail to [email protected] and [email protected] Conditions for marketing 5 January 2012