Download dd - Lyfjastofnun

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