1. How to register a product?
* Log in to farmalogg.no.
* Select Registration in the blue menu bar and then Register new product.
* Choose the correct product group and select Register one product or Register a product line.
* Fill in all the mandatory fields marked with an astarisk.
* Fill in other fields necessary for case processing.
* Upload required documentation on the last page of the registration.
o See Documentation requirements under Guidelines (requires login), or on the last page of the registration.
2. What does Register a product line entail?
* Select Register a product line when you are going to register several products with the same product name, but with for instance different package size or strength.
* When registering a product line, some of the fields will copy to the next product that shall be registered. These are marked with yellow and can be changed if necessary.
* When registering a product line, you only need to upload the documentation one time.
* When registering a product line, all the products will come on one receipt.
* When registering a product line, it will be sent only one confirmation email once the case processing of all the products in the product line is completed.
* If the product line consists of several different product groups, each product group should be registered in an own product line.
3. How long is the case processing time?
* Normally from 1-5 working days, depending on how large workload we have.
* If the enrollment is urgent, please comment this with justification in the field Supplementary comment on the case/registration.
4. When will the product be available in Vareregisteret in the pharmacies?
* The product will be available on the date set as Marketing date.
* Vareregisteret is updated on the 1st and the 15th each month.
5. Change of article number
* It is not permitted to change the article number of already marketed/active products.
* If a product needs to change its article number, it must be registered as a new product so that the outgoing and new article numbers each have their own entry in the Article Number Register.
o Packages with outgoing and new article numbers can be sold in parallel.
o When registering a new product, you must indicate which article number/product is being replaced.
o Farmalogg will link the outgoing and new product numbers in the case processing as information to NOMA, wholesalers and pharmacies.
* In the event of an article number change, wholesalers control the status of the outgoing article number so that wholesalers and pharmacies have the opportunity to sell off existing stock.
o This means that as long as at least one of the wholesalers has the outgoing article number as active, product status will be marketed.
o When all the wholesalers have reported the outgoing article number as discontinued to Farmalogg, the product status will change to discontinued.
6. Shortage of medicinal products
* When there are supply issues for a medicinal product with marketing authorisation, NOMA can make exceptions to the requirement for marketing authorisation if the potential consequences of a shortage are considered serious. See Application for license to sell foreign packages.
* If the license applies to the sale of joint Nordic packages with the same article number as the Norwegian packages, the Norwegian article number already registered in the database is used.
o For pharmacies to be able to scan the package, the product code on the joint Nordic package must be registered to the Norwegian article number. See point 2 under Registration of new product code/barcode/GTIN.
o When you register the product code, you must upload the license from NOMA to sell the foreign package as documentation, in addition to the mock-up.
o If there is a product code on the inner package, this must also be registered. See point 3 under Registration of new product code/barcode/GTIN.
* If the permission applies to the sale of Nordic packages with a different article number than the Norwegian packages or packages from outside the Nordic region, you must apply for a national article number if it does not already exist.
o To be assigned a national article number, you must register the medicinal product as a new product and choose the product group medicinal products without marketing authorisation. Farmalogg assigns a national article number during case processing.
o As documentation, you must attach the SPC or equivalent product description from the country of origin, a mock-up of the package and the license to sell the foreign package from NOMA.
o If you want the earliest possible marketing date, indicate this in the field Additional comments to the case/registration. We have the possibility to manually expedite the marketing date in certain cases.
o Note that if a national article number has already been assigned to the same foreign package, you should not apply for a new national article number. The same package means that it has the same product name, pharmaceutical form, strength, package size, and package type, but it may, for example, have a different language on the package.
- In these cases, you register the product code on the new foreign package to the existing national article number in the same way as for joint Nordic packages, see above.
* Please note that NOMA may specify additional conditions in the license, which should therefore be included as documentation when registering a new product.
o If you have any questions regarding the registration, you must include the license when you send us an email.
* Product codes registered for foreign packages should not be canceled, even if there is no longer a shortage. There is no limit to the number of product codes registered to an article number, and it may be relevant to sell the package later. The product code may be registered to the article number even if the permission from NOMA is no longer valid.
Did you not get answer to your question? Send an email to Farmalogg.