Enrollment of new product

1. How to register a product?
    * Log in to farmalogg.no.
    * Select Registration in the blue menu line and next Register new product.
    * Select correct product group and select Register one product or Register a product line.
    * Complete all the mandatory fields marked with a star.
    * Complete other fields if this is necessary for the case processing.
    * Upload required documentation 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 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. Shortage of medicinal products
    * NOMA can make exceptions to the requirement of a Norwegian marketing authorisation when marketing interruption consequences would affect public health, see further information here.
    * If the license applies to foreign packages, this is registered as a new product at farmalogg.no, choose the product group
medicines without marketing authorisation. Farmalogg assigns a national article number (= vnr only for use in Norway) in case processing.
    * If the license applies to common Nordic packages with the same Nordic article number as the Norwegian packages, there is normally no need to assign a national article number. In these cases, you must register the product code/GTIN for the common Nordic pack to the existing article number at farmalogg.no.
    * If the enrollment (registration) is urgent, please comment this with justification in the field Supplementary comment on the case/registration.


Did you not get answer to your question? Send an email to Farmalogg.

 

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