Registration of batch certificate for medicines with marketing authorisation (MA)

1. How to register batch certificate?
    * Log in to farmalogg.no.
    * Select Batch overview in the blue menu line and next Register new batch certificate at the middle of the page.
    * Fill in the following fields:
       Batch number                      Specified in the certificate and on the package
       Expiry date for the batch  
Specified in the certificate and on the package
       Release date                       
The date the QP has released the batch for sale for the Norwegian market
    * Add the product the batch number applies for.
       - If the batch number applies for several article numbers/packages and these have the same expiry date and release date, all of the article numbers/packages can be added to the same registration.
       - If the batch number applies for several batches with different release dates and/or expiry dates and these have their own certificate, all these certificates must be uploaded to the same registration. It is not possible to register the same batch number and article number several times. 
    * 
It shall only be registered batch certificates for medicines with MA.
       Status must be Processed, Marketed or To be discontinued.
       The product must be listed to the company you are logged in on behalf of.
    * Upload the batch certificate(s).
       If the batch number applies for several article numbers/packages and these have their own certificate, all these certificates should be uploaded.

2. What does the error message Invalid article number mean?
    * The selected product is not marketed in Norway and is registered as a medicine without MA. It is only possible to register batch certificates for medicines with MA.
    * The selected product is listed to another marketer/local representative than the company you are logged in on behalf of.
    * The selected product is not enrolled, has status In progress or status Discontinued.

3. Why is it not possible to upload the batch certificate?
    * The file name contains special characters or double dots. Remove the special characters or one of the dots from the file name and try to upload the document once more.
    * Make sure that you use the web browser Internet Explorer v.10 or newer version, or newer version of Firefox or Chrome.

4. 
What if the batch is released for another country?
    * Batch certificate for foreign packs shall be registered at farmalogg.no if the NOMA has given permission to sell foreign packs due to medicine shortage.
    * This applies only when the the foreign pack is to be sold on the existing Nordic article number already registered at farmalogg.no.
    * The permission from the NOMA shall not be registered at farmalogg.no, but should be sent directly to the wholesalers who forwards information to their pharmacies.
    * Please note that you should not register batch certificates for foreign packs that have been assigned national article numbers by Farmalogg.


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

 

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