The document The serialisation of Nordic packages, country specific requirements has been updated. The example for the EXP date in the EEA licence plate picture has been amended.
A small update in the Nordic Article Number instruction booklet. Section 5.7 made clearer and the notification regarding the need of different GTINs added.
The document The serialisation of Nordic packages, country specific requirements has been updated.
Two new documents are published under the section Transition from NTIN to GTIN.
The document The serialisation of Nordic packages, country specific requirements was first prepared by LIF in Sweden and then revised in co-operation with the other Nordic countries.
Norway has also prepared a document Implementation of 2D data matrix in Norway.
Both documents are intended to help the pharma companies when planning the transition from NTIN to GTIN and the serialisation process in relation to the FMD.
The Vnr statistics document 2016 is published here in VnrWiki.
The annually published Vnr statistics document is soon to be published here in VnrWiki. Looking at the data, the year 2016 was very similar to 2015. 31.12.2016 there were 64 959 active Vnrs for 17 456 trade names, belonging to 1 290 different MAHs.
The Vnr extranet service (https://vnr.fi), that companies use for ordering new Vnrs and where they can see their real-time Vnr situation in all Nordic countries 24/7, had 1 700 registered users from 540 different companies at the end of the year.
Barcodes in Norway
The country specific information regarding barcodes in Norway has been updated.
(see Barcode, country specific information Norway)
A new section in VnrWiki: From NTIN to GTIN
The coding of medicines changes because of the requirements of the Falsified Medicines directive. Pharma companies have to make sure that the product codes are unique (GTIN or unique NTIN).
The codes are extremely important, because all information used in different IT-systems in health care, pharmacies, wholesalers, robots etc. are based on codes that link to the correct information to be shown for users.
To help and support pharma companies we have prepared guidance about GTINs in pharmaceuticals. The guidance has been produced together with Nordic Vnr co-operation group and GS1. The guidance documents are now published here in VnrWiki in the new section “From NTIN to GTIN”
New rules governing medicine packages in Denmark
The Danish Medicines Agency has issued a new guideline on variations to marketing authorizations for medicinal products and a new executive order on product numbers for medicinal products.
With the new guideline, the Danish Medicines Agency will ease the administrative and financial burden of implementing certain administrative variations. For example, if the MA changes ownership or other changes are made to the company information.
Note that the product number requirement is also eased for multi packages and large packages
(see Changes in Vnr information, Country specific information Denmark)
Barcodes in Finland
The country specific information regarding barcodes in Finland has been updated.
(see Barcode, country specific information Finland)