Changes in Vnr information

Country specific information: SWEDEN, DENMARK, NORWAY

 

NOTE – All changes of an article and its package must be informed to, and confirmed with, NNC/PIC in advance.

The general rule is that the Vnr must be changed if any of the six basic criteria described under Criteria for Vnr has been changed, or no longer is valid.

In many cases it is not mandatory, but most often recommended, to change the Vnr, since it thereby will be obvious to all stakeholders that the article somehow has been changed.

Changes can easily be made for Vnrs, which never have been on the market (status Assigned) in any country. Only in very special cases and rarely can a Vnr be kept when an article or its package, which has been on a market, is changed. Usually a new Vnr is required.

It is absolutely forbidden to reuse a withdrawn Vnr for another article.

In some cases NNC may reactivate a withdrawn Vnr if the article is exactly the same and if all the information is still relevant. This can only take place after direct contact with, and decision by, NNC.

In order for NNC to take correct decisions it is important that the status of an article in each country is correct in the Vnr system. It is therefore the responsibility of the company to inform NNC about changes in the status of an article for each country.

Introduction of a new pharmaceutical product to the market

Nordic Article Numbers should be applied for as close to the marketing authorisation as possible. If the article already has a Vnr NNC still must be informed before the introduction of the article to the market.

Change in the composition of the article

If the active substance of a product is altered in any way, a new Nordic Article Number must be assigned to the article.

If the change only concerns an excipient, the Vnr does not need to be changed. However, the Vnr may be changed to mark that the article has been changed. Please contact NNC to discuss the specific situation.

Change of trade name

It is recommended that the Vnr is changed when the trade name of the product changes.

If agreed upon in advance with NNC the Vnr, in certain situations, can be maintained:

  • The article only exists in one country
  • The trade name change takes place more or less at the same time (within a few months) in all Nordic countries. If it takes longer the Vnr must be changed.

Note that the instructions for Denmark differs from the other Nordic countries, see Danish country specific information.

Note that there, for some countries, may be further country specific guidelines.

Change of marketing authorisation holder (MAH)

The same Vnr can be maintained if the MAH is changed at the same time in all Nordic countries and if the old and the new MAH agree on this. It should be noticed, that the sales statistical history moves to the new MAH together with the Vnr.

When a product changes MAH all other but withdrawn Vnrs associated with the product must be moved to the new MAH. Thereafter the Vnrs can be continuously used or changed. The status of not needed Vnrs may be changed to Withdrawn, but the Vnrs must not be directly deleted from the national product and article registers.
Please contact NNC to discuss the specific situation.

Note that there, for some countries, may be further country specific guidelines.

Change of the marketer

If all other article information remains the same, the same Vnr can be maintained. However, NNC must be informed about changes in marketer in advance.

Please note that Vnrs are found in the Vnr extranet service under marketer companies, but Vnrs belong to the MAH.

Change of pharmaceutical dosage form

NNC must be informed about all changes of the pharmaceutical dosage form.

Linguistic differences in presenting the pharmaceutical dosage form can be approved as long as the composition of the product is the same and the term used complies with the EU Standard Terms. However, NNC must be informed in advance for confirmation.

Change of strength

A change in strength always results in a new article that needs a new Vnr.

Change of pack size

The pack size must be the same in all concerned Nordic countries where the same Vnr is used, for instance number of tablets or ml.

Change of package type

In most cases the Vnr needs to be changed.

Please contact NNC for further information, when considering changing package type or package material.

Note that there, for some countries, may be further country specific guidelines.

Change of Rx / OTC

An OTC-package is by definition a different package compared to the corresponding Rx-package and must therefore carry different Vnrs if both packages are on the market at the same time.

Switch Rx -> OTC

If a switch is made from RX to OTC the Vnr should be changed, since the requirements for package text, package leaflet etc. differ.

Switch OTC -> Rx

If a switch is made from OTC to Rx the Vnr can be maintained.

Note that the instructions for Norway differs from the other Nordic countries.

Withdrawal of a Vnr

A Vnr can have the status Withdrawn in one or several countries.

It is absolutely forbidden to reuse a withdrawn Vnr.

Companies can notify Vnr withdrawals at any time by using the withdrawal function in the Vnr extranet service.

Note that there, for some countries, may be further country specific guidelines.

 

Country specific information: SWEDEN, DENMARK, NORWAY