SE: Changes in Vnr information

For the common Nordic guidelines on changes, see Vnr – Nordic instruction booklet, chapter 6. Listed below is additional country specific information for Sweden on how a change in an article and/or its package should be handled. Any questions can be directed to eHälsomyndigheten registrator@ehalsomyndigheten.se

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 in the Vnr – Instruction booklet, chapter 5, has been changed, or no longer is valid.

In many cases it is not mandatory, but most often recommended, to change the Vnr when other criteria than the six basic changes. By changing Vnr it will be obvious to all stakeholders that a change has been made to the article.

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.

Pharmaceutical companies have a responsibility to always inform about changes in trade name, marketing authorisation holder, and Vnr to all pharmacies, see chapter 9 Contact information.

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

Please also read TLV’s document Information om ändringar i NPL som kan beröra subvention av läkemedel. The document is available on the website of TLV:  http://www.tlv.se/lakemedel/ansok-om-pris-eller-subvention/information-om-andringar-i-nationellt-produktregister-for-lakemedel-npl/

3.1 What happens when an incorrect Vnr has been saved in NPL?

Since information in NPL is automatically distributed via VARA to the various stakeholders in the market, which in turn uses the information in a variety of situations and systems, it is very important that the Vnrs saved in NPL are correct. Changes in NPL are transferred and updated automatically in subsequent systems. Please be very careful when entering the Vnr. Notify eHälsomyndigheten and correct immediately if an error occurs. When the flag “On the market” once has been set and saved to “yes” the article information will always be distributed from VARA.

It takes two business days until a change in NPL is available in the dispensing systems. In health care systems it takes approximately 1-2 weeks before the updated information becomes available to prescribers. Information in FASS.se is updated from NPL several times a day. See Chapter 2, Flow of product and article information.

If an incorrect Vnr has been saved in NPL, and it is discovered later, prescription on the Vnr may have occurred. In such a situation – always contact eHälsomyndigheten to discuss how the information should be handled. It is very important not to delete, edit or otherwise modify the incorrect information without first consulting with eHälsomyndigheten, since it can have major consequences in subsequent systems.

When a pharma company is about to change a specific Vnr, it is important to make the change in NPL a couple of days before the new packages are available at the distributor. The reason for this is to synchronize the change of Vnr between the pharmacies and the distributor in order to maintain the whole distribution chain. If the change of Vnr is done too early or too late in NPL, there is a risk that the pharmacies purchase orders won’t be recognized by the distributor.

3.2 Change of trade name

It is recommended that the Vnr is changed when the trade name of the product changes. It will thereby be obvious to all stakeholders that the article somehow has been changed.

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.

In cases when a Vnr is to be changed, packs with different trade names but with the same Vnr can be marketed in Sweden during a transition period (one month), when agreed with the MPA (LV).

If a company wants a longer period of parallel sale than a month it must be discussed and approved by the MPA contact person who administers the name change. A longer period is in principle never accepted unless it is a very small change, for instance that the suffix of “vet” is added to, or removed from, a vet. trade name.

For pharmaceuticals with generic names longer parallel sales can, in certain cases, be accepted.

The pharmaceutical company has a responsibility to inform all pharmacies about the change of a Vnr.

3.3 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 may not be deleted from NPL.

When a Vnr is withdrawn there is no longer a cost associated with the Vnr. In Sweden, the handling of Vnrs is funded through the FASS-charge and therefore there is no direct cost associated with Vnrs.

Please contact NNC to discuss the specific situation.

The pharmaceutical company has a responsibility to inform about the change of Vnr to all pharmacies.

3.4 Change of package type

In most cases the Vnr needs to be changed. Please contact eHälsomyndigheten and/or NNC when considering changing package type or package material. A new package gets a new NPL pack id.

A change of NPL pack ID affects the price in the reimbursement system. If the old package was reimbursed, the company needs to send a new application for reimbursement for the new package to TLV. Information regarding the application procedure can be found in TLV’s document Information om ändringar i NPL som kan beröra subvention av läkemedel. The document is available on the website of TLV: http://www.tlv.se/lakemedel/ansok-om-pris-eller-subvention/information-om-andringar-i-nationellt-produktregister-for-lakemedel-npl/

If a company, without applying for price within the reimbursement system and getting the price approved by TLV, moves a Vnr in NPL to a new NPL pack id, the price within the reimbursement system will not automatically be updated. This means that the package will be handled as if it is not reimbursed in the systems of the pharmacies.

In cases when a Vnr is not changed packs with different package type, but with the same Vnr, can be marketed in Sweden during a transition period (one month), when agreed with the MPA (LV).

3.5 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.

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

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

3.6 Can old Vnrs be removed from NPL for articles, which are not marketed?

Once an article has been set as “On the market = Yes” in NPL the specific Vnr of that article may not be removed / blanked out in NPL. Sales transactions are linked to the Vnrs in a many systems, such as receptdepån, läkemedelsförteckningen, and statistical systems within and outside eHälsomyndigheten. To mark a change for an article that is not sold, for instance when an article has been passed to another MAH, it is permissible to acquire a new Vnr, see Vnr – Nordic instruction booklet, chapter 3, Application for Nordic Article Number.

In Sweden, the handling of Vnr is funded through the FASS-charge and there is therefore no economic reason to refrain from acquiring a new Vnr.

3.7 May a Vnr be reused?

It is absolutely forbidden to reuse a Vnr for another article. An article, which has been prescribed and dispensed, is registered with the Vnr in a number of systems, e.g. receptregistret, läkemedelsförteckningen, statistics, distribution systems, order and supply systems, article history and invoicing.

For correct historical handling the Vnr must remain even though the article is not marketed.

If a company reuses a Vnr and already has printed packages, these packages may not under any circumstances be distributed on the Swedish market! The company must acquire a new Vnr, and thereafter print new packages.

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.

3.8 How is the previous Vnr handled in NPL when a Vnr is changed?

When changing a Vnr in NPL, the previous Vnr should always be transferred to the field “Previous item number”.

The previous Vnr will be saved in VARA together with the new one. This makes it possible for the pharmacies to sell both the old and the new package simultaneously.

3.9 May an identical parallel imported article originating from different export countries have the same Vnr in a country and in different countries?

Identical parallel imported pharmaceuticals originating from different export countries should have the same Nordic Article Number in a country.

If they fulfil the conditions for common Nordic packages they could have the same Vnr in the different Nordic countries despite differing MT-numbers.