SE: Checklists

Application for a Nordic Article Number should be made when the MAH knows which packages will be marketed and really need Vnrs.

Technically Vnrs can be applied for at any time. However, a Vnr should be used on the market within three years. Otherwise the status of the Vnr will be changed to Withdrawn.

Six basic criteria are mandatory and need to be met equally in all countries concerned if a Vnr is to be used in more than one country.

Order Vnr:  https://vnr.fi

Application for Vnr:
Vnr – Nordic instruction booklet – chapter 3

Status of Vnr:
Vnr – Nordic instruction booklet – chapter 4

Criteria for Vnr:
Vnr – Nordic instruction booklet – chapter 5

Changes can easily be made for articles and 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.

All changes of an article and its package must be informed to, and confirmed with, NNC/PIC in advance.
Six basic criteria are mandatory and need to be met equally in all countries concerned if a Nordic Article Number is to be used in more than one country.

Contact Apotekens Service and/or NNC/PIC to discuss if the Vnr should/ought to be changed when an article or its package is changed.

Order Vnr: https://vnr.fi

Pharmaceutical companies have a responsibility always to inform about changes in trade name, MAH, and Vnr to all pharmacies.

Send a mail to TLV with information about which Vnr is changed, to which number it is changed and which NPL pack id it has. The mail should be sent to: registrator@tlv.se

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

Vnr – Nordic instruction booklet – chapter 6

Swedish guidelines – chapter 3

TLV information:
Information om ändringar i NPL som kan beröra subvention av läkemedel.

http://www.tlv.se/lakemedel/ansok-om-pris-eller-subvention/information-om-andringar-i-nationellt-produktregister-for-lakemedel-npl/

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.

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) according to a routine at the MPA (LV).

See ”Todo” for ”1. Change Vnr?” above.

Vnr – Nordic instruction booklet – chapter 6.3

Swedish guidelines – chapter 3.2

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 Vnr may not be deleted from NPL.

Please contact NNC to discuss the specific situation.

See ”Todo” for ”1. Change Vnr?” above.

Vnr – Nordic instruction booklet – chapter 6.4

Swedish guidelines – chapter 3.3

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 change is made from OTC to Rx the Vnr can be maintained.

See ”Todo” for ”1. Change Vnr?” above.

Vnr – Nordic instruction booklet – chapter 6.10

Swedish guidelines – chapter 3.5

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.

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.

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.

Please contact eHälsomyndigheten and/or NNC when considering changing package type or package material.

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/

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) according to a routine at the MPA (LV).

See ”Todo” for ”1. Change Vnr?” above.

Vnr – Nordic instruction booklet – chapter 6.9

Swedish guidelines – chapter 3.4

A withdrawal of an article/product is a permanent action.

When the withdrawal date has passed the pharmaceutical or the article will disappear automatically from the reimbursement system and is no longer shown in the price- and decision databases of TLV.

Contact MPA (LV) who registers a date of withdrawal in NPL, either for the product or an article.

Inform NNC/PIC that the article/product has been withdrawn in Sweden.

Vnr – Nordic instruction booklet – chapter 6.11

A Vnr withdrawal can be notified at any time by using the withdrawal function in the Vnr extranet service.

Notify by using the Vnr extranet service: https://vnr.fi

Vnr – Nordic instruction booklet – chapter 4.3

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

A company, which reuses a Vnr and already has printed packages, may not under any circumstances distribute these packages on the Swedish market!

This means that the company must acquire a new Vnr, and thereafter print new packages.

Swedish guidelines – chapter 3.7