{"id":15,"date":"2013-03-21T18:04:13","date_gmt":"2013-03-21T16:04:13","guid":{"rendered":"http:\/\/dev.laaketietokeskus.fi\/vnrwiki\/?page_id=15"},"modified":"2022-05-02T13:33:46","modified_gmt":"2022-05-02T10:33:46","slug":"please-translate-in-se-please-translate-in-fi-summaries","status":"publish","type":"page","link":"https:\/\/wiki.vnr.fi\/?page_id=15","title":{"rendered":"Country specific information \u2013 SWEDEN"},"content":{"rendered":"

Printable version of this document:
\n\"pdf\"\u00a0Vnr Country specific information of\u00a0Sweden<\/a><\/strong><\/p>\n

LIFs recommendation\u00a0\u2013 Transition from NTIN to GTIN:<\/strong>
\n\"pdf\"\u00a0English<\/a> \/ \"pdf\"\u00a0Swedish<\/a><\/strong><\/p>\n

In this document information related to the handling of article numbers in Sweden is presented.\u00a0Definitions of keywords are found in chapter 10.<\/p>\n

<\/div>\n

Nordic & National <\/span>article numbers<\/span><\/h1>\n
\n

Country specific information<\/p>\n

Sweden<\/p>\n

Version 1.5<\/p>\n

Purpose of the document<\/strong><\/p>\n

This document contains the Swedish country specific information presented in VnrWiki and will be used when there is a need to update the Swedish country specific information in VnrWiki.<\/p>\n

A new version of the document with updated information visualised with track changes should be sent to PIC, who will implement the changes in VnrWiki.<\/p>\n

Thereafter, the track changes are accepted, and the document saved to be used for the next update of the information in VnrWiki.<\/p>\n

Index
\n<\/a><\/a><\/a><\/a>Article numbers \u2013 Country specific information \u2013 Sweden_ 5<\/a><\/p>\n

1\u00a0\u00a0\u00a0\u00a0 The flow of product and article information_ 5<\/a><\/p>\n

2\u00a0\u00a0\u00a0\u00a0 Vnr \u2013 stakeholders\u2019 different needs_ 8<\/a><\/p>\n

2.1\u00a0\u00a0\u00a0\u00a0 Medical Product Agency – L\u00e4kemedelsverket (regulatory control)_ 8<\/a><\/p>\n

2.2\u00a0\u00a0\u00a0\u00a0 TLV (prices)_ 9<\/a><\/p>\n

2.3\u00a0\u00a0\u00a0\u00a0 The Swedish eHealth Agency (VARA \u2013 a national product and article register)_ 9<\/a><\/p>\n

2.4\u00a0\u00a0\u00a0\u00a0 Wholesale distributors (distribute)_ 9<\/a><\/p>\n

2.5\u00a0\u00a0\u00a0\u00a0 Health care (prescribe)_ 10<\/a><\/p>\n

2.6\u00a0\u00a0\u00a0\u00a0 Pharmacies (logistics and dispensing)_ 10<\/a><\/p>\n

3\u00a0\u00a0\u00a0\u00a0 Impact on Vnr when an article and\/or its package changes_ 11<\/a><\/p>\n

3.1\u00a0\u00a0\u00a0\u00a0 What happens when an incorrect Vnr has been saved in LiiV?_ 11<\/a><\/p>\n

3.2\u00a0\u00a0\u00a0\u00a0 Change of trade name_ 12<\/a><\/p>\n

3.3\u00a0\u00a0\u00a0\u00a0 Change of marketing authorisation holder (MAH) 13<\/a><\/p>\n

3.4\u00a0\u00a0\u00a0\u00a0 Change of package type_ 13<\/a><\/p>\n

3.5\u00a0\u00a0\u00a0\u00a0 Change of Rx \/ OTC_ 13<\/a><\/p>\n

3.6\u00a0\u00a0\u00a0\u00a0 Can old Vnrs be removed from LiiV for articles, which are not marketed?_ 14<\/a><\/p>\n

3.7\u00a0\u00a0\u00a0\u00a0 May a Vnr be reused?_ 14<\/a><\/p>\n

3.8\u00a0\u00a0\u00a0\u00a0 How is the previous Vnr handled in LiiV when a Vnr is changed?_ 14<\/a><\/p>\n

3.9\u00a0\u00a0\u00a0\u00a0 May an identical parallel imported article originating from different export countries have the same<\/em> Vnr in a country and in different countries?_ 14<\/a><\/p>\n

4\u00a0\u00a0\u00a0\u00a0 Checklists_ 15<\/a><\/p>\n

4.1\u00a0\u00a0\u00a0\u00a0 New Vnr_ 15<\/a><\/p>\n

4.2\u00a0\u00a0\u00a0\u00a0 Change of Vnr_ 15<\/a><\/p>\n

4.3\u00a0\u00a0\u00a0\u00a0 Withdrawal of Vnr_ 18<\/a><\/p>\n

5\u00a0\u00a0\u00a0\u00a0 Vnr \u2013 layout and allocation_ 19<\/a><\/p>\n

5.1\u00a0\u00a0\u00a0\u00a0 Layout of the Vnr_ 19<\/a><\/p>\n

5.2\u00a0\u00a0\u00a0\u00a0 Allocation of the Vnr_ 19<\/a><\/p>\n

6\u00a0\u00a0\u00a0\u00a0 Pricing of Nordic Article Numbers_ 19<\/a><\/p>\n

7\u00a0\u00a0\u00a0\u00a0 Use of article number series_ 20<\/a><\/p>\n

8\u00a0\u00a0\u00a0\u00a0 L\u00e4kemedelsbranschens nummern\u00e4mnd, LNN_ 22<\/a><\/p>\n

9\u00a0\u00a0\u00a0\u00a0 Contact information_ 23<\/a><\/p>\n

9.1\u00a0\u00a0\u00a0\u00a0 Sweden_ 23<\/a><\/p>\n

10\u00a0\u00a0\u00a0\u00a0\u00a0 Definitions_ 24<\/a><\/p>\n

<\/a>Article numbers \u2013 Country specific information \u2013 Sweden<\/p>\n

<\/a><\/a><\/a><\/a><\/a>1\u00a0 The flow of product and article information<\/h1>\n

The Swedish eHealth Agency has the national responsibility to compile and supply a national product and article register to the Swedish market. The purpose of the register, called VARA, is to supply the Swedish market with up to date and quality assured product and article information for the approved pharmaceuticals on the market in Sweden and consumer products within the reimbursement system.<\/p>\n

VARA is distributed to all pharmacies, veterinarian health care systems, system suppliers, statistics stakeholders and Sil, Svenska Informationstj\u00e4nster f\u00f6r L\u00e4kemedel. Sil in turn distributes the VARA information to health care actors. All health care systems should be integrated with SIL.<\/p>\n

Figure 1 shows the VARA system at the Swedish eHealth Agency and its sources. VARA daily collects and compiles updates from LiiV.<\/p>\n

\"This<\/em>
\nThe quality of data in VARA is vital, and the information in VARA is therefore updated in accordance with a well-defined input process. All changes are validated with automatic validity checks and are thereafter reviewed and approved by pharmacists before they are published once a day.<\/p>\n

It is the responsibility of the information owners, such as TLV, MPA (LV) and pharma companies to deliver quality assured information to VARA and quickly correct any deviations.<\/p>\n

Pharmacies are required to update their systems with information from VARA daily in order to be able to file prescriptions from National Medication List, NLL at the Swedish eHealth Agency.<\/p>\n

Currently Sil and health care systems are updated with VARA information approximately once a week.<\/p>\n

Figure 2 shows how dispensing systems at pharmacies use a local copy of VARA and how central systems such as the Prescription repository (National Medication List, NLL\/receptdep\u00e5 djur, RDD) and the Register of sales transactions (F\u00f6rs\u00e4ljningstransaktionsregistret, FOTA) at the Swedish eHealth Agency are directly linked to VARA. The figure schematically also shows how health care actors have access to VARA via Sil alternatively for veterinarian health care systems directly from the Swedish eHealth Agency, and how electronic prescriptions get into RR\/RRD.<\/p>\n

\"This<\/p>\n\n\n\n\n\n\n\n\n\n\n\n
Swedish<\/strong><\/td>\nEnglish<\/strong><\/td>\n<\/tr>\n
Sil<\/strong>
\nSil-databas
\nAndra k\u00e4llor<\/td>\n		Sil<\/strong>
\nSil database
\nOther sources<\/td>\n<\/tr>\n
V\u00e5rdakt\u00f6r A-B<\/strong>
\nV\u00e5rdsystem<\/td>\n		Health care actor A-B<\/strong>
\nHealth care system<\/td>\n<\/tr>\n
Veterin\u00e4rt v\u00e5rdsystem C<\/strong>
\nV\u00e5rdsystem<\/td>\n		Veterinarian health care actor C
\n<\/strong>Health care system<\/td>\n<\/tr>\n
Apoteksakt\u00f6r E-F<\/strong>
\nExpedierande system
\nAndra artiklar
\nVARA-kopia<\/td>\n		Pharmacy Actor E-F<\/strong>
\nDispensing system
\nOther articles
\nVARA (copy)<\/td>\n<\/tr>\n
Intressent D
\n<\/strong>\u00d6vrig intressent<\/td>\n		Stakeholder D<\/strong>
\nOther stakeholder<\/td>\n<\/tr>\n
F\u00f6rskrivning till NLL\/RDD<\/strong><\/td>\nPrescription <\/strong>to NLL\/RDD<\/strong><\/td>\n<\/tr>\n
Tj\u00e4nsteanrop apotek – NLL\/RDD<\/strong><\/td>\nService calls pharmacy – NLL\/RDD<\/strong><\/td>\n<\/tr>\n
Rapportering till FOTA och NLL<\/strong><\/td>\nReporting to FOTA and NLL<\/strong><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

Figure 2 VARA, pharmacies, and health care actors<\/em><\/p>\n

<\/a><\/a><\/a><\/a><\/a>2\u00a0 \u00a0Vnr \u2013 stakeholders\u2019 different needs<\/h1>\n

This chapter describes how different stakeholders use, and are dependent on, Vnrs in the handling of pharmaceuticals and reimbursed consumer products on the Swedish market.<\/p>\n

In Sweden there is not a single identification code, which provides a unique identity for all pharmaceuticals, medical devices, and consumer products. However, the Vnr has, in combination with other identification codes, a very important function in the handling of pharmaceuticals on the Swedish market.<\/p>\n

It is extremely important that manufacturers working with products on the Swedish market are aware that the Vnr is a critical attribute. It functions as an information carrier between a number of IT-systems involved in the prescription, dispensing, ordering, storage and information regarding medicines. The usage of the Vnr is therefore a matter of well-functioning management of articles as well as patient safety. In addition, electronic prescriptions as well as highly automated management systems in all parts of the distribution chain enhance the risk of fatal consequences if a Vnr is mixed or incorrect.<\/p>\n

For the distribution chain to function safely, it is important to know when and how an article should change Vnrs.<\/p>\n

An error in a Vnr may result in unexpected and serious consequences. The result of an incorrect Vnr can be that a pharmaceutical loses its identification or is identified as a completely different pharmaceutical. After the reregulation of the pharmacy market the systems of the stakeholders have become highly automated and integrated, which further increases the need for correct Vnrs for the management of pharmaceuticals to function efficiently and safely.<\/p>\n

In Sweden, the handling of Vnrs is funded through the FASS-charge and therefore there is no direct cost associated with acquiring a Vnr.<\/p>\n

The administration of the Vnr system is under responsibility of the Nordic Number Centre, (NNC)[1]<\/a>, vnr@vnr.fi<\/a>, located at Pharmaceutical Information centre Ltd. (L\u00e4\u00e4ketietokeskus Oy), Helsinki, Finland.<\/p>\n

<\/a><\/a><\/a><\/a><\/a><\/a>2.1\u00a0 Medical Product Agency – L\u00e4kemedelsverket (regulatory control)<\/h2>\n

The Medical Product Agency (L\u00e4kemedelsverket) use NPL id and NPL pack id as identification codes. Vnrs are not used by the MPA, but in LiiV there is a field for Vnr, which the responsible company adds together with other information.<\/p>\n

<\/a><\/a><\/a><\/a><\/a>2.2\u00a0 TLV (prices)<\/h2>\n

Please read TLV\u2019s document Handbok f\u00f6r f\u00f6retag vid ans\u00f6kan om subvention och pris f\u00f6r l\u00e4kemedel. <\/em>The document is available on the website of TLV: Handbok f\u00f6r f\u00f6retag vid ans\u00f6kan om subvention och pris f\u00f6r l\u00e4kemedel (tlv.se)<\/em><\/a><\/p>\n

<\/a><\/a><\/a><\/a><\/a>2.3\u00a0 The Swedish eHealth Agency (VARA \u2013 a national product and article register)<\/h2>\n

The Swedish eHealth Agency has the national responsibility to compile and provide a national product and article register to the Swedish market. The purpose of the register, called VARA, is to provide the Swedish market with up to date and quality assured product and article information for the approved pharmaceuticals on the market in Sweden and consumer products within the reimbursement system.<\/p>\n

It is the responsibility of the information owners, such as TLV, MPA (LV) and pharma companies to deliver quality assured information to VARA and quickly correct any deviations.<\/p>\n

Since information in LiiV is automatically distributed via VARA to the various stakeholders in the market, which in turn uses the information in a variety of situations and applications, it is very important that the Vnrs saved in LiiV are correct. Changes in LiiV are transferred and updated automatically in subsequent systems. Please be very careful when entering the Vnr. Notify the Swedish eHealth Agency and correct immediately if an error occurs. When the flag \u201cOn the market\u201d once has been set and saved to \u201cyes\u201d the article information will always be distributed from VARA.<\/p>\n

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

When a pharma company is about to change a specific Vnr, it is important that the change of Vnr will be synchronised with the distributor. The reason for this is to achieve time 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 LiiV, there is a risk that the pharmacies purchase orders won’t be recognised by the distributor.<\/p>\n

<\/a><\/a><\/a><\/a><\/a>2.4\u00a0 Wholesale distributors (distribute)<\/h2>\n

Currently the distribution systems of the two main distributors in the Swedish market, Oriola and Tamro, use Vnrs to identify articles.<\/p>\n

Vnrs are used throughout the whole distribution chain from pharma companies to the patient, e.g. purchase orders, inventory management and traceability according to GDP. In addition, all pharmacies currently order on Vnrs.<\/p>\n

When the same Vnr is used in several Nordic countries for an identical article where only the product information leaflet in the packages is different there are problems in the handling of the article, since it is not visible on the package for which country the package is intended. If an article is sent to the wrong country, it results in withdrawals. This problem is handled with different GTINs for the different markets.
\nPlease see more information about GTIN\/NTINs<\/a>.<\/p>\n

<\/a><\/a><\/a><\/a><\/a>2.5\u00a0 Health care (prescribe)<\/h2>\n

Currently the handling of pharmaceuticals in health care would not function without Vnrs.<\/p>\n

Most health care systems currently use Vnrs to identify pharmaceuticals when medicines are prescribed. It is therefore important that the Vnrs are updated and correct.<\/p>\n

To be able to follow the information about a pharmaceutical over time, it is important that the article history of Vnrs is complete and clear, and that as few changes as possible are made to the article.
\nPlease see more information about GTIN\/NTINs<\/a>.<\/p>\n

<\/a><\/a><\/a><\/a><\/a>2.6\u00a0 \u00a0Pharmacies (logistics and dispensing)<\/h2>\n

Vnrs are necessary for several of the processes in pharmacies. They play a central role in<\/p>\n