19.6.2017, versin 5 Actin plan: serialisatin f Nrdic packages fcus n Prduct Cdes The aim f this dcument is t help pharma cmpanies t prepare fr prduct cde changes and t be able t maintain prduct cdes in an efficient manner als after the launch f everificatin. This dcument has been prepared by LIF Sweden and verified by all Nrdic cuntries. If yu have change requests t this dcument, please send them t: vnr@vnr.fi. The safety features required by the Falsified Medicines Directive (everificatin) will cnsist f a unique package identity carried by a 2D Data Matrix cmbined with tamper evidence. The 2D Data Matrix carries the fllwing elements Prduct cde (GTIN r unique NTIN) Unique serial number (randmized) fr every single physical package Batch number Expiry date EEA license plate: A 2D Data Matrix is printed n the pack tgether with the same infrmatin in human readable frmat # GTIN = Glbal Trade Item Number NTIN = Natinal Trade Item Number GTIN 1 = GTIN r Unique NTIN in this dcument Linear barcde = 1D cde carrier, which can hld either NTIN r GTIN 2D Data matrix = 2D cde carrier, which n the secndary pack, hlds Prduct cde (GTIN 1 ), Serial n, Batch n and Expiry date. Vnr = Nrdic Article Number, nt included in GTIN. Linkage between Vnr and GTIN 1 s is maintained in natinal data systems. EEA = Eurpean Ecnmic Area QRD = The Eurpean Medicines Agency's Wrking Grup n Quality Review f Dcuments Hard cut = A cut-ff date (ld packages need t be recalled) Cuntry requirements during pre-serialisatin phase and pst-serialisatin phase 1 GTIN (Glbal Trade Item Number) in this dcument means GTIN/Unique NTIN *Mre infrmatin abut abbreviatins http://www.ema.eurpa.eu/dcs/en_gb/dcument_library/regulatry_and_prcedural_guideline/2009/10/wc5 00004426.pdf # General infrmatin abut labelling, https://ec.eurpa.eu/health/sites/health/files/files/eudralex/vl- 2/2016_12_packaging_guidelines_revisin_14_4.pdf 1
General principles One GTIN 1 per secndary pack per stck keeping unit (SKU). DENMARK Pssibility: Keep current Vnr, keep current unique NTIN. Hard cut is needed at the mment when changing frm NTIN t GTIN 1 n packs (hard cut: cut-ff date, ld packages need t be recalled). Pharmacy systems hwever can NOT handle tw r mre GTIN 1 s fr the same Vnr at the mment. It is expected, that there will be a transitin phase, where there might be different slutins r wrkarunds at the pharmacies. It is expected, that the timeframe fr this transitin phase will be during Q2/Q3 2017. The legislatin in Denmark allws tw prduct cde carriers i.e. linear barcde / 2D Data Matrix n the same pack. The Danish Medicines Agency (DKMA) in Denmark has cnfirmed, that it is allwed t have a NTIN and a GTIN cntaining different number sequences (=prduct cde) n the secndary packaging. N DKMA submissin r apprval needed fr change frm NTIN t GTIN 1. Submissin t DKMAnet is needed if the Vnr is changed. Different GTIN 1 needed n the primary pack than n secndary pack (Amgrs in DK). N need t add a linear barcde / 2D Data Matrix n the primary packs fr ther cuntries. Please nte, that linear barcde n the primary pack will nt be affected by the serialisatin prject. GTIN change n the primary pack shuld be reprted t Amgrs. As nted abve, linear barcdes n the primary pack is nt part f the serialisatin prject. If a cmpany uses NTIN in the 2D Data Matrix, the NTIN shuld be unique and it shuld fllw the same rules fr changing as a GTIN. The unique NTIN must have been assigned befre February 9, 2019, as n new NTINs are assigned after this date. This means that the use f NTINs will diminish Please als see table n page 5. FINLAND N need t change Vnrs when changing frm NTIN t GTIN 1. N hard cut is needed when changing frm NTIN t GTIN 1 n packs (hard cut: cut-ff date, ld packages need t be recalled). Infrm new GTIN 1 s and changes f GTIN 1 s in the Vnr Service (can be dne at any time). Prduct cdes are delivered t the supply chain actrs frm the Vnr service. Many different GTIN 1 s are allwed fr the same Vnr in the data system at the same time. This is a ne-t-many relatin. N need fr Finnish Medicines Agency s (Fimea) submissin r apprval (if nly the prduct cde is changed). If the layut is changed, an Article 61(3) ntificatin needs t be submitted and apprved (3 mnths lead time). N need fr labelling texts fr natinally apprved prducts in Finland. Mck-ups are sufficient. 2
The Finnish Medicines Agency (Fimea) has added guidance n Intrductin f safety features n their website, e.g. when a ntificatin shuld be submitted fr an apprval http://www.fimea.fi/web/en/marketing_authrisatins/safety-features If a cmpany uses NTIN in the 2D Data Matrix, the NTIN shuld be unique and it shuld fllw the same rules fr changing as a GTIN. The unique NTIN must have been assigned befre February 9, 2019, as n new NTINs are assigned after this date. This means that the use f NTINs will diminish Please als see table n page 5. ICELAND N need t change Vnrs when changing frm NTIN t GTIN 1. Check where t infrm prduct cde changes. Tw different prduct cde carriers i.e. linear barcde / 2D Data Matrix are allwed n the packs at the same time (the pharmacies rder primarily n Vnrs). The prduct cde carriers must have the same cntent i.e. prduct cde. Submissin t Icelandic Medicines Agency needed fr infrmatin accrding t nrmal practice. If a cmpany uses NTIN in the 2D Data Matrix, the NTIN shuld be unique and it shuld fllw the same rules fr changing as a GTIN. The unique NTIN must have been assigned befre February 9, 2019, as n new NTINs are assigned after this date. This means that the use f NTINs will diminish Please als see table n page 5. NORWAY Backgrund: In 2017 Nrwegian IT systems are based n ne Vnr linked t ne prduct cde (linear barcde). The linear barcde is used by whlesalers and pharmacies as an identifier in the physical handling f the prduct in many different prcesses and are vital fr crrect dispensing. It is pssible t use either a NTIN r a GTIN 1, but the data systems are nt able t manage the transfer f ne cde (e.g. NTIN) t anther cde (e.g. GTIN) withut manual changes (by Farmalgg, the whlesalers and the pharmacies) and crrespnding risks and wrklad. The prblem is nt the intrductin f GTIN but a seamless handling f mre than ne prduct cde per Vnr. If NTIN is changed t GTIN in 2017, a new Vnr is required. N hard cut is needed (hard cut: cut-ff date, ld packages need t be recalled). The new Vnr must be enrlled in Farmalgg as substitutinal Vnr. The sales f the ld Vnr will cntinue until last pack is sld by the whlesaler. The sales will be transferred t the new Vnr when each whlesaler is ut f stck f the ld Vnr. When all whlesalers are ut f stck, the ld Vnr will be remved frm the register. Any new pack (Vnr) may have a GTIN. Changing NTIN t GTIN n a marketed pack (Vnr) shuld be avided until this can be handled by the data system. This change will ccur 1 Jan 2018. Frm 1 Jan 2018, new prduct cdes may be added t the data system by the pharma cmpanies. This functinality will be added n Farmalggs websites, VareWeb. An artwrk pdf must als be submitted at the website. If NTIN is changed t GTIN after January 1, 2018, several different prduct cdes are allwed in the data systems fr the same Vnr (ne-t-many relatin). 3
Packs released t the Nrwegian market befre 9 Feb 2019 must have a linear barcde, and may have 2D Data Matrix. Packs released t the Nrwegian market after 9 Feb 2019 must have 2D Data Matrix and must nt have linear barcde. Cmpanies wh need time t remve the linear barcde after 9 Feb 2019 shuld agree this with the Nrwegian Medicines Agency. If the layut f artwrk is changed due t the intrductin f 2D Data Matrix, an Article 61(3) ntificatin must be submitted t the Nrwegian Medicines Agency. If GTIN is included n the primary pack, it must be different t the GTIN n the secndary pack. Frm the beginning f 2018, prduct cdes fr primary packs may be added t the data system by the pharma cmpanies. This functinality will be added n Farmalggs website, VareWeb. An artwrk pdf must als be submitted at the website. If a phama cmpany uses NTIN in the 2D Data Matrix, the NTIN shuld be unique and it shuld fllw the same rules fr changing as a GTIN. The unique NTIN must have been assigned befre February 9, 2019, as n new NTINs are assigned after this date. This means that the use f NTINs will diminish Please als see table n page 5. SWEDEN N need t change Vnrs when changing frm NTIN t GTIN 1. N hard cut is needed when changing frm NTIN t GTIN 1 n packs (hard cut: cut-ff date, ld packages need t be recalled). Change NTIN t GTIN 1 by adding the new prduct cde in Leverantörernas infrmatin i VARA (LiiV). Many different GTIN 1 s are allwed fr the same Vnr in the data system at the same time (prduct cdes are just added in LiiV and the VARA-file stres them as previus/histrical prduct cdes). This is a ne-t-many relatin. If nly GTIN 1 is changed n ntificatin/variatin needed. If the layut is changed, an Article 61(3) ntificatin needs t be submitted and apprved (3 mnths lead time). T update labelling: ntificatin fr infrmatin nly r an Article 61(3) ntificatin is needed Please nte! A labelling text needs t be created fr all natinal packs that d nt have a labelling text. https://lakemedelsverket.se/malgrupp/fretag/lakemedel/nya-gdkannanden-andringar-chfrnyelser/krav-pa-sakerhetsdetaljer-pa-lakemedelsfrpackningar/) If a cmpany uses NTIN in the 2D Data Matrix, the NTIN shuld be unique and it shuld fllw the same rules fr changing as a GTIN. The unique NTIN must have been assigned befre February 9, 2019, as n new NTINs are assigned after this date. This means that the use f NTINs will diminish Please als see table n page 5. 4
Cuntry requirements regarding changes frm NTIN t GTIN 1 DK FI IS NO SE New Vnr required N* N N Hard cut required (cut-ff date, ld packages need t be recalled) when n change f Vnr, nly change f NTIN t GTIN 1 Hard cut required (cut-ff date, ld packages need t be recalled) when change f Vnr + change f NTIN t GTIN 1 Natinal data system updates required (change NTIN t GTIN 1 ) Many different prduct cdes (GTIN 1 s) fr the same Vnr can be handled by the natinal data system (ne-t-many relatin) Tw different prduct cde carriers (linear barcde and 2D Data Matrix) with the same GTIN 1 are allwed t be printed n the secndary pack at the same time Art 61(3) needed if layut change Infrmatin frm side/bttm panel can be deleted withut an Article 61(3), if the same text is already written smewhere else Natinal cmpetent authrity ntificatin including mck-up required fr change in barcde, Vnr r 2D Data Matrix Labeling text (QRD) required fr natinally apprved prducts *Fr further infrmatin see cuntry specific text abve. * at the mment N N in 2017 N frm 2018 * in 2017 N frm 2018 * N N N N Whlesaler N* (nt fr the same Vnr) at the mment PIC Will be updated later Farmalgg N in 2017 in 2018 N N LiiV N, if there is an apprved variatin N N N N N N (all updated artwrks need t be submitted) Nt knwn yet N N 5
Fr mre infrmatin regarding everificatin, see VnrWiki r cntact: DK: nvn@dli.dk FI: inf@laakevarmennus.fi IS: Benedikt Haukssn, benedikt@gs1.is NO: pst@nmvec.n SE: everifikatin@lif.se 6