National Code Number Barcode Last Update – 05/01/2016 CONTENTS INDEX INTRODUCTION NATIONAL CODE NUMBER 1. Description 2. Overview of coded series APPLICATION FOR NATIONAL CODE NUMBER NOTIFICATION OF CHANGES 1. Changes relating to coded products 2. Other changes relating to the company or product THE BARCODE APPLICATIONS 1. List of databases published by the Belgian Pharmaceutical Association, and which use the CNK as means of identification of products A. Prices B. Scientific database 2. Other applications A. The use of barcodes B. Use in the pharmacy C. Use in the hospital pharmacy D. For distributors and manufacturers: CNK as a reference in communication CONCLUSION APPENDIX: MSI barcode Specifications 2 INDEX Application for national code number ...................................................... 7 Application for barcode .......................................................................... 15 Barcode ................................................................................................... 15 Technical information ........................................................................ 23 Databases distributed by APB................................................................. 17 CNK (national code number): ................................................................... 5 Definitions ............................................................................................ 5 When is a new code needed ................................................................. 8 Calculating the check digit ................................................................... 5 Coded series ......................................................................................... 6 Barcode ............................................................................................... 15 Form ............................................................................................................ Application for CNK for registered medicines .................................... 9 Application for CNK for unregistered products ................................. 10 Retention of CNK for refundable medicines ...................................... 11 Retention of CNK for refundable products ........................................ 12 Applications ............................................................................................ 17 Barcodes ............................................................................................. 18 in the pharmacy .................................................................................. 19 in the hospital pharmacy..................................................................... 20 for distributors and manufacturers ..................................................... 21 Unique numeric code ............................................................................... 16 Scientific Database .................................................................................. 17 Changes ................................................................................................... 14 Changes relating to products .............................................................. 14 Price changes ...................................................................................... 14 Other changes ..................................................................................... 14 3 INTRODUCTION This brochure is intended mainly for manufacturers, distributors and importers of pharmaceutical and parapharmaceutical products, but is also a useful source of information for pharmaceutical wholesalers, pharmacists and anyone closely involved in the distribution or dispensation of drugs or parapharmaceutical products. This brochure gives a brief and clear overview of the procedure for coding of pharmaceutical and parapharmaceutical products, the procedure to be followed for notifying changes, the use of barcodes and a few other applications. The purpose of the national code number is to identify univocally all forms of packaging of products that are delivered in pharmacies open to the public. Furthermore, all drugs dispensed in care institutions (hospitals, nursing homes, etc.) are encompassed within the coded products. This enables computerised interchange of all the possible data between all the aforementioned groups. The APB (Belgian Pharmaceutical Association) national code number is therefore becoming more and more important due to: the increasing computerization of pharmacies; automated orders by the pharmacist (order protocol); telecommunication between wholesalers and manufacturer, the use of EDI applications. It is useful to bear in mind that the coding is done in close cooperation with the relevant authorities: products eligible for refund by the National Institute for Health and Invalidity Insurance (subsequently referred to by its Dutch and French acronyms RIZIV and INAMI). The collection of statistics regarding any dispensation in hospitals is based on national code numbers. Both the FPS of Economic Affairs and the FPS of Public Health use the APB codes to supplement their own information. Access to the national code numbers is open to all stakeholders: the code numbers are made available to the various stakeholders in the pharmaceutical sector. The general use of the national code is a logical consequence of this, but it requires us to offer a database that is as comprehensive as possible and which resembles as closely as possible the actual market situation for the products listed. You will understand that the maintenance of the data in this database requires meticulousness and particular attention. This can only happen with the kind cooperation of all stakeholders in the pharmaceutical sector. You, as a partner, are one of these parties and we hope that this brochure provides an answer to any questions you may have regarding this code. Pharmacist L. VANSNICK Director of the Tariff Office Pharmacist L. ZWAENEPOEL Chairman of the APB. 4 NATIONAL CODE NUMBER 1. Description The national code number (referred to by its French/Dutch abbreviation CNK) is assigned to all drugs, parapharmaceutical products (medical devices, biocides, food supplements, cosmetics …) dispensed by the pharmacy; both for human, veterinary and phytopharmaceutical purposes. This code is merely a sequential number with no analytical significance. It is assigned to each product based on its: name; galenic form; composition; dosage; packaging. The CNK is an administrative number. The attribution by APB of a CNK does not mean that APB also recognizes that the product complies with all legal aspects for being validly on the market. This aspect remains the entire responsibility of the one bringing it on the market. For the attribution of the CNK, APB entirely depends on the information received from the applicant of the CNK. As soon as one of these items of data changes, a CNK is required. Only for a name change of a product for which a refund by RIZIV/INAMI is allowed can an exception be made. Price, VAT, refund procedures, manufacturer, distributor ... play no role in the assignment of the CNK. However, these items of data are extremely important parameters for the Tariff of Pharmaceutical Specialities, the information base of pharmaceutical and parapharmaceutical products and the Tariff for Hospitals, all published by APB. We ask you please to keep APB informed at all times of any change affecting your products. 5 Since 1 January, 1993, the CNK has consisted of 7 digits; 6 random digits and a 7th check digit, calculated using modulus 10. How is the modulus 10 check digit calculated? Multiply the digits of the CNK alternately by 2 and 1, starting from the right. Add up all the numbers, except those greater than 10, for which the figures must be added up separately. Subtract from the next highest multiple of ten. e.g. CNK = 1013168, where the check digit is 8. 1 x1 = 1 0 x2 = +0 1 x1 = +1 3 x2 = +6 1 6 x1 x2 = = +1 +1+2 8 =12 20-12 =>8 The CNK should be verified whenever it is used by means of the check digit. Failure to use the check digit undermines the reliability of the code and can lead to errors. A checking program must be present on computers, barcode readers and any decoding equipment. 2. Overview of coded series The current structure (6 digits + 1 check digit) allows the possibility of encoding 999,999 products. However, the following series are reserved: from 0000-018 0010-000 0500-000 0600-000 0700-000 0800-000 0900-000 1000-000 4000-000 5000-000 5500-000 7700-000 9910-000 to 0009-999 0499-999 0599-999 0699-999 0799-999 0899-999 0999-999 3999-999 4006-999 5499-999 5599-999 7799-999 9919-999 are reserved for the Tariff Services national code reserved for pricing of magistral preparations national code reserved for RIZIV/INAMI (hospital products) national code reserved for pharmacists for their own use national code reserved for oxygen reserved for pricing of magistral preparations for fees and flat rate charges in pharmacies reserved for RIZIV/INAMI reserved for wholesalers All other, unlisted series are currently not active and should not be used. They will gradually be brought into use in future. 6 APPLICATION FOR NATIONAL CODE NUMBER When encoding products, APB depends entirely on information transmitted by the applicant of the CNK at APB. Specific information about the product is required in order to assign a national code number. The application form for national code numbers gives you an overview of the information necessary. We recommend that you use the attached application forms. Please note, these application forms are different for registered and unregistered products. Any applicant for the assignment of a CNK should be submitted to: Dienst van het Tarief der Farmaceutische Producten (Pharmaceuticals Tariff Service) APB rue Archimedesstraat 11-1000 Brussels Tel. 02/285 42 00 Fax. 02/285 42 75 Addressed to Mrs. Lieve Wuyts, Mrs. Kerlijne Van den Broeck or Mrs. Joke Smedts lieve.wuyts@apb.be kerlijne.vandenbroeck@apb.be joke.smedts@apb.be We wish to draw your attention particularly to the following points: - use one form per requested code; - fill in the form as completely as possible; - always mention a person to contact; - if you wish the CNK to be converted into a barcode (in return for payment), you can request this on the form; - if the data submitted may not be disclosed to third parties before a certain date, this may be indicated in the top right-hand corner. No later than 15 days before the time when the CNK may be released, please contact the service to report this. - hospital packaging: in the case of hospital-specific packaging (bulk, UD) you must indicate this on the form; - please do not hesitate to contact us in case of difficulties completing this form. 7 The application for and assignment of a CNK is completely free of charge. For encoding of lists or ranges of products, please contact our service to carry out the encoding as quickly and efficiently as possible; in this case, an Excel file may also be sent by e-mail. In which cases is no new CNK required? - for a price change; - for a change in the VAT rate; - to amend the refund arrangements; - when changing the distributor or licensee. In each of these cases, however you still need to inform APB promptly so that all users can be notified. In which cases is a new CNK required? - for any change in the name of the product; - for any changes to the galenic form or by any significant change in the presentation of the galenic form; - for any qualitative or quantitative change in the composition of the active ingredients; - for any qualitative change in the composition of the excipients. - for any change in the content (weight, volume or number of units) of a package. Re-use of CNK for parapharmaceutical products for CNK is no longer allowed under any circumstances because of the mandatory display of prices in the pharmacy, imposed by the Federal Government Service for Economy. Exception: for a name change of a product eligible for refund by RIZIV/INAMI, an application may be submitted to retain the CNK, if the only change relates to the name. The form 'Application to retain the CNK due to name change' should be used for this purpose. This exception can only be allowed for medicines, medical devices and medical dietary products, for which an allowance is paid by RIZIV/INAMI. This application will be processed in liaison with the Department of Medical Care of RIZIV/INAMI. Only if this service has all the necessary documents at its disposal, may retention of the CNK be authorised. If in doubt please always check with APB. 8 APPLICATION FOR NATIONAL CODE Registered medicines DEMANDE DE CODE NATIONAL Médicaments enregistrés Send to: APB, Dienst Tarief, Archimedesstraat 11, 1000 Brussels A envoyer à : APB, Service du Tarif, Rue Archimède 11, 1000 Brussels Tel. : 02/285.42.72 - Fax : 02/285.42.75 E-mail: lieve.wuyts@apb.be Voor de veterinaire geneesmiddelen – Pour les médicaments vétérinaires: Tel. : 02/609.46.53 Reserved for APB - Réservé APB Fax : 02/285.42.75 E-mail : joke.smedts@apb.be Keep confidential Yes / No* Until: Tenir confidentiel Oui / Non* Jusque : National Code Number – Code National CNK: Applicant – Demandeur VAT / TVA : Website: Firm / firme : Tel.: Contact / Personne de contact : Fax: Address / Adresse: E-mail: Registration - Enregistrement Registration number / Numéro d'enregistrement [!] : Name - Dénomination a. Name / Dénomination [!] : copy or / ou generic - generique * as stated on the packaging /comme mentionné sur l’emballage b. Name in second language / Dénomination 2ème langue: only if stated on the packaging / uniquement si mentionné sur l'emballage c. Registered name / Dénomination enregistrée [!] : only if different from a. /uniquement si différente de a. d. Registration holder / Titulaire de l'enregistrement : e. Distributor / Distributeur : f. Date of market launch / Année d'introduction sur le marché : Form - Présentation Galenic form / Forme galénique [!] : Number of units or content / Nombre d'unités ou contenu [!] : Dosage / Dosage [!] : Packaging - Conditionnement Packaging / Conditionnement *: Unit Dose / Unidose (AR/KB 14/12/2006 )*: Yes/Oui – No/Non Gebruik - Usage* Humaan/Humain Diergeneeskundig/Vétérinaire Public Price / Prix public : Ex-factory price / Prix ex-usine: Public / public Hospital / Hospitalier IMP/PMI Category – Catégorie* Homeopathie/Homéopathie Kruidengeneesmid./Méd. à base de plantes EURO (VAT / TVA incl.) EURO (excluding. VAT/VAT) VAT / TVA : % Storage - Conservation* - 15° C 2 to/à 8° C 8 to/à 15° C 15 to/à 25° C Barcode (fee payable) to be supplied by APB - Code-barre (payant) à fournir par APB CNK barcode by email / code-barre du CNK par e-mail ? Yes / Oui * e-mail address / adresse e-mail : No / Non * Please enclose a copy of the scientific patient information leaflet in both national languages. Veuillez joindre à la présente demande une copie de la notice scientifique dans les deux langues nationales. Date of application / Date de la demande Name of Applicant / Nom du demandeur . . / . . / . . . . 9 APPLICATION FOR NATIONAL CODE DEMANDE DE CODE NATIONAL Products not registered as medicines Produits non enregistrés comme médicaments APB, Dienst Tarief, Archimedesstraat 11, 1000 Brussels APB, Service du Tarif, Rue Archimède 11, 1000 Bruxelles Tel. : 02/609.46.72 Fax : 02/285.42.75 E-mail : kerlijne.vandenbroeck@apb.be www.apb.be Voor de veterinaire producten– Pour les produits vétérinaires: Tel. : 02/609.46.53 Fax : 02/285.42.75 E-mail : joke.smedts@apb.be www.apb.be Keep confidential * Until: Reserved for APB - Réservé APB Yes / No National Code Number – Code National CNK: Tenir confidentiel Applicant – Demandeur * Jusque : Oui / Non VAT No. / n° TVA: Website: Firm / firme : Tel: Contact / Personne de contact : Fax: Address / Adresse : E-mail: PRODUCT DESCRIPTION / DESCRIPTION DU PRODUIT EAN CODE (13digits) :…………………………… NAME as stated on the packaging ! in NL and FR: DENOMINATION comme mentionnée sur l’emballage! en FR et NL:................................................................. Galenic form; ! : Forme galénique!:......................................... Ref :............................ Promo : YES / NO* Additional form specifications !: Spécifications supplémentaires au niveau de la forme !:................................................ Content / Conditionnement !:............................................................................... Composition / Composition !:............................................................................... New Formula / Nouvelle formule: Yes/Oui – No/Non Application /Application :................................................................ Usage - Usage* : Human Humain Veterinary Vétérinair Category – Catégorie * : Homeopathie Homéopathie Materiaal Matériel Bandagisterie Bandagisterie Voedingssupplement Complément alimentaire Voeding Alimentation Biocide (niet-landbouw) Biocide (non-agricole) Nr. NUT PL AS*: _ _ _ _ / _ _ _ _ *(indicate if necessary/cocher se qui convient) Cosmetica Medisch hulpmiddel voor in-vitro diagnostiek Cosmétique Dispositif médical de diagnostic in vitro Grondstof Medisch hulpmiddel Matière première Dispositif médical Hereby we confirm that the product that is being marketed, complies to all regulations applicable on the category here mentionned. Par la présente, nous confirmons que le produit mis sur le marché respecte la réglementation relative au statut mentionné ci-dessus. Launch date : Date de lancement This product replaces : Date of elimination of old product : Ce produit remplace :....................... Date suppression ancien produit : Laboratory / Manufacturer: Distributor : Laboratoire / Fabricant :..................................Distributeur :................. Country of origin / Pays d'origine : ……………. Recommended public price VAT incl. : VAT % : RECUPEL (amount) Prix Public indicatif Tva incl. :..…..... TVA %:............ RECUPEL (montant) : MSI barcode (fee payable) to be supplied by APB - Code-barre (payant) à fournir par APB CNK barcode by e-mail / code-barre du CNK par e-mail ? Yes / Oui * e-mail address / adresse e-mail : Application date / Date de la demande: ...../...../..... Signature or name/ Signature ou nom: No / Non * Please attach copy of documentation or specimen of packaging. - Joindre documentation ou exemplaire du conditionnement svp. Important note / Remarques importantes Any change to the information marked by the ! symbol or to the composition of the product requires a change in the national code. If in doubt, please always check with APB. 10 Toute modification aux informations marquées par le signe ! ou à la composition du produit entraîne un changement de code national. En cas de doute, n’hésitez pas à contacter l’APB. 11 Application for retention of CNK due to a name change for a speciality eligible for refund Send to: APB, Dienst Tarief, Archimedesstraat 11, 1000 Brussels Tel. : 02/285.42.72 - Fax : 02/285.42.75 E-mail: lieve.wuyts@apb.be Demande de maintien du CNK pour un changement de dénomination pour une spécialité remboursée A envoyer à : APB, Service du Tarif, Rue Archimède 11, 1000 Brussels Reserved for APB - Réservé APB Keep confidential Yes / No* CNK: Tenir confidentiel Oui / Non* Applicant - Demandeur Firm / firme : Tel.: Contact / Personne de contact : Fax: Address / Adresse: E-mail: Current CNK / CNK actuel : Name - Dénomination a. Current name / Dénomination actuelle : b. New name / Nouvelle dénomination : Registration - Enregistrement a. Current registration number / Numéro d'enregistrement actuel : b. Current registration holder / Titulaire d'enregistrement actuel : c. New registration number / Nouveau numéro d'enregistrement : d. New registration holder / Nouveau titulaire de l'enregistrement : Please also inform the Dienst Geneeskundige Verzorging van het RIZIV (Medical Care Service of the National Institute for Health and Invalidity Insurance) (*) about this application and attach a copy of the marketing authorisation. Veuillez également informer le Service des Soins de Santé de l’INAMI (*) de cette demande et joindre à la présente une copie de l’AMM. Date of application / Date de la demande demandeur . . / . . / . . . . * Name of Applicant / Nom du Delete as appropriate / Barrer les mentions inutiles (*) RIZIV Dienst Geneeskundige Verzorging – Pharm. Yoeriska Antonissen – Yoeriska.Antonissen@riziv.fgov.be - Tel : 02/739.71.44 (*) INAMI – Service des Soins de Santé – Phn. Yoeriska Antonissen - Yoeriska.Antonissen@riziv.fgov.be - Tél : 02/739.71.44 12 NOTIFICATION OF CHANGES Any changes must be notified without delay to: APB - Dienst van het Tarief der Farmaceutische Producten (Pharmaceuticals Tariff Service) Addressed to Mrs. Lieve Wuyts, Mrs. Kerlijne Van den Broeck or Mrs. Joke Smedts rue Archimedesstraat 11-1000 Brussels Tel. 02/285 42 00 Fax 02/285 42 75 lieve.wuyts@apb.be kerlijne.vandenbroeck@apb.be joke.smedts@apb.be 1. Changes relating to coded products The following changes may occur: product name storage conditions (temperature, light, ...) VAT rate galenic form; contents of the pack (pack size) qualitative composition of active ingredients and excipients quantitative composition of active ingredients laboratory or distributor market situation (temporary unavailability, deletion of registration, product launch) price product registration returns policy type of packaging (unit dose, strip, ...) 2. Other changes relating to the company or product Changes of address, phone, fax, contact, VAT number, etc. must always be notified. This also applies to any acquisition of an existing product. No later than 15 days before the time when the change is to become effective, please contact the service to report this. 13 For any additional questions, information or notifications you can always contact the Service. If changes are to be made to a product that receives RIZIV funding, RIZIV must also be notified. 14 THE BARCODE The CNK on medicinal drugs is shown on the packaging as follows: The barcode ("symbol" or "drawing") is of the MSI type. This MSI barcode standard is widely supported by all software companies working with pharmacists. The symbol consists of 8 digits, 7 digits of the CNK followed by an additional check digit. The hyphen does not appear in the barcode image. The usual dimensions are: 28mm x 8mm The best colour contrast (and thus the best legibility) is obtained by printing the symbol in black on a white background. More technical information can be found in the Appendix. MSI barcodes The MSI barcodes can be supplied by APB in the form of an "EPS file" by e-mail or on labels. The MSI barcodes are supplied by APB at the price of € 32.60 (excl. 21% VAT - 2016 price) each. For large quantities you can always request a price quote from our service. If, in the future, you wish to change the lay-out of a package with a legacy national code number (6 digit), we strongly recommend applying for a new barcode which will feature the old number preceded by a 0. This should allow for a uniform 7 digit barcode, to simplify the programming in the pharmacy (readers, printing). Where the CNK an indispensable tool for managing stocks of products in pharmacies and in communication with wholesalers (univocal identification of products, data transmission , etc.), using the barcode on the packaging has numerous advantages for the delivery of products. In the public pharmacy, the barcode enables rapid identification of the product, retrieval of information about it in the pharmacy's management system, simplification of stock control and order entry. 15 Hospitals use the barcode for registration of incoming orders for distribution to the various departments and stock control. Moreover, the barcode enables quick and personalized recording of drugs administered to patients; the use of barcodes is indispensable in integrated systems for pharmacovigilance, pricing and billing. Unique numeric code Since the Royal Decree of 5 December, 2003, published in the Belgian Official Journal of 17 December, 2003, the person responsible for marketing must ensure that every package of a refundable speciality carries a unique code number on the outer packaging of public packaging. This unique numeric code must be composed of the following items of information: - CNK, the first 7 characters an ascending sequential number, the next 8 characters a check digit, the last character The code number is displayed in the form of a barcode, type128 subset c, with a density of 0.250 mm. The barcode is 10 mm high and 45 mm wide. Both before and after the barcode there is an empty space of at least 2.5 mm. Below the barcode, the code number is displayed in Arabic numerals, the height of the figures being 2 mm and minimum 1 mm empty space is provided between the barcode and the code in numbers. This information is indelibly printed in black ink on a white, non-glossy and nonremovable adhesive label. 16 APPLICATIONS 1. List of databases published by the Belgian Pharmaceutical Association, and which use the CNK as means of identification of products. A. Prices - Tariff of Pharmaceutical Specialities and Parapharmaceutical Products This database lists all products in pharmacies open to the public as well as the drugs available for hospital use. Besides the name and the CNK the price, the VAT rate, the refund arrangements, the storage conditions and other useful information is included. It is updated twice a month. For information on the deadline for updates, please contact the service. - Tariff for magistral preparations This database enables pricing of magistral preparations (with or without RIZIV funding). It lists all commercially available bulk products with their pricing and refund procedures. - Tariff for Hospitals The Tariff for Hospitals defines the unit dose of all drugs intended for hospitals and their corresponding code (CNK-UD). The databases include all data for pricing and billing for hospitalized and outpatients. Moreover, all the necessary information is contained for the management of pharmaceutical products under "Billing via magnetic media”. The update is carried out monthly. - Tariff for Physicians This database lists all the drugs available to prescribing physicians. B. Scientific databases - Delphi Care The national code number is the key to the scientific database Delphi Care. This gives a complete description of all the Belgian specialities for human use: quantitative (active ingredients) and qualitative composition (excipients), maximum dosage, therapeutic class, contraindications and precautions for use, drug interactions, first issue patient information, copies and generics (prescriptions for substance name), foreign equivalents and a physicochemical monograph of pharmaceutical raw materials. A detailed description of these databases and the contractual conditions can be obtained on request. 17 2. Other applications A. The use of barcodes There are currently various systems available for data entry. Data entry via barcode reading is one of the most efficient; because it combines all the following characteristics: Flexibility In the choice of the optical reader; In the connection with the PC; Easily compatible with printers. Reliability Absence of reading errors Accuracy No more human errors Speed Optical reading is 4 times faster than the manual input User-friendliness The use of these systems requires no additional user training; Compactness of the hardware required. Low running costs 18 B. Use in the pharmacy 1) Input of products delivered to pharmacies The following steps can be distinguished: a) The Unique Digital Register: The pharmacist uses the CNK of the drugs to search the APB database for the regulations that enable him/her to produce the Unique Digital Register in relation with the patient register and with the doctor's name. b) Pricing The pharmacist's computer needs to contain a database of information about specialities which includes data about public prices and refund procedures which is regularly updated. When each drug is dispensed, the barcode is read in, and the pharmacist immediately has access to all the information regarding refunds on the computer screen. c) Pharmanet With Pharmanet, per prescriber, data is collected about refunded pharmaceutical supplies (specialities, magistral preparations, sterile insulin syringes and additional amounts for out-ofhours services …) dispensed via public pharmacies. The collection of data is done through the pharmacies, pricing services of the pharmacists and insurance institutions; the latter pass on their data to RIZIV/INAMI. The main objective of Pharmanet is to inform the prescriber about their prescribing practices and to give him the opportunity to compare this behaviour with that of colleagues. In the context of Pharmanet, it is therefore extremely important that the CNK is used correctly and that all changes to products refunded should be notified as soon as possible to the Tariff Service and RIZIV/INAMI. d) Pharmacovigilance & Patient Safety If the pharmacist has access to the scientific database Delphi Care (interactions, contraindications, maximum dosage ...) the barcode read in enables the pharmacist to be warned of potential risks that the delivery of a medicine may entail. The use of the CNK also contributes to the patient safety: the CNK is used for the recalls organized by the SCM/DGO. CNK and/or UBC are also used for the authentication of medicines in the battle against falsifications. e) Accounting A journal, with breakdown per VAT code or per group of drugs, can easily be established, provided that all products dispensed can be entered quickly and this can be done using barcodes reading. 19 2) Integrated stock control Stock control is a delicate task that requires extreme accuracy in any business. No stock movement should elude the computer: sales, incoming orders, returns of products to suppliers, destruction, sale to staff,... An error in the stock may quickly lead to being unable to dispense drugs or over-stocking. Barcodes facilitate the recording of all these movements in the stock of the pharmacy and allow a number of errors to be avoided. a) Continuous monitoring of the stock Using a portable device, the actual stock can be read in quickly and compared with the theoretical stock according to the pharmacy's computer. This should make it possible to correct any errors and to obtain a reliable stock control system. b) Checking of incoming orders The entry of products into stock on the pharmacist's computer, can easily be done by reading the barcodes on the various packages of an incoming order. In doing this, it is useful to maintain a minimum history of the stock. c) Annual stocktake Barcode reading allows a stocktake to be carried out on a portable device. This device, or the disk containing the results of this recording, handed over to a service company, allows a very accurate calculation of the inventory. The same device connected to the computer allows the pharmacist to calculate the inventory but, more than that, to compare the actual stock of the pharmacy with the theoretical stock according to the pharmacist's computer. C. Use in the hospital pharmacy The individualized dispensation of medicines in hospitals increases the number of treatments with unit doses. The coding of each unit package is an urgent need, as is the automation of the following actions: - writing the prescription; - pharmaceutical analysis of the prescription (in relation with the scientific database Delphi Care); - maintenance of the stock records of the pharmacy; - the input of the consumption by each department; - dispensation to patients ; - communication with other IT applications; 20 - Integration into the overall management of the hospital (keeping the patient's medical record,...). D. For distributors and manufacturers: CNK as a reference in communications The CNK is the identifier of choice for each product and thus enables all partners in the sector to use the CNK as a unique reference and speak the same language. The national code number is an essential tool for all communications applications and EDI. A few examples: - the exchange of data between wholesalers; - passing on price changes from the manufacturer to APB or the wholesaler; - publications or publicity issued by the industry and intended for the pharmacist; - brochures and price lists for the pharmacists; - sales representatives of some companies record the orders in the pharmacy on a portable device using the barcode. The CNK and the corresponding barcode is a commercial eye-catcher and reflects the modern nature of the firm using it correctly. At internal level, the manufacturers also use barcodes as barcode data capture enables quick recording, checking and monitoring of the various steps in the production or distribution process. The barcode allows far-reaching automation and facilitates checking the progress of orders in hand. 21 CONCLUSION To conclude, we would again draw your attention to the need for timely reporting of any detailed information or changes to the products marketed by your company. We thank you for your kind cooperation which enables us to make available a high quality Tariff to pharmacists and ensure excellent cooperation between pharmacists and the pharmaceutical industry. ______________________ This brochure is published by: The Belgian Pharmaceutical Association APB rue Archimedesstraat, 11 1000 Brussels. where it may be obtained free of charge. This brochure has been prepared on the basis of information available (recently revised on 5 January 2015). If the reader should notice errors or inaccuracies, we kindly ask that they be reported to us. The publisher cannot be held responsible for any errors that occur in this publication, nor for any mistakes, incorrect use or any damage resulting from the information or lack thereof in this edition. 22 Appendix: MSI Barcode Specifications Introduction The following information is intended to provide information to persons responsible for printing barcode symbols that will be scanned by MSI scanners. This information is subject to change without notice. A high degree of printing quality is required for barcode symbols. An MSI representative can help you contact printers who have demonstrated the required expertise in the past. Description The symbol consists of the following elements: a forward start code, four bars with intervening spaces for each encoded digit, one or two symbol check digit(s) and a reverse start code. The MSI scanner contains a light source that illuminates the symbol. The light is either absorbed by the dark bars or reflected by the spaces between the bars. The scanner reads the encoded digits by comparing the width of each dark bar to the space following it, as the scanner is moved across the symbol. If the bar is wider than the space, it is considered to be a "one bit". A bar that is narrower than the space following it, is a "zero bit" in the forward direction. Data Code Each digit consists of four bits in binary coded decimal (BCD) form. In the following table an "0" is the equivalent of a narrow bar/wide space and a "I" is equal to a wide bar/narrow space. Decimal 0 1 2 3 4 5 6 7 8 9 BCD 0000 0001 0010 0011 0100 0101 0110 0111 1000 1001 23 Symbol elements Start code, forward : The forward start code is a single 'one' bit (wide bar/narrow space). Data Field :The user may have up to 14 digits in the data field if the check digit is included. If the user does not provide a check digit, a maximum of 13 digits can be used in the data field. Check Digit : The modulus 10 MSI check digit which is transparent to the user is one or two digits, depending on the user's data field format. Start Code, Reverse : The reverse start code is a single 'zero' bit followed by a narrow bar (narrow bar/wide space/narrow bar). 1-14 DIGIT (or 1-13 DIGIT) USER DATA FIELD 1 DIGIT (2 DIGIT) MSI MODULUS 10 CHECK DIGIT FORWARD START CODE REVERSE START CODE Symbol Elements A. Bar Edge Bar edge is defined as the half-amplitude point between maximum reflection from the background and minimum reflection from the bar. For instrumented measurements a .008 inch diameter aperture shall be used. 24 B. Bar Width The actual bar/space width depends on the print tolerances that can be maintained in production. The bar and space edges must fall within the specified tolerances over at least 80% of the bar heights, exclusive of the top and bottom 5%. Narrow Bar Wide Bar or Space or Space _________ _________ .008 .017 .012 .025 .016 .032 .020 .040 .024 .048 All dimensions are in inches. Tolerance ________ +/- .0015 +/- .003 +/- .004 +/- .006 +/- .008 C. Bar Height Minimum bar height is 0.3 inch. In practice, the user would be advised to make the bars as high as possible for acceptable first pass read rates. This is most significant in shelf labels. D. Edge Roughness Edge roughness is included in the bar width specification (A above). E. Margins A blank reflective area of at least 0.25 inch shall be at the left and right of the barcode. F. Digit Spacing The digits are not dimensionally independent. The spaces between digits must fall within the tolerances listed in A. above. 25 Print Quality Factors A. Background Diffuse Reflectance There are no requirements on background diffuse reflectance provided the contrast requirements ( D below) are met. B. Background Uniformity There shall be no detectable patterns in the background within the barcode area or margins. C. Ink Film Reflectance The ink film reflectance shall be 25% maximum measured with a Macbeth model PCMII print contrast meter or equivalent with a standard response "D" filter. The aperture is .008 inch diameter and the filter is a 30nm Interference filter peaked at 905nm with 3050K source and a silicon detector. The reflectance shall be the maximum reading obtained over the total bar height exclusive of the top and bottom 5%. D. Print Contrast Signal Minimum print contrast signal (PCS) between bars, and spaces between bars, is 50% over the barcoded height exclusive of the top and bottom 5%. It is measured under the same conditions as ink film reflectance (C) and defined as : PCS = Rw - Rb Rw Rw = % reflectance of spaces Rb = % reflectance of bars E. Voids Voids (poorly inked areas within bars) are not separately specified but included within ink film reflectance requirements(C). F. Ink and Dirt Spots These are not separately specified but included in the contrast requirements (D). 26 G. Smear and Scratch Resistance The ink must not smear during the life of the label. The wand may have a plastic tip that reduces the scratching effect on the label surfaces. If the symbol life will be short and the symbol will be in a protected environment, a protective coating over the symbol may not be required. It is recommended that adequate testing with various inks and paper stock be done prior to committing to such an application. For applications such as supermarket shelf labels where months of use and many scans are expected, a transparent protective coating is virtually mandatory. H. Testing Before the printer begins production runs for the first time, he/she should have samples tested. The purpose of the test will be to ensure that : a) the symbol dimensions and printing are within tolerances; b) the ink and background reflectivity will provide reliable scanning; c) the protective coating does not degrade the printing quality or reflectivity to an unacceptable degree. The initial approval of the samples must not be construed to mean that there is a high quality of subsequent symbols produced by that printer. It is simply a method whereby the printer may determine at the outset whether the methods and materials he intends to employ are suitable for the purpose. For quality assurance of his production runs, the printer should acquire or have easy access to an MSI Data Corporation data entry terminal equipped with a scanner unit. 27