National Code Number 5 Barcode


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
[email protected]
[email protected]

[email protected]
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: [email protected]
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 : [email protected]
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 : [email protected] www.apb.be
Voor de veterinaire producten– Pour les produits vétérinaires:
Tel. : 02/609.46.53
Fax : 02/285.42.75
E-mail : [email protected]
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: [email protected]
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 – [email protected] - Tel :
02/739.71.44
(*) INAMI – Service des Soins de Santé – Phn. Yoeriska Antonissen - [email protected] - 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
[email protected]
[email protected]
[email protected]
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.
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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;
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- 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.
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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
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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.
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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.
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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).
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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.
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