Classifications

• • G—PHYSICS
  • G07—CHECKING-DEVICES
  • G07C—TIME OR ATTENDANCE REGISTERS; REGISTERING OR INDICATING THE WORKING OF MACHINES; GENERATING RANDOM NUMBERS; VOTING OR LOTTERY APPARATUS; ARRANGEMENTS, SYSTEMS OR APPARATUS FOR CHECKING NOT PROVIDED FOR ELSEWHERE
  • G07C1/00—Registering, indicating or recording the time of events or elapsed time, e.g. time-recorders for work people
• • G—PHYSICS
  • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
  • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
  • G16H20/00—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance
  • G16H20/10—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients
• • G—PHYSICS
  • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
  • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
  • G16H10/00—ICT specially adapted for the handling or processing of patient-related medical or healthcare data
  • G16H10/40—ICT specially adapted for the handling or processing of patient-related medical or healthcare data for data related to laboratory analysis, e.g. patient specimen analysis

Definitions

• Counterfeiting is a longstanding problem. Counterfeit medicines, in particular, which are of poor quality in terms of purity and / or composition compared to the original products, endanger the safety of patients. According to the World Health Organization (WHO), 771 cases of counterfeit medicines were reported by April 1999, with 40% of 325 cases analyzed and the nature or quality of the active components contained, and 59% containing no active components. For example, the placing on the market and later taking paracetamol syrup, which was associated with the
• the WHO recommends an organoleptic examination of the packaging and content of the product, followed by either simple analytical methods such as thin-layer chromatography or a complete analysis by the responsible regulatory authorities (WHO publication ⁇ WHO / EDM / QSM / 99.1, pages 1 - 5 and 33 - 37).
• Medicines are also labeled for traceability during the distribution route from the manufacturer to the retailer and on to the consumer or patient, for example in order to provide specific access to certain batches of the product in the event of product recalls.
• the labeling is. applied to the product in the form of plain text and, in the case of medication or cosmetics, contains a batch number, the expiry date and a unique article name, for example the pharmaceutical central number (PZN) for medicinal products. If necessary, the sales unit is also with the date of manufacture and an individual serial number.
• PZN pharmaceutical central number
• the sales unit is also with the date of manufacture and an individual serial number.
• all or part of this information is also machine-readable in the form of a one or two-dimensional code.
• German laid-open specification DE 100 19 72 A1 describes a method for product security, the product being provided with a first encrypted identification and the associated packaging with a second encrypted identification, the second identification being dependent on the encrypted content of the first identification and thus conclusions on the relationship between packaging and product.
• European patent EP 360 225 B1 describes a device for applying value stamps to postal items, the value stamp containing an encrypted message in the form of a two-dimensional code, and the code being encrypted by means of a public key using an asymmetrical encryption method, which enables the validity of the postage payment to be checked ,
• the object of the present invention is to provide a method with which the authenticity of products, in particular medicaments, can be checked in a simple and inexpensive manner.
• the present invention accordingly relates to a method for identifying a product, wherein 1. the product is labeled with at least one originality component consisting of at least one individual identifier in unencrypted form (A) and at least one individual identifier in encrypted form (B),
• the unencrypted identifier (A) contains at least one individual identification number and optionally one or more further features,
• the encrypted identifier (B) is generated from the content of the unencrypted identifier (A), and
• the originality component is in plain text or in machine-readable form.
• the originality component can be converted into a machine-readable code for practical handling and automatic control.
• the originality of the product can be deduced by decrypting the encrypted identifier.
• Product in the sense of the present invention means a commercial product in any form, for example a pharmaceutical product or a cosmetic, preferably blood preserves, blisters, ampoules, vials, syringes, tablets, capsules, capsules, lozenges, plasters, tubes, inhalers, squirt bottles, and / or packaging or outer packaging or packaging combination thereof.
• the tamper-evident feature can contain 1 to 1000 characters, preferably the non-encrypted individual identifier (A) contains 5 to 30 characters and the encrypted individual identifier (B) 30 to 300 characters.
• Article number preferably a PZN, an EAN (European Article Number), UPC (Universal Product Code), NDC (National Drug Code) or NHRIC (National Health Related Item Code), and / or
• the individual identification number is formed from the article number, preferably the PZN, the batch name and a consecutive number within the batch.
• the originality components can be machine-readable or in plain text.
• the originality components can consist of any characters, preferably of letters, numbers, special characters and / or patterns, particularly preferably the originality components are numerical or alphanumeric.
• the originality components are preferably displayed in a machine-readable manner, particularly preferably as a two-dimensional code.
• the originality components can also be attached to the product in a magnetic strip or stored in a chip.
• a code can be black and white, black on white or white on black, or colored or multicolored.
• a code can be affixed to the product by printing or labeling the product using any type of printer, for example an ink jet printer, laser printer, laser marker, matrix printer, dot matrix printer or
• a machine-readable code can be read with a commercially available scanner, for example with a laser scanner or a CCD camera, for example the Imageteam® 440 device from WelchAllyn®, Domstetten, Germany.
• a one-dimensional code is, for example, Code 39, Extended Code 39 or Code 128.
• Two-dimensional codes are, for example, 3D barcode, 3-DI, ArrayTag, Aztec Code, Small Aztec Code, Codablock, Code 1, Code 16K, Code 49, CP Code, Data Glyphs, Data Matrix Code, Datastrip Code, Dot Code A, hueCode, MaxiCode, MiniCode, PDF417, Micro PDF417, QR Code, SmartCode, Snowflake Code, SuperCode, Ultracode (company brochure from Barcodat “2D code primer, systematization and reading devices ", Barcodat GmbH, Domstetten, Germany, March 1998).
• Preferred is the Data Matrix Code (Code ECC 200, International Symbology Specification - Data Matrix; ANSI / AIM BC11-1997, May 8, 1997, published by AIM International Inc., Reston, USA).
• the Data Matrix Code is a two-dimensional machine-readable symbol code that can be used to store 1 to 3116 numeric or 2335 alphanumeric characters or 1556 bytes of binary information.
• the Data Matrix Code consists of 4 essential components: a fixed boundary, a broken boundary, a data storage area and a "QuietZone".
• the fixed limit allows the decoder to calculate the orientation of the data matrix code.
• the broken boundary allows the decoder to determine the number of columns and rows or the matrix density.
• the data storage area contains the binary information that was encoded during the creation of the data matrix code.
• the "quiet zone” is an unprinted zone which surrounds the data matrix and whose color differs from that of the fixed border. If the fixed border has a dark color, for example black, the "quiet zone” is light, preferably white.
• Each encoded character within the data matrix is represented by an 8-bit binary code.
• the character “M” is, for example, "01001101", in which "1” is preferably a dark zone within the data matrix, and "0" is a light zone.
• the data matrix code has the advantage over the barcode that it offers a higher storage space and increased readability due to the error correction procedure (ECC), which means that less demands are made on the printer and the space requirements.
• ECC error correction procedure
• An asymmetrical method is used for encryption, in which the individual identifier (A) is encrypted with the secret part (e) of the key. Data encrypted with the secret part of the key can only be decrypted with the public part (d) of the key. It can therefore be concluded that encrypted data that can be decrypted with the public part of the key (d) was encrypted with the secret part of the key (e). Since the secret part of the key is not accessible to the public, the author or producer of the data and thus of the product can be proven beyond any doubt.
• Asymmetric encryption methods are, for example, the method according to Rivest, Shamir and Adleman (RSA method), McEliece, EIGamal, LUC or Diffie Hellman.
• the RSA method for generating the keys and encryption is preferred, as described, for example, in US Pat. No. 4,405,829.
• this method also defines the publicly accessible module (s), which is necessary for the encryption and decryption of the data.
• the level of encryption is based on the length of the key used.
• a key with a length greater than or equal to 1024 bits is preferably used, corresponding to an RSA module of at least 309 decimal digits.
• the public part of the key (d) and the module (s) are made available to the buyer and / or dealer of the product identified according to the invention,
• this part of the key can be stored on a publicly accessible data server or on the Internet, or can be attached to the product.
• the method enables the buyer and / or dealer to determine the manufacturer of the product without a doubt as long as the secret part of the key (s) is not published.
• the originality components are read and the encrypted individual identifier (B) is decrypted with the public part of the key. If the identifier obtained after decrypting the encrypted part (B) corresponds to the identifier in unencrypted form (A), this means that firstly the encrypted part (B) was generated with the secret part of the key, and therefore secondly the source or the manufacturer of the product has generated the encrypted part (B), and therefore thirdly the source or the manufacturer of the product has been identified as the owner of the secret part of the key.
• Counterfeit products can be detected with the method according to the invention: corresponds to the individual identifier which is obtained after decrypting the encrypted identifier (B) using the mean public key (d) and the module (s), the individual identifier which is contained in the unencrypted identifier (A ) is included, the individual identifier was generated by the owner of the secret key (s).
• the individual identifier is used only once. Identical copies of the product can therefore be identified by comparing the individual identification number with previously used individual identification numbers that have been registered by the wholesaler, dealer or customer or published by the manufacturer. Series copies can be easily identified at wholesale through series recognition.
• the product and / or the packaging or outer packaging is labeled with at least one originality component consisting of at least one individual identifier in unencrypted form (A) and at least one individual identifier in encrypted form (B), 2. the unencrypted form (A) of Product identifier additionally included as part of the message to be encrypted in the outer packaging, which carries its own identifier (identifier of the outer packaging), and where
• the originality of the outer packaging and the individual products contained therein are characterized in that the decoded message must also contain the originality component of the product in addition to the identifier of the outer packaging, and
• the identifier of the outer packaging is generated independently of the product identifier.
• the difficulty with counterfeiting is that the product identifier has to be falsified as well. Otherwise, a serial counterfeit can already be seen in a single pack.
• the method according to the invention is suitable as protection against forgery of the expiry date.
• Many consumables such as pharmaceuticals, cosmetics or food, have an expiration or expiry date.
• third parties manipulate the shelf life / expiry date with fraudulent intent.
• the method includes the following elements and process steps: 1.
• the expiry or expiry date is part of the unencrypted form (A) of the product identifier and is encrypted with a private key of an asynchronous encryption method;
• the result of the encryption (encrypted message) and the unencrypted expiry or expiry date is applied to the sales package.
• the encrypted message is preferably applied in a machine-readable manner using a one- or two-dimensional code such as the DataMatrix code or by means of other electronically readable methods such as magnetic strips, memory chips, transponders or by means of biocoded methods;
• the consumer or the dealer has the option of checking the originality of the expiry or expiry date, the decoder decoding the encrypted message with the associated public key and receiving the original expiry date or expiry date in the decoded message, provided that this is not encrypted with it applied durability-or
• the private key can only be determined by third parties using extremely time-consuming computing methods. With correspondingly long keys, the computing time is longer than the shelf life / expiry time. In this way, manipulation by third parties can be ruled out, provided the private key is kept safe and the encrypted message is always part of the product.
• Examples 1 to 7 demonstrate the principle according to the invention with a reduced amount of data, the message to be encrypted being a letter.
• Examples 8 and 9 show an embodiment of the method according to the invention, the message to be encrypted being approximately 47 ASCII characters and the key length being a few hundred bits.
• Example 1 Principle of generating the private and public key using
• the Euler PHI function applies, which specifies the number of all integers to n integral numbers that are smaller than n:
• d is relatively prime to PHI (n).
• e and d are the keys, n the so-called module or modulo.
• the program runs on 80x86 PCs with Microsoft 32bit Windows (NT / 2000 / XP / 95B / 98 / ME). It was written in Microsoft Visual Basic 6.0.
• ClientHeight . 10620
• ClientLeft 45
• ClientTop 330
• txt concatenated text txt untranslated ascii.Text + "/" + txt mixed text
• the message to be encrypted is the letter "A", which, as a decimal number according to the ASCII code, is the number 65 or corresponds binary to the number sequence 0100 0001.
• the message is encrypted with the private part of the key.
• the encrypted message is 241 in decimal notation and 1111 0001 as a binary number.
• Example 4
• Example 3 The encrypted message generated in Example 3 in unencrypted and encrypted and in each case in binary form became a data matrix in accordance with the rules in "AIM International Symbology Specification Data Matrix, Annexe M" using the cloud printing system m600 (controller item no .: 620100) Code generated and displayed: unencrypted encrypted decimal: 65 241 binary: 0100 0001 1111 0001
• the data matrix code shown was created using a data matrix code printer, e.g. Cloud m600 printing system / printhead art. 620300, printed on medication packaging.
• a data matrix code printer e.g. Cloud m600 printing system / printhead art. 620300, printed on medication packaging.
• the unencrypted message was also printed on the packaging in decimal and binary notation.
• Read the information contained in the data matrix code can be obtained from stationary retailers .
• Code readers for example commercially available products from Pharma Controll Electronic GmbH, type: camera data matrix control system, can be read out.
• a check for serial counterfeiting is carried out by comparison with already known identification numbers.
• the information contained in the data matrix code is read out, for example, using hand-held readers such as Welch Allyn Inc., type: 0 4410HD-131 CK.
• the public key and the module are offered on the Internet by the manufacturer of the product (e.g. the drug).
• the decrypted message therefore corresponds to decimal 65 or binary 0100 0001.
• the decrypted information is compared with the unencrypted information to determine the originality. .0
• Example 2 The program described in Example 2 was used for decryption and verification.
• the unencrypted elements of the message and the encrypted message are shown in two separate data matrix code symbols.
• the example was carried out analogously to Examples 1 to 6.
• the private and public key were generated with the module size of 1024 bit according to the example.
• the message to be encrypted was an individual identification number consisting of LOT number. (40A020), EXP (10.2003), PZN (-0587985) and individual identification (00000001).
• Data Matrix Code ECC200 encrypted with the private key in Data Matrix Code ECC200, whereby the unencrypted message was mapped in Data Matrix Code - Symbol 1 (corresponding to a symbol size of 24x24 Data Matrix modules) and the encrypted message was mapped in Data Matrix Code - Symbol 2 (correspondingly a symbol size of 52 x 52 data matrix modules)
• a blister containing a drug was identified.
• Identification number consisted of PZN, LOT (batch number) and an individual serial number.
• the encryption method was the RSA method.
• FIGS 1 to 3 show the method according to the invention according to Example 8.

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• Engineering & Computer Science (AREA)
• Health & Medical Sciences (AREA)
• Primary Health Care (AREA)
• Public Health (AREA)
• Medicinal Chemistry (AREA)
• Epidemiology (AREA)
• General Health & Medical Sciences (AREA)
• Medical Informatics (AREA)
• Chemical & Material Sciences (AREA)
• Bioinformatics & Cheminformatics (AREA)
• Physics & Mathematics (AREA)
• General Physics & Mathematics (AREA)
• Medical Treatment And Welfare Office Work (AREA)
• Medicinal Preparation (AREA)
• Storage Device Security (AREA)
• Details Of Rigid Or Semi-Rigid Containers (AREA)
• Medical Preparation Storing Or Oral Administration Devices (AREA)

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• 2002
  • 2002-05-17 DE DE10222569A patent/DE10222569A1/de not_active Withdrawn
• 2003
  • 2003-05-02 MX MXPA04011359A patent/MXPA04011359A/es unknown
  • 2003-05-02 AU AU2003227703A patent/AU2003227703A1/en not_active Abandoned
  • 2003-05-02 WO PCT/EP2003/004591 patent/WO2003098543A1/de not_active Application Discontinuation
  • 2003-05-02 JP JP2004505968A patent/JP2005525895A/ja not_active Abandoned
  • 2003-05-02 IL IL16521503A patent/IL165215A0/xx unknown
  • 2003-05-02 EP EP03725130A patent/EP1508121A1/de not_active Withdrawn
  • 2003-05-02 CA CA002486683A patent/CA2486683A1/en not_active Abandoned

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