Product Identification And Labelling For Pharmaceutical .

2y ago
34 Views
4 Downloads
742.00 KB
22 Pages
Last View : 1m ago
Last Download : 2m ago
Upload by : Brady Himes
Transcription

Product Identification and Labelling for PharmaceuticalProduct Guidance and TemplateVersion 1: September 2020

How to Use the DocumentThe Product Identification and Labelling for Pharmaceutical Products Guidance and Template documentincludes two sections: guidance and template. The guidance section provides key considerations that acountry should use as decision points to aid in applying the template to the country context.The template section is not intended to be prescriptive, but rather to serve as a guide for draftingidentification and labeling requirements for pharmaceutical products. It is designed to provide tradingpartners with further information on how to implement existing regulations on labelling pharmaceuticalproducts and medicines to be distributed on the country market. This section includes numerousprovisions that must be tailored specifically to the country context. These provisions are noted in [bluebrackets].ghsupplychain.org @ghsupplychain2

BackgroundThe Product Identification and Labelling for Pharmaceutical Products Guidance and Template document isintended for use by national drug regulatory authorities (NDRAs) alongside the Guidance Model Directivefor Traceability Regulation Development (model directive) in developing pharmaceutical labelling andpackaging requirements to advance supply chain security. The model directive helps countries thinkthrough in-country regulation and includes guidance in how to identify gaps and recognize areas ofenhancement in line with the traceability implementation process. This document is intended to specifyhow to implement that regulation in accordance with good global practices that leverage GS1 standards.Product identification and labelling requirements should reference existing regulations and statutoryinstruments such as ministerial orders on medicines control and packaging/labelling of the medicines inthe country. Where such instruments do not exist, the NDRA should decide on the applicable countryframework to regulate guidelines specified in this document.ghsupplychain.org @ghsupplychain3

Key ConsiderationsFocus AreaKey ConsiderationIntroductiona. In this section, the NDRA should outline the goals that have beenidentified in the country’s National Traceability Strategy that will beachieved through implementing global standards and traceability.Description ofa. Readers of the document should consult the GS1 GeneralPackagingSpecifications and the GS1 AIDC Healthcare Implementation Guideline,Levelsor their GS1 Member Organization for more information.Producta. NDRAs should refer to existing regulation on whether or notIdentification1) serialization is in scope for traceability implementation andand Labelling2) guidance on the type of barcode on packaging types shouldRequirementbe updated to align with the regulation.forb. In-scope and exempt commodities should align with those describedPharmaceuticalsin the statuary instrument.c. Dates for compliance with labelling and packaging requirementsmust align with those mandated in the statutory instrument.d. The NDRA may mandate the order in which data are encoded intothe data carrier. Where there is no such mandate, it isrecommended that fixed-length data elements precede variablelength elements.Overview ofa. This document is based on the use of the GS1 General SpecificationsRelevant Globalas the primary reference document for technical specifications toStandardsimplement in accordance with GS1 global standards. GS1 GeneralSpecifications should be considered as a reference, as specificationsare subject to regular updates.ghsupplychain.org @ghsupplychainReferenceSection 1Sections 5and 7Section 6.1Section 6Sections 6.1,6.2, and 6.3Sections 6.1,6.2, and 6.3Section 74

Product Identification and LabellingRequirementsGovernment of [Country]Reference Regulation: No. . of . / . /2020Governing the Implementation of Global Standards and Traceability forPharmaceutical ProductsFor Comments: [INSERT CONTACT INFORMATION]For the latest updates, please visit the [REGULATORY AUTHORITY] website: [INSERTWEBSITE]1

Revision HistoryVersionAuthorDateComments2

Contents1. Introduction . 42. Rationale . 43. Purpose . 44. Scope . 45. Description of Packaging Levels . 45.1 Tertiary packaging . 55.1.1 Logistic unit . 55.1.2 Trade item . 55.2 Secondary packaging . 65.3 Primary packaging. 66. Product Identification and Labelling Requirements for Pharmaceuticals . 76.1 Tertiary pack trade item. 76.2 Tertiary pack logistic unit . 86.3 Secondary pack trade item . 97. Overview of Relevant Global Standards . 107.1 Identify . 10AI (00) Serial Shipping Container Code (SSCC) . 10AI (01) Global Trade Item Number (GTIN ) . 10AI (10) batch/lot. 11AI (17) expiration date . 11AI (21) serial number . 127.2 Capture . 12GS1-128 barcode. 12GS1 DataMatrix . 138. Supporting Resources . 15Annex A. Glossary of Terms . 163

1. IntroductionThe Identification and Labelling Requirements for Pharmaceutical Products document outlinesimplementation requirements for those stakeholders in scope for meeting the identification andlabelling provisions outlined in the [NAME OF STATUATORY INSTRUMENT].[NAME OF COUNTRY STATUTORY INSTRUMENT] is established under the [ACT] whosemain mandate: [for example; is to ensure that all medicines and allied substances beingmade available to the country citizens consistently meet the set standards of quality, safetyand efficacy]. With this mandate comes a need to provide guidelines for leveraging globalstandards to provide simplicity and consistency for product identification and labelling. Theseguidelines will enable identification, automated data capture, and exchange of data aboutthese items in ways that can be used in any industry, in any country, and with any tradingpartner.2. RationaleBy leveraging existing global standards for labelling and packaging of pharmaceuticalproducts [COUNTRY REGULATORY AUTHORITY] hopes to create efficiencies in the publicand private health supply chains through standardized identification, automated data capture,and decreased cost in gaining compliance.3. PurposeThis document is intended to provide trading partners with further information on how toimplement [COUNTRY REGULATORY AUTHORITY] Regulations on labelling pharmaceuticalproducts and medicines to be distributed on the [COUNTRY] market. The information in thisdocument is informed by existing good practices and GS1 global standards for labelling andpackaging.4. ScopeThis document applies to all products that fall within the definition of pharmaceutical products[NAME OF COUNTRY STATUTORY INSTRUMENT].5. Description of Packaging Levels 15.1 Tertiary packagingTertiary packaging refers to upper levels of the packaging hierarchy. A tertiary pack may be: A pallet that contains (one or usually) several cases 2A case that contains (one or usually) several items in the items’ primary orsecondary packaging 31Annex A is referenced directly from the Global Standards Technical Implementation Guideline for Global Health Commodities.Available at: es-v212For more information, see GS1 AIDC Healthcare Implementation Guideline, Section 3.5.4, Case/Shipper and Pallet.3ibid.4

Tertiary packaging may be used as either a logistics unit or a trade item. Tertiary packages canbe homogenous (i.e., consisting entirely of the same trade item, batch/lot, and expiry), partial(i.e., consisting of a homogenous pack of items that is not to be considered a trade itembecause it is less than full), or mixed (i.e., either more than one unique trade item or entirely thesame trade item with different batch numbers or expiration dates).It is recommended that labels containing the barcode symbols, with associated HumanReadable Interpretation (HRI), be positioned on two faces of the tertiary packaging to enableready access for scanning when the item is stored, stocked on shelves, or handled.5.1.1 Logistic unitA logistic unit is an item of any composition established for transport and/or storage that needsto be managed through the supply chain. Often, the tertiary package logistic unit is a pallet butmay also be an export carton.The logistic unit is identified using the serial shipping container code (SSCC). This packaginglevel is marked with a GS1 DataMatrix or a GS1-128 linear barcode, either on the packagingitself or on a label affixed to the packaging.5.1.2 Trade itemTrade items are products and services for which there is a need to retrieve predefinedinformation and that may be priced, ordered, or invoiced at any point in the supply chain. Thetertiary package trade item will typically be a case or carton but may also be a shrink-wrappedtray or other configuration.A homogenous pack trade item is identified with a GTIN, batch/lot number, expiration date, andserial number. A mixed or partial pack trade item is identified with an SSCC. When a trade itemis a logistic unit, it is not identified with a SSCC. This packaging level can be marked with aGS1-128 linear barcode or a GS1 DataMatrix, with a strong preference for a GS1 DataMatrix,either on the packaging itself or on a label affixed to the packaging.Examples of tertiary packaging include, but are not limited to:5

5.2 Secondary packagingSecondary packaging is a level of packaging that may contain one or more primary packages, or agroup of primary packages containing a single item. 4 The secondary pack is always a trade item.This packaging level is marked with a GS1 DataMatrix, either on the packaging itself or on a labelaffixed to the packaging.Examples of secondary packaging include, but are not limited to:In-scope commodities can have more than one level of secondary packaging, such as an innerpack (bundles) and intermediate packs (inner case). Identification and marking of inner andintermediate secondary packaging levels are required.Examples of inner or intermediary secondary packaging include, but are not limited to:5.3 Primary packagingPrimary packaging is the first level of packaging that is in direct contact with the item. 5 Thispackaging level is marked with a GS1 DataMatrix, either on the packaging itself or on a labelaffixed to the packaging.Identification and labeling of trade items at this level is optional unless the supplier is providingitems in “cartonless packaging,” i.e., without a secondary packaging level. Marking trade itemsat this level is also recommended where the secondary package will likely be opened orremoved before being dispensed to one or several patients (e.g., a display carton is opened,and individual or split blister packs are distributed to patients).Examples of primary packaging include, but are not limited to:6

6. Product Identification and Labelling Requirements forPharmaceuticalsPer [STATUTORY INSTRUMENT], the following pharmaceutical products are in scope forlabelling and packaging requirements detailed in this section:a. [in scope products]b. [in scope products]c. [in scope products] .Per [STATUTORY INSTRUMENT] the following pharmaceutical products are exempt from theidentification and labelling requirements detailed in this section: An example of this is as follows:a. [exempted products]b. [exempted products]c. [exempted products]6.1 Tertiary pack trade itemAll tertiary pack trade item packages must include a GS1-128 Linear Barcode or a GS1 2DDataMatrix barcode encoded with the following information and printed adjacent to the datacarrier in Human Readable Interpretation (HRI):AI01101721DescriptionGTINBatch/LotExpiration DateSerial NumberRequired byNo later than [DDMonthYY]No later than [DDMonthYY]No later than [DDMonthYY]No later than [DDMonthYY]An example of this in practice:45For more information, see GS1 AIDC Healthcare Implementation Guideline, Section 3.5.3, Secondary Package.For more information, see GS1 AIDC Healthcare Implementation Guideline, Section 3.5.2, Primary Package.7

Encoded in the data carrier, these examples will take on the following teAIBatch/LotNumberFNCSeparatorAISerial Number01108576740020171725123110NYFUL01 GS 2121192A837H7Read through AIDC technology, this example will take on the following format:]d201108576740020171725123110NYFUL01 GS 21192A837H7It is recommended to have fixed-length data elements precede variable-length elements. Whena tertiary pack trade item is also considered a logistic unit, the SSCC can be applied in lieu ofthe serial number.6.2 Tertiary pack logistic unitAll tertiary pack logistic units must include a GS1-128 Linear Barcode 6 encoded with thefollowing information and printed adjacent to the data carrier in HRI:AIDescriptionRequired by00SSCCNo later than [DDMonthYY]An example of this in practice:Encoded in the data carrier, this example will take on the following format:FNC OpeningCharacterAISSCCFNC100006141411234567890Read through AIDC technology, this example will take on the following format:]c1000061414112345678906Per the GS1 General Specifications (Release 19.1), trading partners have the option to include a GS1 2D DataMatrix in addition tothe GS1-128 Linear Barcode on the logistic unit.8

6.3 Secondary pack trade itemAll secondary trade item packaging must include a GS1 2D DataMatrix barcode encoded withthe following information and printed adjacent to the data carrier in HRI:AIDescriptionRequired by01GTINNo later than [DDMonthYY]17Expiration DateNo later than [DDMonthYY]10Batch/LotNo later than [DDMonthYY]21Serial NumberNo later than [DDMonthYY]An example of this in practice:Encoded in the data carrier, this example will take on the following format:FNC umberFNCSeparatorAISerial NumberFNC101108576740020171725123110NYFUL01 GS 2121192A837H7Read through AIDC technology, this example will take on the following format:]d201108576740020171725123110NYFUL01 GS 21192A837H7It is recommended to have fixed-length data elements precede variable-length elements.9

7. Overview of Relevant Global Standards 77.1. IdentifyThe GS1 Application Identifiers (AIs) referenced in this section are used for identifying itemsand locations.AI (00) Serial Shipping Container Code (SSCC) 8The GS1 AI (00) indicates that the data field contains an SSCC. The SSCC is used to uniquelyidentify a logistic unit. The SSCC must remain unique and not be reallocated for a minimum ofone year from the shipment date of the logistic unit from the SSCC assignor to the tradingpartner, in accordance with GS1 General Specifications.The SSCC format is as follows:For more information on how to generate an SSCC and apply it to a logistics label, please referto the GS1 General Specifications and the following resources: ttps://www.GS1.org/docs/tl/GS1 Logistic Label Guideline.pdfAI (01) Global Trade Item Number (GTIN ) 9The GS1 AI (01) indicates that the data field contains a GTIN. The GTIN is the globally uniqueGS1 identification number used to identify trade items (i.e., items that may be priced, ordered,or invoiced). GTINs are assigned by the brand owner of the item and are used to identify itemsas they move through the global supply chain to the hospital or ultimate end user.7Annex C is referenced directly from the Global Standards Technical Implementation Guideline for Global Health Commodities.Available: es-v218For more information, see GS1 General Specifications, Section 3.3.1, Identification of a logistic unit (SSCC): AI (00).9For more information, see GS1 General Specifications, Section 3.3.2, Identification of a trade item (GTIN): AI (01).10

The GTIN can be 8, 12, 13, or 14 digits in length. The format of the GTIN-14 is as follows:For more information on how to generate and maintain a GTIN, please refer to the GS1 GeneralSpecifications and the following resources: ules/en/healthcareAI (10) batch/lot 10The GS1 AI (10) indicates that the data field contains a batch or lot number. The batch/lotnumber field is alphanumeric.The format of the batch/lot number is as follows:AI (17) expiration date 11The GS1 AI (17) indicates that the data field contains an expiration date. The structure of theexpiration date should be as follows: 1011Year: the tens and units of the year (e.g., 2003 03), which is mandatoryMonth: the number of the month (e.g., January 01), which is mandatoryDay: the number of the day of the relevant month (e.g., second day 02); if it is notnecessary to specify the day, the field must be filled with two zerosFor more information, see GS1 General Specifications, Section 3.4.1, Batch or Lot Number: AI (10).For more information, see GS1 General Specifications, Section 3.4.7, Expiration Date: AI (17).11

The format of the expiration date is as follows:AI (21) serial number 12The GS1 AI (21) indicates that the data field contains a serial number. When combined with aGTIN, a serial number uniquely identifies an individual item. The manufacturer determines theserial numbe

For more information, see GS1 AIDC Healthcare Implementation Guideline, Section 3.5.3, Secondary Package. 5. For more information, see GS1 AIDC Healthcare Implementation Guideline, Section 3.5.2, Primary Package. 8 Encoded in the data carrier, these examples will take on the following format: FNC Opening Character AI .

Related Documents:

Bruksanvisning för bilstereo . Bruksanvisning for bilstereo . Instrukcja obsługi samochodowego odtwarzacza stereo . Operating Instructions for Car Stereo . 610-104 . SV . Bruksanvisning i original

Food labelling & Its Importance Labelling includes any written, printed or graphics present on the label, accompanies the food, or is displayed near the food. Food Labelling serves as a primary link of communication between the food manufacturer and consumer. Food labels provide information to help u

10 tips och tricks för att lyckas med ert sap-projekt 20 SAPSANYTT 2/2015 De flesta projektledare känner säkert till Cobb’s paradox. Martin Cobb verkade som CIO för sekretariatet för Treasury Board of Canada 1995 då han ställde frågan

service i Norge och Finland drivs inom ramen för ett enskilt företag (NRK. 1 och Yleisradio), fin ns det i Sverige tre: Ett för tv (Sveriges Television , SVT ), ett för radio (Sveriges Radio , SR ) och ett för utbildnings program (Sveriges Utbildningsradio, UR, vilket till följd av sin begränsade storlek inte återfinns bland de 25 största

Hotell För hotell anges de tre klasserna A/B, C och D. Det betyder att den "normala" standarden C är acceptabel men att motiven för en högre standard är starka. Ljudklass C motsvarar de tidigare normkraven för hotell, ljudklass A/B motsvarar kraven för moderna hotell med hög standard och ljudklass D kan användas vid

LÄS NOGGRANT FÖLJANDE VILLKOR FÖR APPLE DEVELOPER PROGRAM LICENCE . Apple Developer Program License Agreement Syfte Du vill använda Apple-mjukvara (enligt definitionen nedan) för att utveckla en eller flera Applikationer (enligt definitionen nedan) för Apple-märkta produkter. . Applikationer som utvecklas för iOS-produkter, Apple .

2 / 13 INTRODUCTION The White Paper "Medical Devices Labelling: instructions for use" explains from a regulatory point of view what are the labelling requirements of Medical Devices according to the MDR (EU) 2017/745 Regulation. It is mandatory and fundamental to apply the requirements for the labelling of Medical Devices as the information on the product label helps the user to identify .

This presentation and SAP's strategy and possible future developments are subject to change and may be changed by SAP at any time for any reason without notice. This document is 7 provided without a warranty of any kind, either express or implied, including but not limited to, the implied warranties of merchantability, fitness for a .