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VIEWS: 92 PAGES: 100

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									France
Field Name Defintion

US CHeS

Message Product
Function of message

Function indicates if NEW, MODIFY or DELETE Gives Date and Time of message creation. Is automatically generated Effective Date of message / Publication Date 29 / 51 50 / 107

Date and Time of creation

Date begin validity

Gives date of validity of information in Availability Start Date / List pricing dates this message Gives expiry date of validity of information in this messageIndique la date de fin de validité des informations dans ce message List pricing dates

Date end of validity

107

Administrative Information Name of Company issuing information SIRET Name of message sender : manufacturer or distributor Identification of message issuer by its SIRET-Nr (SIRET is a French official company registry) Global Location Number allocated by manufacturer Address of message issuer Additional Address of message issuer City of message issuer ZIP code of message issuer Country of message issuer Target Market country Code ? 7 /104 Manufacturer GLN / Brand Owner GLN 2/3 Manufacturer Name 1

GLN Address 1 Address 2 City ZIP code Country

Trade name (registered or not) or common product Line name allowing to Trade Name of Product identify the product. To be mentioned only if different from Commercial Trade Name of product Product Name as published in Official Register (pharmaceuticals) Commercial Trade Name of product or Name as in catalogue and packaging Short product name for the other health / care products Short product name structured by CIP or ACL Identification code of product (CIP) headed by 3400 as listed in Official Register Product identification code - retail pack or or GTIN13, according recommendation This 13 digits code for retail packs has to be headed by a leading 0 in the message. CAVE : check digit calculation Code of samllest unit of use (plus Code smallest Unit petite unité intègre, PPUI). Equivalent to UCD managed by CIP for pharmaceuticals Can be : Code 39, EAN13, GS1-128, Datamatrix(R), RFID, other or none Unit Descriptor 6 GTIN, GTIN Type, GTIN code 4/13/ 14 Item Description (1000) / 11 / Functional Name / 38 / Description 57 Brand Name / Sub-Brand 8/9 Name

Short Description (30)

10

Type of data carrier

Unit Barcode Labeled Y/N

54

List of AI used in AI datastructure

Supplier Reference Nr

Indiv. Serial Number Required / Lot # 00 SSCC, 01 GTIN 02 Content, 10 Lot Encoded on Product / Nr, 15 best before, 17 Exp Date, 21, Patient Tracing Record Required / Serial # Serial Nr, 37 Quantity included, … Enclosed on Product / SM Encoded on Product Internal Reference of supplier, for Manufacturer Product Number information purpose Defines the distribution channel according regulation; can have following content : Distribution through retail pharmacies Distribution through Hospital Pharmacies Both distribution channel (retail and hospital pharmacies) Distribution with no restriction (not restricted to pharmaceutical distribution) Default : free distribution

8587 / 90 / 91

5

Distribution channel

URL address For pharmaceuticals : official register (RCP, Résumé des caractéristiques du Produit) : Annex to the market authorisation, summarising information Link to technical dataset about therapeutic indication, adverse effect, guideline for use and side effetc. This information targets healthcare professionals. For the other products, technical data. URL address For pharmaceuticals : Annex to the market authorisation, giving indications, adverse effect, guideline Link to leaflet for use and side effects. This information is inserted into the packaging. This information targets patients. For other products, technical user guide. URL address Photos General information Receiver of orders Function of the message receiver (Name mandatory, SIRET Nr optional) Picture to allow visualisation of all faces of the item Product URL 32 Product URL 32 Product URL 32

Company operating logistical Distributing Company distribution (Name mandatory, SIRET Nr optional) Company issuing the invoice (Name mandatory, SIRET Nr optional) For pharmaceuticals : The company is Company to which market autorisation has been issued named in the market authorisation (usually a manufacturer or its representative). (Name mandatory, SIRET Nr optional)

Invoicing Company

Company having legal responsability in France, as : - for pharmaceuticals, company to which market authorisation has been issued, (Name mandatory, SIRET Nr optional) Company is further responsible for vigilance issues (related to regulation Company marketing product, or its representative bodies AFSSAPS, AFSSA, ...) as Pharmacovigilance et Haemovigilance for drugs - for other product categories, company representative for : Medical Device vigilance Bio-vigilance (for which product group?) special vigilance for reactives or cosmetics Manufacturer Company manufacturing the product (Name mandatory, SIRET Nr optional) Company owning the trade name (Name Owner of Trade Name and Country mandatory, SIRET Nr optional) For pharmaceuticals : Date on the Date of market autorisation or parallel import autorisation market autorisation document, or on the AFSSAPS autorisation for parallel import

Publishing date into official register Pour le médicament : Date figurant au (i.e.in France JO, in the US Fed. Journal Officiel concernant Register) l'autorisation de Mise sur le marché

H1 - Human drug, allopathy medicine (Médicament humain allopathique) H2 - Human drug, homeopathy (Médicament humain homéopathique) V1 - Animal Health product, allopathy medicine (Médicament vétérinaire allopathique) V2 - Animal Health product, homeopathy (Médicament vétérinaire homéopathique) H3 - Medical Device H4 - Medical Device for diagnostic in Code Catégorie vitro (DMIV) (Dispositif Médical pour diagnostic In Vitro) H5 - Special Nutrition Product (Diététique spécialisée, DADAP Denrées Alimentaires Destinées à une Alimentation Particulière selon la Directive européenne 89/398 du 3 mai 1989) V5 - Animal nutrition (Alimentation vétérinaire) H6 - Cosmetics ask a manufacturer if there are other terms / categories (type of animals, etc.) H7 - Other product for human use

Code according European Marketing Class Code (EPhMRA) pharmaceutical Marketing Research Association For pharmaceuticals : ATC (Anatomy, Therapeutic, Chemical) code managed Therapeutic Class Code (ATC/CLADIMED) by WHO and mentioned in market autorisation For other healthcare products, CLADIMED code For medical devices : Global Medical Nomenclature Code (GMDN) Classe spécifique de certains types de produits (contention, collier, aiguille, ...) CE Mark Certification class of CE marking Name and code of CE certifying body Device Nomenclature Code managed by CEN Classification defining code for special medical devices as needles, compression devices, etc. cf official regulation class I, IIa, IIb, III According regulation clear text mention on packaging (cf art R5211-16 du CSP Il, est présent physiquement sur le conditionnement) In the case the product underlies an Name and code of an other scheme other certification as : (Nom et code d'une autre norme) NF Norm for radiology, electric Composition devices, dialysis devices Radioactive Y/N 58 UNSPSC (AVP) / GPC Code / UDEX Category 32 / 36 / 37

Code(s) allowing identification of raw materials (active substances, Substance(s) or ingredients/ materials Code excipients, ingredients, major materials) The field set for composition is repeated as many times as there are components Description of raw materials which Substance(s) / Materials Name could impact heavily (DCI for pharmaceuticals) Quanitity and unit of measurement or materials see list published by AFSSAPS Galenic form as published in market Galenic Form autorisation file (see also pharmacopea) Primary packaging, and eventually materials of the packaging as Primary packaging published in market authorisation file example Vial, Tube dictionnary CIP/ACL AV links to ACM disctionnary GS1, AV see PAC 7065 Quantity in primary packaging, as in Quantity in primary packaging market autorisation file; example for a vial : 150 ml Dosage Form 73 ?? Contains Thimerosal / Mercury / PVC-DEHP 7981 Composition 88

Quantity and unit of use Excipient having potential effect Product description

Unit of measurement in primary packaging

Unit of measurement in primary packaging, as in market autorisation file; example for the vial : 150 ml Secondary packaging as in market autorisation file; example box containing a vial 150 ml Number of unit of use per secondary

Secondary packaging

Number of unit of use per secondary packaging

packaging; example for vial = 1; for tooth with 10 steril compresses = 1; for a box with 20 pills = 20 example : for compressing socks, tooth brush, etc Unit of measurement for a specific category of product; example : compressing socks, footwear Example :

Total Quantity of Next Lower Trade Item Level

15

Color of unit of use

Color

75

Size of unit of use

Quantity of unit of measurement 10 cm x 10 cm for a compress for the unit of use : Product Dimensions Dimensions(H,L,l)/ Charrière = CH Unit for dimension and (related to the unit of diamètre/Volume/Weight/Charrièr flow for catheters (Charrière 6 = 1/3 use) e/Gauge of mm x 6 ) Gauge Unit of needles diameter Example :

1625

Unit of measurement for the unit of 10 cm x 10 cm for a compress use : Dimensions(H,L,l)/ Product Dimensions Charrière = CH Unit for dimension and diamètre/Volume/Weight/Charrièr (related to the unit of flow for catheters (Charrière 6 = 1/3 use) e/Gauge of mm x 6 ) Gauge Unit of needles diameter

1625

Reimbursement level (social security)

Reimbursement level (%) as published officially : 15, 35, 65, 100 or 0 if not reimbursed Date of publication in the official

Reimbursement publication date in journal by the social security of official register (JO) reimbursement level (%) Listed in LPPR Is the item listed in the list of Is the item listed in the list of Accepted by collectivité (Y/N)

MEDICARE HCPS Number 56 / / APC Reimbursement 100/ reimbursed products (LPPR), Yes or No Code 101 products accepted by collectivités, as published in the official register (JO) ? Date of publication in the official journal of the agreement by collectivités Level of dangerosity as in market autorisation file (referring to a list) : Liste 1, 2 or narcotic Is one of the substances (DCI) in the product considered as a Psychotrop

Acceptance publication date in official register (JO)

Code Liste

Psychotrop (Y(N)

(seen Vienna convention and requirement to declare stock movements to AFSSAPS annually) Is the product autorised for

Is OTC (Y/N)

marketing / promotion to the public (OTC)?

Autorisation for parallel import

Has the product autorisation for

Target Market country parallel import within European Union ? Code ? Country of origin (for manufacturing

7 /104

Country of origin for parallel import and parallel import), as ISO Norm, alpha-numeric French Market autorisation number French Market autorisation Nr linked National Drug Code AMM for parallel import (NDC) to parallel import autorisation autorisation According Custom Nomenclatura (used EU internal code of the product to define VAT rule in international trade) Does the product have an expiry date (Y/N) Life span of a product having an expiry Life span (Number / time unit) dateDurée de vie du produit lorsqu'il possède une date limite d'utilisation Time unit can be given in day, week, month, year By kits, the life span is calculated Life span after kit manufacturing (Number / time unit) according the component which has the shortes life span As default, the time unit is month For cosmetics, as in EU Directive Life span after opening (Number / time unit) 2003/15/CE from 27 February 2003 article 6c Can be given in day, week, month, year Shelf Life (days) 64 Expiry Managed / Required 72 / 84

55

Expiry Date (Y(N)

Gives minimum temperature to be maintaned during storage Minimun storage temperature Flash Point (temp) / 63/6 Information is mandatory for products Refrigerate / Freeze / Do 6-68 Not Freeze in the cool chain or particularly sensible Gives maximum temperature to be maintaned during storage Maximum storage temperature Information is mandatory for products in the cool chain or particularly When cool chain interrupted, tolerance Special storage instructions sensible Expressed in hours or days at ambiant temperature light sensitive HAN dry environment HAN Do not freeze) Do not fold Special handling instructions Handle with care Do not shuttle Gives minimum temperature to be Minimum transportation temperature maintaned during transport Information is mandatory for products in the cool chain or particularly sensible Expressed in hours Keep Dry Y/N 76

Special Handling Required Y/N

62

Time span associated with minimum temperature during transport

Gives maximum temperature to be Maximum transportation temperature maintaned during transport Information is mandatory for products in the cool chain or particularly sensible Expressed in hours End of validation of defintions by CIP Sterilisation 20 April 2006 ISO Norm Nr …. Example : oxyd of ethylene, steam, radiation... See CE Norms No = sterile product for single use Yes = reusable product, see CE mark class (decontamination protocole, validated by manufacturer) Recycling Criterium linked to environment. Recyclable products, labelled See EU regulation about waist Elimination, destruction Concerns the product and/or its packaging, i.e. for isotherm boxes Type of vigilance for the product (criterium linked to public health Type of Vigilance policy) Example : medical devices vigilance, cosmetics vigilance, reactive vigilance, etc. Package marked as 52Recyclable / Returnable / 53/7 Disposable / Reusable 0/82 Package marked as 52Recyclable / Returnable / 53/8 Reusable 2 Sterile (AVP) / Sanitize prior to use 31 / 71

Time span associated with maximum temperature during transport

Sterilisation method

Decontamination

Phone, fax or email and number of Contact Vigilance person to be contacted in case of vigilance Classification according customs lists UN (example Cytotoxic ) Listed as a product belonging to the Dopping product dopping products and reacting on tests (this list is maintened by Ministries of Sport) Does the product contain blood derivate ? Is the product listed as allowed to have a generic by AFSSAPS ? Is the product listed as a generic by AFSSAPS ? Is the product listed as a generic by AFSSAPS ? CIP Nr of original product as on the list of generics maintained by Is the product listed as "Médicaments d'exception" Is the drug listed as hospital only (RH), hospital prescription (PH), first hospital prescription (PIH), prescription by specialist only (SPE), see definition in Ministerial Rules MSDS Sheet /Hazardous Material Y/N / URL Hazmat Instructions / Product warning / Caustic 5960 / 61 / 77 / 78

Dangerous product

Blood derivate Original with generics Generic Listed generic Market autorisation of the original product Special drug (Médicament d’exception )

Drug with particular prescription rules

Drug with special audit during Drug with special dispensation treatment (see official ministerial document) Special invoicing rule (Rétrocession Product listed as belonging to special ) invoicing rules Belonging to the Orphan Drugs list Orphan Drug managed by EMEA ? Drug replacing market autorisation CIP Nr of previous drug Nr Has the product be delisted of the list Delisted of reimbursement drug list of reimbursed drugs? As from date of de-listing from the Date of de-listing reimbursement list CIP Nr of the new drug (uniquement Drug replaced by market Replaced Item Nr autorisation Nr lors de la suppression de l'article) Withdraw from market Product is no more marketed As from date, when no order will be accedpted for this product Date of withdrawing of market or Date of withdraw of market autorisation by registration autority Reason of withdraw Conditions for returns (AFSSAPS) Table of all possible reasons ?

102

Is expired product returnable to supplier ? Reimbursed systematically Expired product Return rules Reimbursed for less than 3 years lifespan products Conditional reimbursement No reimbursement Time limit for returns after Expiration What is the time limit for returns after expiry date? In number of months What is the time limit for returns before the expiry date. In number of months (0= no return accepted)pas de reprise) Is broken or damaged product returnable Is defect product returnable Price according price list of supplier, without VAT / taxes Price according price list of supplier or its representative, without VAT / Wholesaler price without tax taxes for the wholesalers (= PFHT as listed on the ministerial list or Retail price without tax reimbursed drugs) Price according price list of supplier, without VAT / taxes Published Distributor Price 34

Time limit for returns before Expiration

Broken or damaged product Defect product Price information Hospital price without tax

Public price all tax included

Public price according official publication Price according special tariff if drug belongs to a group where such a special tariff has been published (original - generics) Maximum price for the hospital to be

List Price ?

105

Public price for special reimbursement all tax included

List Price ?

105

Unit dose tariff, without VAT/tax Commercial Conditions VAT Value of global reimbursement position in LPPR (reimbursement list)

reimbursed; this price is published in the official register Are discounts possible or not Value added tax For kits including several components listed individually in the LPPR (reimbursement list). For the componenents, see lines 501 to 513 below For kits including several components listed individually in the LPPR

Overall maximum price as LPPR

(reimbursement list). For the componenents, see lines 501 to 513 below For kits including several components

Overall maximum sale price as LPPR

listed individually in the LPPR (reimbursement list). For the componenents, see lines 501 to 513

below Reimbursement code (code LPPR) code(s) LPPR or TIPS Date of publication of LPPR code in official register

Duration of reimbursement listing Expiry date of reimbursement listing Code for type of service linked to TIPS Reimbursement tariff Date of publication of reimbursement tariff in official register Maximum sales price all tax included Date of publication of maximum sales price in official register Maximum purchase price all tax included Date of publication of maximum purchase price in official register Number of time LPPR code has been repeated Logistical information

en année

Sales Unit : length

Length of the sales unit (number / units in millimeter)

Product Dimensions

Sales Unit : span

Span of the sales unit (number / units in millimeter)

Product Dimensions

1624 / 44 49 / 69 1624 / 44 49 / 69

Sales Unit : high

High of the sales unit (number / units in millimeter)

Product Dimensions

Sales Unit : gross weight

Gross weight with packaging (Number / unit in Gramms) Example : shrink (multipack) Number of sales units included in the intermediate packaging Length of the intermediate packaging (number / units in millimeter)

Product Dimensions

1624 / 44 49 / 69 1624 / 44 49 / 69 2223 1624 / 44 49 / 69 1624 / 44 49 / 69 1624 / 44 49 1624 / 44 49 / 69

Code intermediate packaging Intermediate packaging : total quantity of sales units

Net Content / Net Content UOM

Intermediate packaging : length

Product Dimensions

Intermediate packaging : span

Span of the intermediate packaging (number / units in millimeter)

Product Dimensions

Intermediate packaging : high

High of the intermediate packaging (number / units in millimeter)

Product Dimensions

Intermediate packaging : gross weight

Gross weight with packaging (Number / unit in Gramms)

Product Dimensions

Standard Carton Code Standard Carton Code standard Carton : Number of sales units included CAVE : recommendation is that each logistical level is coded in GTIN13 Number of sales units included in the standard carton Length of the standard carton (number / units in centimeters) Net Content / Net Content UOM 2223 1624 / 44 49 / 69 1624 / 44 49 / 69 1624 / 44 49 / 69 1624 / 44 49 / 69

Standard Carton : length

Product Dimensions

Standard Carton : span

Span of the standard carton (number / units in centimeters)

Product Dimensions

Standard Carton : high

High of the standard carton (number / units in centimeters)

Product Dimensions

Standard Carton : gross weight

Gross weight with packaging (Number / unit in Kilogramms) Code of the standard pallet

Product Dimensions

Standard Palette Code standard Palette : number of standard cartons standard Palette : number of standard cartons by layer

CAVE : recommendation is that each logistical level is coded in GTIN13 Number of standard cartons included in the pallet Number of standard cartons by lawer on the pallet Net Content / Net Content UOM 2223

standard pallet : Number of sales units included Standard pallet : length Standard pallet : span Standard pallet : high Standard pallet : gross weight standard Palette : other information Placement Placement (Y/N) Fields not in CIP document Langage Flavour / Taste Items groupping

Number of sales units included in the standard pallet Length of the standard pallet (number / units in centimeters) Span of the standard pallet (number / units in centimeters) High of the standard pallet (number / units in centimeters) Gross weight with packaging (Number / unit in Kilogramms) Other information about the standard pallet Is the product forseen for a special placement (Y/N) This is a filed listed by more than one source This is a filed listed by more than one source This is a filed listed by more than one source

Net Content / Net Content UOM Product Dimensions Product Dimensions Product Dimensions Product Dimensions

2223 1624 1624 1624 1624

Flavor

93

Product Type

Lead Time Latex

Consumer / Invoice / This is a filed listed by more than one Shipping / Item Base / Item Variable Unit = source Type of Product This is a filed listed by more than one source This is a filed listed by more than one source

39 43

Latex free

30

Minimum Ordering qty Maximum Ordering qty

This is a filed listed by more than one source This is a filed listed by more than one source Parent / Child Quantity Orderable Unit Price UOM (currency) Enclosure restrictions Potency Use Cycle DEA Doctor-on-siteNumber Required Age Gender Fragrance Ergonomic Location Item Status (A/I/M) National Stock Number Alternative UPN (HIBC) 2628 12 35 / 106 65 74 83 89 92 94 95 96 97 98 99

Maximum Order Quantity 103

France
Field Name Defintion

Message Product
Function of message Date and Time of creation

Function indicates if NEW, MODIFY or DELETE Gives Date and Time of message creation. Is automatically generated

Date begin validity

Gives date of validity of information in this message

Date end of validity

Gives expiry date of validity of information in this messageIndique la date de fin de validité des informations dans ce message

Administrative Information

Name of Company issuing information

Name of message sender : manufacturer or distributor

SIRET GLN

Identification of message issuer by its SIRET-Nr (SIRET is a French official Global Location Number allocated by manufacturer

Address 1 Address 2 City ZIP code Country

Address of message issuer Additional Address of message issuer City of message issuer ZIP code of message issuer Country of message issuer

Trade Name of Product

Trade name (registered or not) or common product Line name allowing to identify the product. To be mentioned only if different from Commercial

Trade Name of product Commercial Trade Name of product Product Name as published in Official Register (pharmaceuticals) or Name as in catalogue and packaging for Short product name the other health / care products Short product name structured by CIP or ACL Product identification code - retail pack Identification code of product (CIP) headed by 3400 as listed in Official Register or or GTIN13, according recommendation This 13 digits code for retail packs has to be headed by a leading 0 in the message. CAVE : check digit calculation

Code smallest Unit

Code of samllest unit of use (plus petite unité intègre, PPUI). Equivalent to UCD managed by CIP for pharmaceuticals Can be : Code 39, EAN13, GS1-128, Datamatrix(R), RFID, other or none

Type of data carrier

List of AI used in AI datastructure

00 SSCC, 01 GTIN 02 Content, 10 Lot Nr, 15 best before, 17 Exp Date, 21, Serial Nr, 37 Quantity included, …

Supplier Reference Nr

Internal Reference of supplier, for information purpose

Distribution channel

Defines the distribution channel according regulation; can have following content : Distribution through retail pharmacies Distribution through Hospital Pharmacies Both distribution channel (retail and hospital pharmacies) Distribution with no restriction (not restricted to pharmaceutical distribution) Default : free distribution

Link to technical dataset

URL address For pharmaceuticals : official register (RCP, Résumé des caractéristiques du Produit) : Annex to the market authorisation, summarising information about therapeutic indication, adverse effect, guideline for use and side effetc. This information targets healthcare professionals. For the other products, technical data.

Link to leaflet

URL address For pharmaceuticals : Annex to the market authorisation, giving indications, adverse effect, guideline for use and side effects. This information is inserted into the packaging. This information targets patients. For other products, technical user guide. URL address Picture to allow visualisation of all faces of the item Function of the message receiver (Name mandatory, SIRET Nr optional)

Photos

General information Receiver of orders

Distributing Company

Company operating logistical distribution (Name mandatory, SIRET Nr optional) Company issuing the invoice (Name mandatory, SIRET Nr optional) For pharmaceuticals : The company is named in the market authorisation (usually a manufacturer or its representative). (Name mandatory, SIRET Nr optional)

Invoicing Company Company to which market autorisation has been issued

Company marketing product, or its representative

Company having legal responsability in France, as : - for pharmaceuticals, company to which market authorisation has been issued, (Name mandatory, SIRET Nr optional) Company is further responsible for vigilance issues (related to regulation bodies AFSSAPS, AFSSA, ...) as Pharmacovigilance et Haemovigilance for drugs - for other product categories, company representative for : Medical Device vigilance Bio-vigilance (for which product group?) special vigilance for reactives or cosmetics

Manufacturer

Company manufacturing the product (Name mandatory, SIRET Nr optional)

Owner of Trade Name

Company owning the trade name (Name and Country mandatory, SIRET Nr optional) For pharmaceuticals : Date on the market autorisation document, or on the AFSSAPS autorisation for parallel import

Date of market autorisation or parallel import autorisation

Publishing date into official register Pour le médicament : Date figurant au (i.e.in France JO, in the US Fed. Journal Officiel concernant Register) l'autorisation de Mise sur le marché Code Catégorie H1 - Human drug, allopathy medicine (Médicament humain allopathique) H2 - Human drug, homeopathy (Médicament humain homéopathique) V1 - Animal Health product, allopathy medicine (Médicament vétérinaire allopathique) V2 - Animal Health product, homeopathy (Médicament vétérinaire Marketing Class Code (EPhMRA) homéopathique) Code according European pharmaceutical Marketing Research Association Therapeutic Class Code (ATC/CLADIMED) For pharmaceuticals : ATC (Anatomy, Therapeutic, Chemical) code managed by WHO and mentioned in market autorisation For other healthcare products, Nomenclature Code (GMDN) CLADIMED code For medical devices : Global Medical Device Nomenclature Code managed by CEN Classe spécifique de certains types de produits (contention, collier, aiguille, ...) CE Mark Certification class of CE marking Name and code of CE certifying body Classification defining code for special medical devices as needles, compression devices, etc. cf official regulation class I, IIa, IIb, III According regulation clear text mention on packaging (cf art R5211-16 du CSP Il, est présent physiquement Name and code of an other scheme (Nom et code d'une autre norme) sur le conditionnement) In the case the product underlies an other certification as : NF Norm for radiology, electric Composition devices, dialysis devices

Substance(s) or ingredients/ materials Code

Code(s) allowing identification of raw materials (active substances, excipients, ingredients, major materials) The field set for composition is repeated as many times as there are components Description of raw materials which could impact heavily (DCI for pharmaceuticals) Quanitity and unit of measurement or materials see list published by AFSSAPS

Substance(s) / Materials Name

Quantity and unit of use Excipient having potential effect

Product description Galenic Form Galenic form as published in market autorisation file (see also Primary packaging pharmacopea) Primary packaging, and eventually materials of the packaging as published in market authorisation file example Vial, Tube dictionnary CIP/ACL AV links to ACM Quantity in primary packaging disctionnary GS1, AV see PAC 7065 Quantity in primary packaging, as in market autorisation file; example for a vial : 150 ml Unit of measurement in primary packaging Secondary packaging Unit of measurement in primary packaging, as in market autorisation file; example for the vial : 150 ml Secondary packaging as in market autorisation file; example box containing a vial 150 ml

Number of unit of use per secondary packaging

Number of unit of use per secondary packaging; example for vial = 1; for tooth with 10 steril compresses = 1; for a box with 20 pills = 20

Color of unit of use

example : for compressing socks, tooth brush, etc

Size of unit of use

Unit of measurement for a specific category of product; example :

compressing socks, footwear Quantity of unit of measurement for Example : the unit of use : Dimensions(H,L,l)/ 10 cm x 10 cm for a compress diamètre/Volume/Weight/Charrièr Charrière = CH Unit for dimension and e/Gauge flow for catheters (Charrière 6 = 1/3 of mm x 6 ) Gauge Unit of needles diameter Unit of measurement for the unit of Example : use : Dimensions(H,L,l)/ 10 cm x 10 cm for a compress diamètre/Volume/Weight/Charrièr Charrière = CH Unit for dimension and e/Gauge flow for catheters (Charrière 6 = 1/3 of mm x 6 ) Reimbursement level (social security) Reimbursement publication date in official register (JO) Listed in LPPR Gauge Unit of needles diameter Reimbursement level (%) as published officially : 15, 35, 65, 100 or 0 if not reimbursed Date of publication in the official journal by the social security of reimbursement level (%) Is the item listed in the list of reimbursed products (LPPR), Yes or No Accepted by collectivité (Y/N) Is the item listed in the list of products accepted by collectivités, as published in the official register (JO) Acceptance publication date in official register (JO) Code Liste ? Date of publication in the official journal of the agreement by collectivités Level of dangerosity as in market autorisation file (referring to a list) : Liste 1, 2 or narcotic

Psychotrop (Y(N)

Is one of the substances (DCI) in the product considered as a Psychotrop (seen Vienna convention and requirement to declare stock movements to AFSSAPS annually) Is the product autorised for marketing / promotion to the public (OTC)? Has the product autorisation for parallel import within European Union ?

Is OTC (Y/N)

Autorisation for parallel import

Country of origin for parallel import Country of origin (for manufacturing and parallel import), as ISO Norm, alpha-numeric French Market autorisation number French Market autorisation Nr linked AMM for parallel import autorisation to parallel import autorisation EU internal code of the product According Custom Nomenclatura (used to define VAT rule in international Expiry Date (Y(N) Life span (Number / time unit) trade) Does the product have an expiry date (Y/N) Life span of a product having an expiry dateDurée de vie du produit lorsqu'il possède une date limite d'utilisation Time unit can be given in day, week, month, year Life span after kit manufacturing (Number / time unit) By kits, the life span is calculated according the component which has the shortes life span As default, the time unit is month Life span after opening (Number / time unit) For cosmetics, as in EU Directive 2003/15/CE from 27 February 2003 article 6c Can be given in day, week, month, year

Minimun storage temperature

Gives minimum temperature to be maintaned during storage Information is mandatory for products in the cool chain or particularly sensible Gives maximum temperature to be maintaned during storage Information is mandatory for products in the cool chain or particularly sensible Expressed in hours or days at ambiant temperature light sensitive HAN dry environment HAN Do not freeze) Do not fold Handle with care Do not shuttle Gives minimum temperature to be maintaned during transport Information is mandatory for products in the cool chain or particularly sensible Expressed in hours

Maximum storage temperature

When cool chain interrupted, tolerance Special storage instructions

Special handling instructions

Minimum transportation temperature

Time span associated with minimum temperature during transport Maximum transportation temperature

Gives maximum temperature to be maintaned during transport Information is mandatory for products in the cool chain or particularly sensible Expressed in hours

Time span associated with maximum temperature during transport Sterilisation

End of validation of defintions by CIP 20 April 2006 ISO Norm Nr …. Example : oxyd of ethylene, steam, radiation... See CE Norms

Sterilisation method

Decontamination

No = sterile product for single use Yes = reusable product, see CE mark class (decontamination protocole, validated by manufacturer) Criterium linked to environment. Recyclable products, labelled

Recycling

Elimination, destruction

See EU regulation about waist Concerns the product and/or its packaging, i.e. for isotherm boxes Type of vigilance for the product (criterium linked to public health policy) Example : medical devices vigilance, cosmetics vigilance, reactive vigilance, etc. Phone, fax or email and number of person to be contacted in case of vigilance Classification according customs lists UN (example Cytotoxic )

Type of Vigilance

Contact Vigilance

Dangerous product

Dopping product

Listed as a product belonging to the dopping products and reacting on tests (this list is maintened by Ministries of Sport) Does the product contain blood derivate ?

Blood derivate

Original with generics

Is the product listed as allowed to have a generic by AFSSAPS ?

Generic

Is the product listed as a generic by AFSSAPS ?

Listed generic

Is the product listed as a generic by AFSSAPS ?

Market autorisation of the original product

CIP Nr of original product as on the list of generics maintained by

Special drug (Médicament d’exception )

Is the product listed as "Médicaments d'exception"

Drug with particular prescription rules

Is the drug listed as hospital only (RH), hospital prescription (PH), first hospital prescription (PIH), prescription by specialist only (SPE), see definition in Ministerial Rules Drug with special audit during treatment (see official ministerial document)

Drug with special dispensation

Special invoicing rule (Rétrocession Product listed as belonging to special ) invoicing rules

Orphan Drug

Belonging to the Orphan Drugs list managed by EMEA ?

Drug replacing market autorisation Nr

CIP Nr of previous drug

Delisted of reimbursement drug list Has the product be delisted of the list of reimbursed drugs?

Date of de-listing

As from date of de-listing from the reimbursement list

Drug replaced by market autorisation Nr

CIP Nr of the new drug (uniquement lors de la suppression de l'article)

Withdraw from market Date of withdrawing of market

Product is no more marketed As from date, when no order will be accedpted for this product or Date of withdraw of market autorisation by registration autority (AFSSAPS)

Reason of withdraw Conditions for returns Expired product Return rules

Table of all possible reasons ? Is expired product returnable to supplier ? Reimbursed systematically Reimbursed for less than 3 years lifespan products Conditional reimbursement No reimbursement

Time limit for returns after Expiration

What is the time limit for returns after expiry date? In number of months

Time limit for returns before Expiration

What is the time limit for returns before the expiry date. In number of months (0= no return accepted)pas de reprise) Is broken or damaged product returnable Is defect product returnable Price according price list of supplier, without VAT / taxes Price according price list of supplier or its representative, without VAT / taxes for the wholesalers (= PFHT as listed on the ministerial list or reimbursed drugs) Price according price list of supplier, without VAT / taxes Public price according official publication Price according special tariff if drug belongs to a group where such a special tariff has been published (original generics) Maximum price for the hospital to be reimbursed; this price is published in the official register Are discounts possible or not Value added tax For kits including several components listed individually in the LPPR (reimbursement list). For the componenents, see lines 501 to 513 below For kits including several components listed individually in the LPPR (reimbursement list). For the componenents, see lines 501 to 513 below

Broken or damaged product Defect product Price information Hospital price without tax Wholesaler price without tax

Retail price without tax Public price all tax included Public price for special reimbursement all tax included

Unit dose tariff, without VAT/tax

Commercial Conditions VAT Value of global reimbursement position in LPPR (reimbursement list)

Overall maximum price as LPPR

Overall maximum sale price as LPPR

For kits including several components listed individually in the LPPR (reimbursement list). For the componenents, see lines 501 to 513 below code(s) LPPR or TIPS

Reimbursement code (code LPPR) Date of publication of LPPR code in official register Duration of reimbursement listing Expiry date of reimbursement listing Code for type of service linked to TIPS Reimbursement tariff Date of publication of reimbursement tariff in official register Maximum sales price all tax included Date of publication of maximum sales price in official register Maximum purchase price all tax included Date of publication of maximum purchase price in official register Number of time LPPR code has been repeated Logistical information Sales Unit : length

en année

Length of the sales unit (number / units in millimeter)

Sales Unit : span

Span of the sales unit (number / units in millimeter)

Sales Unit : high

High of the sales unit (number / units in millimeter)

Sales Unit : gross weight

Gross weight with packaging (Number / unit in Gramms)

Code intermediate packaging Intermediate packaging : total quantity of sales units Intermediate packaging : length

Example : shrink (multipack) Number of sales units included in the intermediate packaging Length of the intermediate packaging (number / units in millimeter)

Intermediate packaging : span

Span of the intermediate packaging (number / units in millimeter)

Intermediate packaging : high

High of the intermediate packaging (number / units in millimeter)

Intermediate packaging : gross weight

Gross weight with packaging (Number / unit in Gramms)

Standard Carton Code

Standard Carton Code CAVE : recommendation is that each logistical level is coded in GTIN13 Number of sales units included in the standard carton Length of the standard carton (number / units in centimeters)

standard Carton : Number of sales units included Standard Carton : length

Standard Carton : span

Span of the standard carton (number / units in centimeters)

Standard Carton : high

High of the standard carton (number / units in centimeters)

Standard Carton : gross weight

Gross weight with packaging (Number / unit in Kilogramms)

Standard Palette Code

Code of the standard pallet CAVE : recommendation is that each logistical level is coded in GTIN13 Number of standard cartons included in the pallet Number of standard cartons by lawer on the pallet Number of sales units included in the standard pallet Length of the standard pallet (number / units in centimeters) Span of the standard pallet (number / units in centimeters) High of the standard pallet (number / units in centimeters) Gross weight with packaging

standard Palette : number of standard cartons standard Palette : number of standard cartons by layer standard pallet : Number of sales units included Standard pallet : length Standard pallet : span Standard pallet : high Standard pallet : gross weight

(Number / unit in Kilogramms) standard Palette : other information Other information about the standard pallet Placement Placement (Y/N) Fields not in CIP document Langage Flavour / Taste Items groupping Product Type Is the product forseen for a special placement (Y/N) This is a filed listed by more than one source This is a filed listed by more than one source This is a filed listed by more than one source This is a filed listed by more than one source Lead Time Latex Minimum Ordering qty Maximum Ordering qty This is a filed listed by more than one source This is a filed listed by more than one source This is a filed listed by more than one source This is a filed listed by more than one source

US CHeS

US DoD

Consolidated US CHeS

Effective Date of message / Publication Date Availability Start Date / List pricing dates

29 / 51 50 / Product effective date 107 A.29 Effective Date (of the submitted product record) & Publication Date to Authorized Parties & Availability Start Date A.29, B.16, B.15, C.11

List pricing dates

107

We believe some additional questions need to be answere Market Dependent that applies. (Note our responses only body for this product - e.g. FDA. 3) Trading Partners Sp sold in the US market. Not all products have the same re related to other markets, regulators and/or trading partne issues in other sectors - we look to existing practices for g Manufacturer Name 1 Manufacturer GLN / Brand Owner GLN A.1 A.2, A.3

Manufacturer GLN / Brand Owner GLN

2/3

Manufacturer GLN / Brand Owner GLN

A.1 A.2, A.3

Target Market country Code ?

7 /104

Brand Name / Sub-Brand 8 / 9 Name

Brand Name / SubBrand Name

A.8, A.9

Item Description (1000) / 11 / Product description 1000 Functional Name / 38 / Description 57

8

Item Description (1000)

A.11

Short Description (30)

10

Product description 30

7

GTIN, GTIN Type, GTIN code

4/13/ Unit UPC 14

9

Short Description (70), A.10, Abbreviated C.56 Description (30) GTIN, GTIN Type, A.4, A.13, GTIN code A.14

Unit Descriptor

6

Each GTIN

15

Unit Descriptor

A.6

Unit Barcode Labeled Y/N

54

Unit Bar code labeled Y/N

11

Unit Barcode Labeled Y/N

C.12

Indiv. Serial Number 85- Expiry BC RFID tag Y/N Required / Lot # 87 / Individual serial nb Seria Encoded on Product / 90 / nb encoded Y/N - lot nb Patient Tracing Record 91 required Y/N lot nb Required / Serial # encoded Y/N - patient Enclosed on Product / SM tracking required Y/N Encoded on Product

56/58/ Indiv. Serial Number 59/60/ Required / Lot # 61 - 62 Encoded on Product / Patient Tracing Record Required / Serial # Enclosed on Product / SM Encoded on Product 6 Manufacturer Product Number

C.43, C.44, C.45, C.48, C.49

Manufacturer Product Number

5

Manufacturer item

A. 5

Product URL

32

Product URL

63

Product URL

A.32

Product URL

32

Product URL

32

Product URL

A.32

Manufacturer GLN / Brand Owner GLN

A.1 A.2, A.3

Manufacturer GLN / Brand Owner GLN

A.1 A.2, A.3

Manufacturer common name + GLN Product brand name

3/4

Manufacturer Name

A.1 A.2, A.3 A.1 A.2, A.3

5

Manufacturer GLN / Brand Owner GLN

UDEX Category, UNSPSC A.33 B.2,

UNSPSC (AVP) / GPC Code / UDEX Category

32 / UNSPSC 36 / 37

29

UDEX Category, UNSPSC A.33 B.2,

Radioactive Y/N

58

Radioactive Y/N

C.16

Composition

88

Item active Y/N

41

Composition

C.46

Composition

C.46

?? Contains Thimerosal / Mercury / PVC-DEHP

7981

Cautic/Contains Thimerosal / Contains Mercury / Contains PVC-DEHP/Contains Latex

C.36, C.37, C.38, C.39, A.30

Dosage Form

73

Dosage Form, Potency C.31, C32

Unit UPC

9

Orderable Unit/ Global Trade Item Number (UPC) Type/Global Trade Item Number (UPC) Code

A. 12, A.13, A.14,

Each content Count

13

Net Content / Net Content UOM Unit Descriptor

A.13

Unit UPC UOM

10

A.6

Pack GTIN

Child Internal Identifier/ Total Quantity of Next Lower Trade Item/Net Content / Net Content UOM

A.27, A.15, A.22, A.23

Total Quantity of Next Lower Trade Item Level

15

Color

75

Child Internal Identifier/ Total Quantity of Next Lower Trade Item/Net Content / Net Content UOM Color

A.27, A.15, A.22, A.23

B.33

Each weight, height, lenght, Product Dimensions (related to the unit of use) 16- Each content count 25

18-21

13

Product Dimensions (related to the unit of use)

16-25

Product Dimensions (related to the unit of use)

16- cf 61 25

Product Dimensions (related to the unit of use)

16-25

MEDICARE HCPS Number 56 / / APC Reimbursement 100/ Code 101

MEDICARE HCPS Number / APC Reimbursement Code

56 / 100/101

Target Market country Code ?

7 /104

Target Market country Code

7 /104

National Drug Code (NDC)

55

National Drug Code (NDC)

55

Expiry Managed / Required Shelf Life (days)

72 / Expiration date rquired 84 Y/N 64

55

Expiry Managed / Required Shelf Life (days)

72 / 84 64

Flash Point (temp) / 63/6 Refrigerate / Freeze / Do 6-68 Not Freeze

Flash Point (temp) / Refrigerate / Freeze / Do Not Freeze

63/66-68

Keep Dry Y/N

76

Keep Dry Y/N

76

Special Handling Required Y/N

62

Special handling required Y/N

45

Special Handling Required Y/N

62

Sterile (AVP) / Sanitize prior to use

31 / Sterile 71

49

Sterile (AVP) / Sanitize prior to use

31 / 71

Package marked as 52- reusable Recyclable / Returnable / 53/7 Disposable / Reusable 0/82 Package marked as 52- Disposal instruction Y/N Recyclable / Returnable / 53/8 Reusable 2

54

47

Package marked as Recyclable / Returnable / Disposable / Reusable Package marked as Recyclable / Returnable / Reusable

5253/70/82

52-53/82

MSDS Sheet /Hazardous Material Y/N / URL Hazmat Instructions / Product warning / Caustic

59- MSDS sheet Y/N / 60 / Hazardous material 61 / 77 / 78

46 / 48 MSDS Sheet /Hazardous Material Y/N / URL Hazmat Instructions / Product warning / Caustic

59-60 / 61 / 77 / 78

Replaced Item Nr

102

Replaced Item Nr

102

Published Distributor Price

34

Published Distributor Price

34

List Price ? List Price ?

105 105

List Price ? List Price ?

105 105

Product Dimensions

Product Dimensions

Product Dimensions

Product Dimensions

1624 / 44 49 / 69 1624 / 44 49 / 69 1624 / 44 49 / 69 1624 / 44 49 / 69

Product Dimensions

16-24 / 44 - 49 / 69

Product Dimensions

16-24 / 44 - 49 / 69

Product Dimensions

16-24 / 44 - 49 / 69

Product Dimensions

16-24 / 44 - 49 / 69

Pack GTIN Net Content / Net Content UOM Product Dimensions 22- Pack Each count 23 16- Pack lenght 24 / 44 49 / 69 1624 / 44 49 / 69 16- Pack height 24 / 44 49 16- Pack weight 24 / 44 49 / 69 Case GTIN

25 24 Net Content / Net Content UOM 22-23 16-24 / 44 - 49 / 69

28-23 Product Dimensions

Product Dimensions

Product Dimensions

16-24 / 44 - 49 / 69

Product Dimensions

26-23 Product Dimensions

16-24 / 44 - 49

Product Dimensions

29-23 Product Dimensions

16-24 / 44 - 49 / 69

33

Net Content / Net Content UOM Product Dimensions

22- Case each count 23 16- Case lenght 24 / 44 49 / 69 1624 / 44 49 / 69 16- Case height 24 / 44 49 / 69 16- Case weight 24 / 44 49 / 69

32

Net Content / Net Content UOM

22-23 16-24 / 44 - 49 / 69

36-31 Product Dimensions

Product Dimensions

Product Dimensions

16-24 / 44 - 49 / 69

Product Dimensions

34-31 Product Dimensions

16-24 / 44 - 49 / 69

Product Dimensions

37-31 Product Dimensions

16-24 / 44 - 49 / 69

Net Content / Net Content UOM

2223

Net Content / Net Content UOM

22-23

Net Content / Net Content UOM Product Dimensions Product Dimensions Product Dimensions Product Dimensions

2223 1624 1624 1624 1624

Net Content / Net Content UOM Product Dimensions Product Dimensions Product Dimensions Product Dimensions

22-23 16-24 16-24 16-24 16-24

Flavor

93

Flavor

93

Consumer / Invoice / Shipping / Item Base / Item Variable Unit = Type of Product

39 43

Consumer / Invoice / Shipping / Item Base / Item Variable Unit = Type of Product

39 - 43

Latex free

30

Latex free Y/N

50

Latex free

30

Parent / Child Quantity

26- Pack width 28

27

Parent / Child Quantity

26-28

Orderable Unit Price UOM (currency) Enclosure restrictions Potency Use Cycle DEA Doctor-on-siteNumber Required Age Gender Fragrance Ergonomic Location Item Status (A/I/M) National Stock Number Alternative UPN (HIBC) Maximum Order Quantity

Case shippable by manufacturer 35 / First orde date 106 65 First ship date 74 EACH shippable by manufacturer 83 Contain thimerosal Y/N 89 Contain mercury Y/N 92 94 95 96 97 98 99 103 Contain PVC/DEPH Y/N DEA Doctor on site nb required Y/N

12

38 43 44 22 51 52 53 57

Orderable Unit Price UOM (currency) Enclosure restrictions Potency Use Cycle DEA Doctor-on-siteNumber Required Age Gender Fragrance Ergonomic Location Item Status (A/I/M) National Stock Number Alternative UPN (HIBC) Maximum Order Quantity

12 35 / 106 65 74 83 89 92 94 95 96 97 98 99 103

Comments - PLH

This set of fields relate to the control and update of product records submitted and available in the Data Pool Data Pool Process control: Should follow existing GDSN Pool standards

Should follow existing GDSN Pool standards Multiple distinct effective dates are needed: 1) Effective date of product record 2) Date of Publishing 3) Product Availability Start Date 4) List Price Date

Multiple Expiration Dates Needed - not defined in US Data set, but should pair with effective dates and follow existing GDSN Pool standards

tional questions need to be answered that drive the relevancy of responses: 1) Target at applies. (Note our responses only relate to the target market of the U.S. 2) Regulating - e.g. FDA. 3) Trading Partners Specific. We are responding to conditions of product Not all products have the same requirements Same products may carry different data ets, regulators and/or trading partner requirements. GDSN currently deals with these - we look to existing practices for guidance on the best ways to handle this. We interpret this to be the name of the authorized entity that is submitting the information to the pool - could be the manufacturer, or a surrogate for the manufacturer. Agree identification is needed. Already addressed in GDSN. We assume the message sender, the manufacturer and the Brand Owner are potentially the same or different entities. Identification should be made for each following GDSN identification standards. Target Market and Regulation dependent Not clear. Is this to be the identification of the submitter of information(Authorized surrogate) or the originating Product owner (Manufacturer). Should follow existing GDSN standards Should follow existing GDSN Pool standards - Address information in Registry Should follow existing GDSN Pool standards - Address information in Registry Should follow existing GDSN Pool standards - Address information in Registry Should follow existing GDSN Pool standards - Address information in Registry Should follow existing GDSN Pool standards - Address information in Registry

GLN GLN GLN GLN GLN

We interpret this to mean the Brand Name commonly used to describe this product.

These could be two separate fields: 1) Registered Trade Name (only required for registered/regulated products if different from Brank Name may be target market dependent) 2) Catalog Item Long Description (1000 characters) as currently defined in the GDSN. U.S. has only identified the catalog description field as needed - not necessarily the legal/registered description There should be two short description fields: 1) Existing GDSN Field 70 characters and 2) Abbreviated Short Description 30 characters to satisfy US common practices and data base limitations Depending on the item, it may be a retail package or not. We believe this should follow existing GDSN standards which are quite robust and specific.

coding set should match approved and commonly used standards currently in the GDSN US markets plus US FDA pharma standard units if those are not already in the GDSN standard data set This should describe the code standard used on the package for electronic identification. Our recommendation is that in submission, the product information answers two questions: 1) Is there electronic coding on the product, 2) what type of coding is it (RFID nd/or Bar Code) 3) what code standard applies. Again, these issues are largely addressed in other industry sectors of the GDSN. Our mapping does not go to this detail - we look to guidance from othe GDSN sectors. Our recommendation is that several key questions should be addressed. These fields may may or may not be required depending on target market and the regulatory body. Data structure should allow one or more items may apply to a product. We see that there is a need for two types on information: 1) What level of tracking data is provided on the product (Lot #, Serial #). 2) What Tracking is required regarding its sale or use (eg Patient Tracking Record), 3) What linformation labelliing data is provided/required on the product (e.g. Best Before Date, Expiration Date, etc.)

If the Product data requires that we have the ability to indicate the allowable Distribution Channels for a given product (not identified as a high priority at this point), then it is necessary to answer two questions: 1) Who can purchase: eg can this product be purchased by an individual consumer, by any business, by a licensed healthcare provider, by a licensed In-patient hospital/facility? and, 2) What type of sales channels is allowed for that type of purchaser? For example: If purchaseable by a consumer, and it is a pharma product allowable channels might be only retail pharmacy or hospital pharmacy. Currently ISO codes exist fthat define or Target Market Channels - these may be useable for this purpose.

We have identified one URL to be the manufacturer's product information URL, at this time we envision that this URL would link to the manufacturer who would in turn provide additional links to other sites or information that are relevant to the product. See next item

This is target market and regulatory dependent. Since Detail Pharma was out of scope we have not included the equivalent of the regulatory "leaflet". In the US market, pharma data is widely accessed using other datapools that provide a great deal of data such as First Data Bank. However, our TAG group has discussed this area and can see the potential use for links to one or more official federal registries depending on the regulation that apply to the product. This needs to be further explored and adapted as the FDA requirements change over time. We agree with inclusion as an optional field at this time Through Manufacturer URL - not averse to including as an added field

Trading Partner Specific - not included in the U.S. data set. Review GDSN Pool processes and standards of communications

Trading Partner Specific - not included in the U.S. data set. Review GDSN Pool processes and standards of communications Trading Partner Specific - not included in the U.S. data set. Review GDSN Pool processes and standards of communications France STRET ID would be local Requirement - Not applicable to US as described - For Regulated Products in a Target Market: Officially registered Manufacturer/Labeler/Brand Owner. Has not been requested by Supply Chain, but should be considered. The name and ID may differ in different target markets. We can see a purpose for this under some circumstances.

France Requirement - Not applicable to US as described - For Regulated Products in a Target Market: Officially registered Manufacturer/Labeler/Brand Owner. Has not been requested by Supply Chain, but should be considered. The name and ID may differ in different target markets. We can see a purpose for this under some circumstances.

Target Market and Regulation dependent - Consider GDSN current approach in other industries

Target Market and Regulation dependent - Consider GDSN current approach in other industries This relates to product classification. We believe that product classification should be structured to allow for two answers: 1) What classification Schema is used (UNSPSC, UDEX, etc.) and for each classification code Schema the corresponding product classification code. A single product may require more than one classification code to be applied for regulatory or other market reasons. In the U.S. We re recommending moving towards the use of the UNSPSC Classification system to the commodity code level whereever it can be applied. Product Regulations and target markets may determine which and how many classifications will be part of the product record.

Does not apply to US Target Market - See response to 39 above. We believe that the healthcare sector will require the ability to code products following different standards based on the target market, target market regulations, and the product type/category in that market. See response to 39 above. We believe that the healthcare sector will require the ability to code products following different standards based on the target market , target market regulations, and the product type/category in that market.

This area is under review currently by the FDA. See response to 39 above. We believe that the healthcare sector will require the ability to code products following different standards based on the target market , target market regulations, and the product type/category in that market. See response to 39 above. We believe that the healthcare sector will require the ability to code products following different standards based on the target market , target market regulations, and the product type/category in that market. Does not apply to US Target Market Does not apply to US Target Market Does not apply to US Target Market

We have identified a number of fields that relate to special hazzards for material handling, storage, disposition that should be addressed. The GDSN already addresses most of these considerations in other product sectors.

Unstructure descriptive field - no coding or structure has been defined at this time. In the area of Pharma, the US market has not identified a need at this time for moving large quantities of product detail attributes to the GDSN since they are readily available from other sources. We have not identified a specific coding schema for this purpose. These requirements will depend on regulations and target markets. It should be noted that coding does exists in the GDSN for many materials - we would look to guidance on what has already been defined. Unstructure descriptive text field - no coding or structure has been defined

Not required at this time. These are several materials that are of concern for environmental or usage impact reasons (e.g. allergy) in the US market. It should be noted that the GDSN already addresses a structure where these types of codes either exist or could fit.

US market will following existing GDSN guidelines and standards - if coding extensions are needed for any units of measure, we will recommend those additions

US market will following existing GDSN guidelines and standards - if coding extensions are needed for any units of measure, we will recommend those additions US market will following existing GDSN guidelines and standards - if coding extensions are needed for any units of measure, we will recommend those additions US market will following existing GDSN guidelines and standards - if coding extensions are needed for any units of measure, we will recommend those additions

US market will following existing GDSN guidelines and standards - if coding extensions are needed for any units of measure, we will recommend those additions

US market will following existing GDSN guidelines and standards - if coding extensions are needed for any units of measure, we will recommend those additions US market will following existing GDSN guidelines and standards - if coding extensions are needed for any units of measure, we will recommend those additions The example given provides clinical use dimensions - the US market at this time is only identifying storage/exterior product dimension. This information may be embeddedin the product description 1000 character field or will be carried in the product URL. We are not planning to add this information in the near term

The example given provides clinical use dimensions - the US market at this time is only identifying storage/exterior product dimension. This information may be embeddedin the product description 1000 character field or will be carried in the product URL. We are not planning to add this information in the near term

Not applicable for the US Target Market

Not applicable for the US Target Market

Not applicable for the US Target Market

Not applicable for the US Target Market

Not applicable for the US Target Market

Not applicable at this time: Again, pharma regulatory information is currently carried separately and may be accessible via the product URL.

Not applicable at this time: Again, pharma regulatory information is currently carried separately and may be accessible via the product URL.

Addressed earlier under distribution channel line #

Not applicable for the US Target Market - Look to GDSN guidance on how this is handled in other industry sectors when a US manufacturer exports to the EU as a target market Look to GDSN guidance on how this is handled in other industry sectors

Not applicable for the US Target market - if this is a governmentally assigned product ID, it's US equivalent might be the assigned NDC code. See response to product identification line # Not applicable for the US Target Market - Look to GDSN guidance on how this is handled in other industry sectors when a US manufacturer exports to the EU or other countries as a target market

Most common unit is days but can be extended to other units - look to GDSN guidance from other sectors where this also applies

Kits are widely used in the US healthcare market, but are most often custom configurations that would not be egistered in the Data Pool. At this time kits are being treated as single products rather than as a configuration of multiple products. More robust kit data may be a future consideration.for those kits that are to be added to the Data Pool as products. Not applicable for the US Target Market - Look to GDSN guidance on how this is handled in other industry sectors when a US manufacturer exports to the EU as a target market

These elements have already been addressed in other GDSN industry sectors - we look there for guidance.

These elements have already been addressed in other GDSN industry sectors - we look there for guidance.

T/B/D These or related conditions have already been addressed in other GDSN industry sectors - we look there for guidance. These or related conditions have already been addressed in other GDSN industry sectors - we look there for guidance. These or related conditions have already been addressed in other GDSN industry sectors - we look there for guidance.

These or related conditions have already been addressed in other GDSN industry sectors - we look there for guidance. These or related conditions have already been addressed in other GDSN industry sectors - we look there for guidance.

These or related conditions have already been addressed in other GDSN industry sectors - we look there for guidance.

This field appears to add additional instructions or conditions to the sterilization/sanitization requirements and condition of the product - there may be regulatory or target market requirements - needs further discussion.

These or related conditions may have already been addressed in other GDSN industry sectors - we look there for guidance.

These or related conditions have already been addressed in other GDSN industry sectors - we look there for guidance.

These or related conditions have already been addressed in other GDSN industry sectors - we look there for guidance. We would interpret this as equivalent to answering the regulatory body may be an extension of that response (line # ). No comment at this time

Not applicable for the US Target Market - Look to GDSN guidance on how this is handled in other industry sectors when a US manufacturer exports to the EU as a target market These or related conditions have already been addressed in other GDSN industry sectors - we look there for guidance.

Related to regulatory requirements - US example: this product would be regulated under the DEA. Capture of Regulatory information has not been the focus of the US Healthcare supply chain Data Pool initiative. May apply for export or import T/B/D Not required at this time for the US market. In the area of Pharma, the US market has not identified a need at this time for moving large quantities of product detail attributes to the GDSN since they are readily available from other sources. We have not identified a specific coding schema for this purpose. These requirements will depend on regulations and target markets. Not a priority at this time Not required at this time for the US market. In the area of Pharma, the US market has not identified a need at this time for moving large quantities of product detail attributes to the GDSN since they are readily available from other sources. We have not identified a specific coding schema for this purpose. These requirements will depend on regulations and target markets. Not a priority at this time

Not required at this time for the US market. In the area of Pharma, the US market has not identified a need at this time for moving large quantities of product detail attributes to the GDSN since they are readily available from other sources. We have not identified a specific coding schema for this purpose. These requirements will depend on regulations and target markets. Not a priority at this time Not required at this time for the US market. In the area of Pharma, the US market has not identified a need at this time for moving large quantities of product detail attributes to the GDSN since they are readily available from other sources. We have not identified a specific coding schema for this purpose. These requirements will depend on regulations and target markets. Not a priority at this time Not required at this time for the US market. In the area of Pharma, the US market has not identified a need at this time for moving large quantities of product detail attributes to the GDSN since they are readily available from other sources. We have not identified a specific coding schema for this purpose. These requirements will depend on regulations and target markets. Not a priority at this time Not required at this time for the US market. In the area of Pharma, the US market has not identified a need at this time for moving large quantities of product detail attributes to the GDSN since they are readily available from other sources. We have not identified a specific coding schema for this purpose. These requirements will depend on regulations and target markets. Not a priority at this time Not required at this time for the US market. In the area of Pharma, the US market has not identified a need at this time for moving large quantities of product detail attributes to the GDSN since they are readily available from other sources. We have not identified a specific coding schema for this purpose. These requirements will depend on regulations and target markets. Not a priority at this time Not required at this time for the US market. In the area of Pharma, the US market has not identified a need at this time for moving large quantities of product detail attributes to the GDSN since they are readily available from other sources. We have not identified a specific coding schema for this purpose. These requirements will depend on regulations and target markets. Not a priority at this time Not required at this time for the US market. In the area of Pharma, the US market has not identified a need at this time for moving large quantities of product detail attributes to the GDSN since they are readily available from other sources. We have not identified a specific coding schema for this purpose. These requirements will depend on regulations and target markets. Not a priority at this time Not required at this time for the US market. In the area of Pharma, the US market has not identified a need at this time for moving large quantities of product detail attributes to the GDSN since they are readily available from other sources. We have not identified a specific coding schema for this purpose. These requirements will depend on regulations and target markets. Not a priority at this time

Not required at this time for the US market. In the area of Pharma, the US market has not identified a need at this time for moving large quantities of product detail attributes to the GDSN since they are readily available from other sources. We have not identified a specific coding schema for this purpose. These requirements will depend on regulations and target markets. Not a priority at this time Not required at this time for the US market. In the area of Pharma, the US market has not identified a need at this time for moving large quantities of product detail attributes to the GDSN since they are readily available from other sources. We have not identified a specific coding schema for this purpose. These requirements will depend on regulations and target markets. Not a priority at this time Not required at this time for the US market. In the area of Pharma, the US market has not identified a need at this time for moving large quantities of product detail attributes to the GDSN since they are readily available from other sources. We have not identified a specific coding schema for this purpose. These requirements will depend on regulations and target markets. Not a priority at this time Not required at this time for the US market. In the area of Pharma, the US market has not identified a need at this time for moving large quantities of product detail attributes to the GDSN since they are readily available from other sources. We have not identified a specific coding schema for this purpose. These requirements will depend on regulations and target markets. Not a priority at this time GDSN handles this issue in other industry sectors - will follow guidelines GDSN handles this issue in other industry sectors - will follow guidelines.. However it should be noted that we recommend that if a product has had a federal or manufacturer recall, there should be a separate indicator of that associated with the date of recall, possibly the reason and/or a URL explaining the details of the recalled products and instructions. The recall issue may already have been addressed by the GDSN standards for other industry sectors.

GDSN handles this issue in other industry sectors - will follow guidelines

T/B/D

T/B/D

T/B/D T/B/D Not applicable to U.S. Target Market Not applicable to U.S. Target Market

Not applicable to U.S. Target Market Not applicable to U.S. Target Market Not applicable to U.S. Target Market

Not applicable to U.S. Target Market

Not applicable to U.S. Target Market Not applicable to U.S. Target Market Not applicable to U.S. Target Market - see earlier comments on kits

Not applicable to U.S. Target Market - see earlier comments on kits

Not applicable to U.S. Target Market - see earlier comments on kits

Not applicable to U.S. Target Market - see earlier comments on kits


								
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