1、DRAFT FOR DEVELOPMENT Medical informatics - DD ENV 12610:1998 Medicinal product indentification ICs 11.120.10; 35.240.70 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW DD ENV 12610:1998 National foreword This Draft for Development is the English language version of ENV 12610:
2、1997 This publication is not to be regarded as a British Standard. It is being issued in the Draft for Development series of publications and is of a provisional nature due to the limited duration of the European prestandard. It should be applied on this provisional basis, so that information and ex
3、perience of its practical application may be obtained. Comments arising from the use of this Draft for Development are requested so that UK experience can be reported to the European organization responsible for its conversion into a European Standard. A review of this publication will be initiated
4、2 years after its publication by the European organization so that a decision can be taken on its status at the end of its three-year life. The commencement of the reblew period will be notified by an announcement in Update Standards. According to the replies received by the end of the review period
5、, the responsible BSI Committee will decide whether to support the conversion into a European Standard, to extend the life of the prestandard or to withdraw it. Comments should be sent in writing to the Secretary of BSI Technical Committee IST35, Medical Informatics, at 389 Chiswick High Road, Londo
6、n W4 4AL, giving the document reference and clause number and proposing, where possible, an appropriate revision of the text. A list of organizations represented on this committee can be obtained on request to its secrem. Cross-references The British Standards which implement international or Europe
7、an publications referred to in this document may be found in the BSI Standards Catalogue under the section entitled “International Standards Correspondence Index”, or by using the ”Find” facility of the BSI Standards Ele /EZC 93/39/EEC. Council Directive 93/42/EEC of 14 June 1993 concerning medical
8、devices. Medical Informatics - Categoria structures of systems of concepts - Model for Representation of Semantics STD.BS1 DD ENV L2bLO-ENGL 1978 S lb24bb I17388b1 Tb5 M NOTE: 1. Page 7 ENV 12610:1997 In some countries, e.g. Germany, an active ingredient that is intended to influence the performance
9、 of other active ingredients is called an auxiliary ingredient and identified as such. 3.DEFINITIONS For the purpose of this PreStandard, the following definitions apply : NOTE: 1. 2. 3. 4. 5. An administration device may be an instrument, apparatus, appliance material or other article. An administr
10、ation device can be included in a medicinal product package. An administration device is mostly delivered together with the medicinal product. No definition of administration device is given in the rules governing medicinal products for human use in the European union. The requirements to be fulfill
11、ed in the member states of the European Union by medicinal devices and of implantable medicinal devices are respectively defined in Directive 93/42/EEC and Directive 90/385/EEC, 3.2 batcb;lot: defined amount of material which is uniform in character and quality as evinced by compliance with producti
12、on and quality assurance test requirements and produced during a defined validated process of manufacture EN 3751992 E,EN 376:1992 E NOTES : 1. 2. batch number;lot number: designation in the form of a number identijhg a batch and permitting NOTES: 1. 2. Practice categorial structure: reduced system
13、of concepts to describe the organisation of the semantic categories in a particular system of characteristics CEN/TC25 1 /PT0031 characteristic: abstraction of a property of an object ISO/CD 1087- 1.2: 19961 code value: result of applying a codingscheme to an element within a coded set IS0 238241 Th
14、e material may be either an ingredient, a bulk, intermediate or finished medicinal product or even a medicinal product package. For alternative and compatible definitions we refer to the Glossary of th Guide to Good Manufacturing Practice ancl to Directive 7513 1 WEE, annex , part , E. Control tests
15、 on finished products 3.3 * m * its manufacturing history to be traced EN 3751992 E, modified,EN 376:1992 E, modified batch number is usually made up of alphanumeric characters. For alternative and compatible defmitions refer to the Glossary of the Guide to Good Manufacturing 3.4 3.5 3.6 * The defin
16、itions in this document are to be distinguished from “specifications“ given by several authorities in this highly regulated domain. A specification includes requirements to be fulfilled by the concept or the object in order to apply to the rules defined by the issuing authority. They are frequently
17、but erroneously labeled as definitions. It is not at all the goal of this standard to redefine the requirements to be fulfilled by a concept. The definitions throughout this document are based on the IS0 and CEN rules that applies. Where possible, reference is done to regulatory specifications, more
18、 especially specifications issued by the European Union, Directorate General 111. Page 8 ENV 12610:1997 3.7 3.8 3.9 3.10 3.1 1 3.12 3.13 3.14 coding scheme: collection of rules that maps the elements of one set on to the elements of a second set IS0 238241 synu coding system NOTES: 1 .The elements m
19、ay be characters or character strings. 2.The first set is the coded set and the second is the code element set. 3.A coding scheme, within this standard, should be identified either by its designation or preferably by its HCD (Health Care Coding Scheme Designator), allocated in accordance to ENV 1068
20、: 1993. EXAMPLES: 4.When a coding scheme designation is used, the edition or year of issue, if relevant, should be stated as a part of the designation. CAS Chemical Abstract Service number WHO Drug Directory EXAMPLE: ATC 1992 concept: unit of knowledge constructed through combining characteristics I
21、SOKD 1087-1.2: 19961 concept system: set of concepts structured according to the relations among them definition: statement that describes a concept in order to permit its differentiation from related concepts IS0 10871 designation: symbolic representat ion of a concept IS0 1087-1 applied ISOKD 1087
22、- 1.219961 excipient ingredient;excipient: rnvt.Jwnt that is inert in relation to the intended activity of the medicinal product EXAMPLE: fillers, stabiliser. fltwrinp agents, colouring agents. NOTE: - !. 2. The excipient inSrcJirnt i JI ihr same time a component of a pharmaceutical product. No defi
23、nition of 4.1. ipiw rvL*rtdicnt is given in the mies governing medicinal products for human use in the Ecripein inxw identifier: description ih3t i WJ?!.IC icn! to differentiate objects in a given environment. NOTE: Applied to ihr. thmJin lit of identiQing characteristics that together unambiguously
24、 identimanufacture: complete process of production from the acquisition of all materials through all processing stages and including fmal packaging EN 3751992 E,EN 376:1992 E NOTE: The Glossary of the Guide to Good Manufacturing Practice gives a definition of manufacture: all operations of purchase
25、of materials and products, production, quality control, release, storage, distribution of medicinal products and related controls. STD-BSI DD ENV 12bLO-ENGL 1778 M Lb29bb7 07388b4 774 Page 10 ENV 12610:1997 3.21 3.22 3.23 3.24 3.25 manufacturer : natural or legal person with responsibility for the m
26、anufacfuring of a product Definition from Directive 9 I /356/EEC concerning medical devices, modified NOTE: In order to comply to Directive 92/27/EEC a manufacurer needs to be the holder of the authorisation referred to Article 16 of Directive 75/319/EEC on behalf of whom the qualified person has pe
27、rformed the specific obligations laid down in Article 22 of that Directive. marketing authorisation: legal licence for marketing a medicinalproduct within a given territory Svnonvm:medicinai product authorisation NOTE: I. 2. An authorisation for marketing a trade medicinal product is generally calle
28、d a marketing authorisation. The owner of a marketing authorisation is called a marketing authorisation holder. The pharmacist is legally considered as having an equivalent authorisation regarding officinal and magistral medicinal products. A physician is exceptionally considered as the authorisatio
29、n holder for the magistral medicinal products produced and delivered to his patients. Exceptionally a medicinal product may Rave more than one authorisation holder. (e.g. co-marketing, at least in some countries, e.g. France) on basis of one marketing authorisation. No definition of marketing author
30、isation is given in the rules governing medicinal products for human use in the European union. 3. 4. medicinal product: product intended to be administered to human beings or animals for treating or preventing disease, with the view to making a medical diagnosis or to restore, correct or modify phy
31、siological fnctions.Definition from Directive 65/65 EEC - modified NOTE: I. Definition given by Directive 65/65 EEC: “Any substance or combination of substances presented for treating or preventing disease in human beings and animals. Any substance or combination of substances which may be administe
32、red to human beings or animals with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in human beings or in animals, is likewise considered a medicinal product“ This definition is conceptually correct but technically impair regarding the IS0 and th
33、e CEN rules for formulating definitions. This standard identifies three types of medicinal products: the trade medicinal product, the officinal medicinal product and the magistrsl medicinal product. rnedicinai product identifier: identifier of a medicinalproduct NOTE: “MPI“ is proposed as non-normat
34、ive abbreviation and is used as such in this document 2. medicinal product package, package: delivery unit of a medicinal product in an outer container deprecated term: prcsentation 3 NOTES: I. 2. 3. Medicinal product packages with a fixed amount of medicinal product are the usual dispensing forms i
35、n several European countries. An outer container (3.34) is made of packaging material and may contain also a package insert and an administration device. In most European countries, the inclusion of a package insert is compulsory. No definition of medicinal product package is given in the rules gove
36、rning medicinal products for human use in the European union. This term is considered as deprecated, at least in this meaning. STD-BSI DD ENV LZbLO-ENGL 1998 Page 11 ENV 12610 : 1997 3.26 medicinal product package authorisation, package authorisation : marketing authorisation accorded to a medicinal
37、 product package NOTE: 1. 2. 3. 4. 5. An authorisation for marketing a medicinal product package is part of a marketing authorisation of a medicinal product. it is not a common practice in the European Union to make a distinction between a medicinal product package authorisation and a medicinal prod
38、uct authorisation. The pharmacist is legally considered as having an equivalent authorisation regarding packages of officinal and magistral medicinal products. For each authorisation is one medicinal product package authorisation number is allocated representing the marketing authorisation act. The
39、medicinal product package authorisation number is, at least for magistral medicinal products, frequently at the same time the medicinal product package designation. 3.27 medicinal product package identifier, package identifier: identifier of a medicinal product package NOTE: “MPPI“ or “PI“ are propo
40、sed as non-normative abbreviations and used as such in this document. 3.28 medicinal product package set, package set: set comprising two or more different medicinal product packages marketed under a common medicinal product designation and packaged into a common outer container EXAMPLE: Sotalol tab
41、lets and Aspirin tablets in one combination package. NOTE: For regulatory purposes this set is usually considered as a medicinal product package. 3.29 name: linguistic designation of an individual concept. IS0 1087: 19901 NOTES: 1.When a name is used in the identification of either an ingredient, a
42、medicinal product or a medicinal product package, the name source should be specified. 2.A name used in the identification of a medicinal product can be made up a proprietary or non-proprietary name and one or more name specifiers. Example: Nitroderm TS 10. For more information refer to clause 4.2.1
43、.2 medicinal product name spec#er. name source specifier: designation representing the authoritative source from which the name originates _. m - - E I - _I 3.30 * v, * NOE: I. A name source Fhould be defined as precisely as possible. Edition number and/or year of publication, if relevant, should be
44、 added and considered as a part of the nane source specifier. EXAMPLES: i“ (International Nonproprietary Names of WHO, Geneva) Latin, MN English . MN Modified or MNM ATC, January 1994, (WHO Collab. Centre of Oslo) WHO Record Number (Collab. Centre of Uppsala) German Stoffliste BAN (British Approved
45、Names) USAN (US Adopted Names) European Pharmacopoeia D.0.E (Denominacion Oficial Espanola) CAS (Chemical Abstract Service) NF(Nationaa1 Formularium) to indicate the origin of an officinal formula (Belgium) 2. No definition of name source specifer is given in the rules governing medicinal products f
46、or human use in the European union. STD-BSI DD ENV L2bLO-ENGL 1798 m Lb24bb9 07388bb 547 W Page 12 ENV 12610:1997 3.3 1 3.32 3.33 3.34 3.35 nominal scale: set of values, each having a unique name or symbolENV1614 EXAMPLE: the set of blood groups: A, B, AB, O the list of all ingredients of a pharmace
47、utical product: EXAMPLE: methy Iprednisolone acetate lidocaine hydrochloride pol yeth y lenegl ycol officinal medicinal product: medicinalproduct prepared in a pharmacy or a pharmacy department in accordance with the prescriptions of a pharmacopoeia or a formulary approved by a responsible body. Dep
48、recated term: officinal formula NOTES: 1. An officinal medicinal product does not have a marketing authorisation holder and is intended to be used by different patients. The manufacturer, more especially the pharmacist, is considered to fulfil the role of a marketing authorisation holder. A formula
49、is a pharmaceutical product ratio composition. Directive 65/65/EEC is specifying the requirements to be fulfilled by an “oflcinal medicinal product“ in order to be authorised as a medicinal product. 2. 3. 4. ordinal scale: ordered set of values, each symbolised by words or a combination of numbers and words indicating magnitude.ENV 16 141 EXAMPLE: not detected, weakly positive, positive, strongly positive in the domain of the lab results EXAMPLE in this domain: Augmentin Paediatrk and Augmentin Junior. outer container: container which serve
