GUIDELINE ON THE PACKAGING INFORMATION OF MEDICINAL .
EUROPEAN COMMISSIONDIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETYHealth systems and productsMedicinal products – authorisations, European Medicines AgencyFinal – Revision 14.2NOTICE TO APPLICANTSGUIDELINE ON THE PACKAGINGINFORMATION OF MEDICINAL PRODUCTSFOR HUMAN USE AUTHORISED BY THE UNIONApril 2015This guideline is part of the Notice to Applicants Volume 2C - Medicinal Products forHuman Use - Regulatory Guidelines ofThe Rules governing Medicinal Products in the European UnionRevision 14Update from July 2013 (Directive 2001/83/EC as amended for the last time by Directive2012/26/EU1 and Regulation (EC) No726/2004 as amended for the last time by Regulation(EU) No 1027/20122).Revision 14.1Update from March 2015, which only concerns the Annex.12OJ L 299 of 27.10.2012, p.1.OJ L 316 of 14.11.2012, p. 38Rue de la Loi 200, B-1049 Bruxelles/Wetstraat 200, B-1049 Brussel - Belgium Telex: COMEU B 21877. Telegraphic address: COMEUR Brussels.
Revision 14.2Update from April 2015, to correct PL section in the Annex;2
Legal framework . 3Purpose . 4Section A - Labelling . 51. The text of the labelling.52. Language .53. Additional labelling information required by some Member States .64. Legal status .75. Marketing authorisation number .76. Optional information under Article 62 of the Directive .77. Blind and partially-sighted patients .88. Control of the conformity of the labelling with the Directive .89. Changes to the labelling .9Section B - Package leaflet. 101. The text of the package leaflet.102. Language .103. Optional information under Article 62 of the Directive .11Local representative .115. Blind and partially-sighted patients .126. Control of the conformity of the package leaflet with the Directive.127. Changes to the package leaflet .12Section C - Presentation of the medicinal product. 141.2.Pack sizes.14Pack design (logo, colour, etc. ) .14ANNEX . 153
Legal frameworkRegulation (EC) No 726/2004 of the European Parliament and of the Council laying downCommunity procedures for the authorisation and supervision of medicinal products for humanand veterinary use and establishing a European Medicines Agency3 (hereinafter "theRegulation") lays down a centralised Union procedure for the authorisation of medicinalproducts. This means that there is a single application, a single evaluation and a singleauthorisation allowing direct access to the EU market of a medicinal product bearing a singleset of information.The Regulation provides that an application for the authorisation of a medicinal product forhuman use should specifically and completely include the particulars and documents as referredin particular in Article 8(3)(j) of Directive 2001/83/EC which provides that:"The application [for a marketing authorisation] shall be accompanied by the followingparticulars and documents [ ]: [ ] a mock-up of the outer packaging, containing the detailsprovided for in Article 54, and of the immediate packaging of the medicinal product, containingthe details provided for in Article 55, together with a package leaflet in accordance with Article59".Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 onthe Community code relating to medicinal products for human use4 (hereinafter "the Directive")contains, in Title V 'Labelling and Package Leaflet', provisions on the text of the label andpackage leaflet of medicinal products placed on the EU market.Article 60 of the Directive provides that "Member States may not prohibit or impede theplacing on the market of medicinal products within their territory on grounds connected withlabelling or the package leaflet where these comply with the requirements of this Title".Article 57 of the Directive provides that:"Notwithstanding Article 60, Member States may require the use of certain forms of labelling ofthe medicinal product making it possible to ascertain:— the price of the medicinal product,— the reimbursement conditions of social security organizations,— the legal status for supply to the patient, in accordance with Title VI,— authenticity and identification in accordance with Article 54a(5).For medicinal products authorised under Regulation (EC) No 726/2004, Member States shall,when applying this Article, observe the detailed guidance referred to in Article 65 of thisDirective".Article 65(f) of the Directive provides that:"In consultation with the Member States and the parties concerned, the Commission shall drawup and publish detailed guidance concerning in particular [ ] harmonised provisions for theimplementation of Article 57".34OJ L 136, 30.04.2004, p. 1OJ L 311, 28.11.2001, p. 674
Article 62 of the Directive provides that:"The outer packaging and the package leaflet may include symbols or pictograms designed toclarify certain information mentioned in Articles 54 and 59(1) and other informationcompatible with the summary of the product characteristics which is useful to the patient, to theexclusion of any element of a promotional nature".PurposeThe purpose of this guideline is to describe how the above mentioned provisions of theDirective , apply in the case of a marketing authorisation to be granted by the Commission.In particular, this guideline provide information on the items required by some Member Statesunder Article 57 of the Directive and also on the additional items included in the labellingpursuant to Article 62 of the Directive in order to ensure that these are in conformity with thelegislative provisions and are correctly presented.This shall assist applicants and marketing authorisation holders when drawing up the labellingand package leaflet and preparing the mock-up and specimens of the sales presentation5.Guidelines and other interpretative documents to which references may be included within thisdocument represent the views of their authors.5A mock-up is a copy of the flat artwork design in full colour, presented so that, following cutting and foldingwhere necessary, it provides a replica of both the outer and immediate packaging so that the three dimensionalpresentation of the labelling text is clear. This mock-up is generally referred to as a paper copy and not necessarilyin the material of the sales presentation. A specimen is a sample of the actual printed out outer and immediatepackaging materials and package leaflet (i.e. the sales presentation).5
Section A - Labelling1.The text of the labellingThe Union authorisation of a medicinal product includes the labelling text which is thesame throughout the Union.Article 9, paragraph 4 (d) of the Regulation provides that must be in annex of thefavourable CHMP opinion the draft text of the labelling proposed by the applicant andpresented in accordance with title V of the Directive.Article 54 of the Directive lists the particulars that must appear on the outer packagingof medicinal product or, where there is no outer packaging, on the immediate packaging.Article 61(2) of the Directive provides that the labelling must comply with theprovisions of title V and the particulars listed in the summary of products characteristics.For products authorised by the Union there is a single summary of productcharacteristics agreed at EU level, which forms part of the Commission Decisiongranting the marketing authorisation.However, Article 63(3) of the Directive provides that "Where the medicinal product isnot intended to be delivered directly to the patient, or where there are severe problemsin respect of the availability of the medicinal product, the competent authorities may,subject to measures they consider necessary to safeguard human health, grant anexemption to the obligation that certain particulars should appear on the labelling andin the package leaflet.[ ]" Such requests for exemption regarding particulars must beaddressed to EMA.Furthermore, Member States may require further information, see below point 3 andsome information may be added at the initiative of the applicant/marketing authorisationholder, see below point 6.Article 56 of the Directive provides that the particulars in the labelling shall be easilylegible, clearly comprehensible and indelible. For these aspects, reference is made to theGuideline on the readability of the labelling and package leaflet of medicinal productsfor human use6.Reference is also made to Product information templates and reference documentsprepared by the Quality Review of Documents group and published by the EMA.2.LanguageArticle 63(1), 1st and 2nd sub-paragraph of the Directive provides that"The particulars for labelling listed in Articles 54, 59 and 62 shall appear in anofficial language or official languages of the Member State where the medicinalproduct is placed on the market, as specified, for the purposes of this Directive, by thatMember State.6Revision 1 of 12 January 2009 (ENTR/F/2/SF/jr (2009)D/869).6
The first subparagraph shall not prevent these particulars from being indicated inseveral languages, provided that the same particulars appear in all the languagesused".This means that each Member State where the medicinal product is placed on themarket decide the official language in which the labelling must be presented. Thelabelling must be presented at least in the language or languages of the MemberState(s) where the product is placed on the market. If more than one language is used,then the content of all language versions must be identical and the overall readabilityshould not be adversely affected. . It is recommended to group different text elementsfor each language, where appropriate.However, in case of certain orphan medicinal products, Article 63(1), 3d subparagraph of the Directive provides that "[ ] the particulars listed in Article 54 may,on reasoned request, appear in only one of the official languages of the Community".Such request for exemption should be addressed to EMA.In addition, article 63(3) of the Directive provides that "Where the medicinal productis not intended to be delivered directly to the patient, or where there are severeproblems in respect of the availability of the medicinal product, the competentauthorities may, subject to measures they consider necessary to safeguard humanhealth, grant [ ] a full or partial exemption to the obligation that the labelling andthe package leaflet must be in an official language or official languages of theMember State where the medicinal product is placed on the market, as specified, forthe purposes of this Directive, by that Member State." Such requests for exemptionregarding language should be addressed to concerned national competent authorities.3.Additional labelling information required by some Member StatesArticle 60 of the Directive provides that Member States may not prohibit or impede theplacing on the market of a medicinal product which labelling and package leaflet complywith requirements of Title V of the Directive.However in accordance with article 57, Member States may require the use of certainforms of labelling in order to ascertain: the price of the medicinal product, the reimbursement conditions of social security organizations, the legal status for supply to the patient, in accordance with Title VI of theDirective, authenticity and identification in accordance with Article 54a(5).Annex I of this document lists, by Member State, these national requirements.The information specific to a Member State should be accommodated on the label in asingle boxed area (the so-called ‘blue box’7), to appear on one side of the pack. Each‘blue box’ should only be presented in the official language or languages of theMember State concerned and should state the name of that Member State. The locationof the ‘blue box’ on the package should ideally be the same for all Member States.When one pack is intended for marketing in several Member States,, this box willcontain different information relevant for each Member State. Assembling differentinformation for different Member States in the 'blue box' could be achieved in practice7The "blue box" is a boxed area included in the labelling, with a blue border, aimed at containinginformation specific to each Member State.7
for instance by printing a blank ‘blue box’ on this pack onto which a sticker with theappropriate Member State information can be securely affixed. When in exceptionalcircumstances, several 'blue boxes' are required for the different Member States; theyshould ideally have the same dimensions and appear on the same side of the pack.4. Legal statusIn accordance with Article 9(4)(b) and 10(1) of the Regulation, the CHMP scientificopinion and the Commission decision on the marketing authorisation must respectivelyinclude "details of any conditions or restrictions which should be imposed on the supplyor use of the medicinal product concerned, including the conditions under which temedicinal product may be made available to patients, in accordance with the criteria laiddown in Title VI of Directive 2001/83/EC".Therefore the Commission decision may include one, or more, of the sub-categorieslisted in Article 70 of the Directive as well as other conditions or restrictions on thesupply which are deemed necessary from a public health perspective.Whenever these conditions or restrictions are added to the primary classification assubject or not subject to medical prescription they have to be implemented nationallyusing the available instruments of the legal framework.In addition to appearing in Annex II of the Commission decision granting the marketingauthorisation, the legal supply status may also appear on the labelling text which isincluded in Annex III A of the Commission decision.According to Article 57 of the Directive Member States may require further informationon the legal supply status to be included on the label. This may concern either one, or acombination, of the sub-categories listed in Article 70 of the Directive, or a specificmode of conveying particular information on the legal status. Obviously, thisinformation must be in accordance with the legal supply status in the Commissiondecision granting the marketing authorisation. This implies that a sub-category in thesense of Article 70 of the Directive may not be specified if this is not done in theCommission decision granting the marketing authorisation.Furthermore, in accordance with Article 57 of the Directive, symbols may be used insome Member States to express the legal supply status on the labelling. These areprovided in the Annex of this document.5.Marketing authorisation numberThis is the marketing authorisation number consisting of "EU" followed by a ninedigit number (e.g. "EU/1/96/000/000"). .This number must appear on the package, whilst the (national) identification number, ifany, can only appear (once) in the ‘blue box’ (see above, point 3).6.Optional information under Article 62 of the DirectiveThe labelling may include symbols or pictograms designed to clarify certain informationand other information compatible with the summary of the product characteristics whichis useful to the patient, to the exclusion of any element of a promotional nature. it isrecommended that proposals for such inclusionare discussed with the EMA in advance(e.g at the pre-submission meeting or when submitting mock-ups).8
In some Member States certain expressions, including symbols and pictograms havebecome established for expressing certain items of information. As these particulars areonly known or relevant in some Member States, they should appear in the corresponding‘blue box’ referred to above (see point 4). These are listed in the Annex of thisdocument.Local representativeArticle 1, point 18a of the Directive defines the representative of the marketingauthorisation holder as "the person, commonly known as local representative,designated by the marketing authorisation holder to represent him in the MemberState concerned"."Local Representative" should be taken to mean any natural or legal personestablished in the Union charged, through a contract under private law with themarketing authorisation holder, to represent him in a defined (geographical) area. Thisagreement excludes any transfer of any responsibility imposed on the marketingauthorisation holder by Union law and by national law, regulation and administrativeaction implementing such Union law.Article 54(k) of the Directive provides that must appear on the labelling "the name andaddress of the marketing authorisation holder and, where applicable, the name of therepresentative appointed by the holder to represent him".The designation of a local representative is not obligatory8.The 'local representative' may be indicated in the ‘blue box' on the labelling by name,telephone number and/or e-mail address and logo (optional). Postal address may beincluded if space permits (should not interfere with the legibility of the text which mustmandatory appear on the outer packaging).Local representatives should be able to address queries in the local official EEAlanguage(s) of the country for which they are designated.7.Blind and partially-sighted patientsArticle 56a of the Directive requires the name of the medicinal product (as referred to inArticle 54(a)) to be expressed in Braille format on the packaging.For these aspects, reference is made to the Guideline on the readability of the label andpackage leaflet of medicinal products for human use9.8.Control of the conformity of the labelling with the DirectiveArticle 12(1), 2nd sub-paragraph of the Regulation provides that "Authorisation shall[ ] be refused if [ ] the labelling [ ] proposed by the applicant are not inaccordance with Title V of Directive 2001/83/EC".89ECJ T-179/00 of 3.07.2002.Revision 1 of 12 January 2009 (ENTR/F/2/SF/jr (2009)D/869).9
The labelling of the medicinal product forms part of the authorisation. To this end theCHMP, in accordance with Article 8(3)(j) of the Directive, and Articles 6(1), 7(a) and9(4)(d) of the Regulation, provides the Commission with its opinion w
When one pack is intended for marketing in several Member States,, this box will contain different information relevant for each Member State. Assembling different information for different Member States in the 'blue box' could be achieved in practice 7 The "blue box" is a boxed area included in the labelling, with a blue border, aimed at .
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