ISSUE NO 18 May – August 2004

JULY – SEPTEMBER 2005 Issue No. 21

M E D I C I N A L P R O D U C T S

G E N E R A LCONTENTS

GeneralConfidentiality Agreement with FDA 1General Staff Update 1

Human MedicinesLegislation and Guidelines 2New Medicines Legislation 3Variations 3Pharmacovigilance 6Homeopathic Medicines 7

Veterinary MedicinesLegislation and Guidelines 8Legislation Changes 8Mutual Recognition and

Decentralised Procedure 8Product Literature Issues 9Financial Forecast for Veterinary

Department for 2006 10Meetings between clients and

IMB’s Veterinary Department 10Diary Dates 11

ComplianceWholesale Workshop for Suppliers

of Medicinal Products to the Grocery Trade 11

Update on the Transfer of Controlled Drugs Licensing Functions from the Department of Health and Children to the IMB 11

GMP Requirements for Active Substances 11

Updated Good Manufacturing Practice (GMP) Guide 11

Annex 1 – Manufacture of Sterile Medicinal Products 12

Appointments and New Inspectors 12

Statistics 12-18

IMB signs Confidentiality Agreementwith FDA

IRISH MEDICINES BOARD, KEVIN O’MALLEY HOUSE, EARLSFORT CENTRE, EARLSFORT TERRACE, DUBLIN 2 TEL: 01 676 4971 FAX: 01 6767836 EMAIL: FOI@IMB.IE

Shown above is Mr Pat O’Mahony, Chief Executive of the IMB and Dr Murray Lumpkin of the FDA at therecent signing of a confidentiality agreement between the IMB and the FDA. The agreement provides fora formal system of sharing information between the two organisations in a timely manner to furtherenable the common goal of protecting public health. The FDA has similar agreements in place with theEuropean Commission/EMEA and competent authorities in a number of other countries.

STAFF CHANGES

MAURA O’DONOVAN and JAYNE CROWE were appointed Medical Officers in theHuman Medicines Department.

LORCAN ALLEN was appointed Toxicologist in the Human Medicines Department.

CONOR O’DONOVAN was appointed Pharmaceutical Assessor in the Human Med-icines Department.

CLAIRE McCARTHY was appointed Pharmaceutical Assessor in the Human Medi-cines Department.

Legislation and Guidelines

The following EU guidelines havebeen adopted.

CPMP/EWP/021/97 Revision 1Guideline on Clinical Investigationof Medicinal Products for HormoneReplacement Therapy of OestrogenDeficiency Symptoms in Post-menopausal Women (Adopted byCHMP October 2005)

CPMP/EWP/329339/05 Overview ofComments received on Draft Guide-line on Clinical Investigation of Med-icinal Products for HormoneReplacement Therapy of OestrogenDeficiency Symptoms in Post-menopausal Women CPMP/EWP/021/97 rev 1

CPMP/EWP/139391/04 ReflectionPaper on the regulatory guidance forthe use of Health-Related Quality ofLife (HRQL) measures in the evalua-tion of medicinal products (Adoptedby Committee July 2005)

CPMP/EWP/2158/99 Guideline onthe Choice of the Non-InferiorityMargin (Adopted by Committee July2005)

CHMP/EWP/5872/03 corr Guidelineon Data Monitoring Committees(Adopted by Committee July 2005)

CPMP/EWP/519/98 Revision 1 Guideline on Clinical Investigation ofSteroid Contraceptives in Women(Adopted by Committee July 2005)

Topic S8, Step 4 Note for Guidance onImmunotoxicity studies for HumanPharmaceuticals

(EMEA/CHMP/167235/05 - adoptedOctober 2005)

CPMP/QWP/2819/00 (EMEA/CVMP/814/00) Rev. 1 Guideline on Qualityof Herbal Medicinal Products / Tradi-tional Herbal Medicinal Products(CHMP/CVMP adopted July 05)

CPMP/SWP/799/95 Guideline on theNon-Clinical Documentation forMixed Marketing AuthorisationApplications (CPMP adopted 12October 2005)

Update of the ‘Guideline on the Sum-mary of Product Characteristics’(October 2005)

Module 1 - Administrative informa-tion (Part 1: Summary of the dossier -Part 1A Application form - Adminis-trative data) (October 2005)

The following EU Commission guide-lines have been drafted.

Draft update of the ‘Guideline onchanging the classification for thesupply of medicinal products’.

Draft ‘Guidance concerning thepatients’ consultation requirementsfor the package leaflet (Article 59(3)and 61(1) of Directive 2001/83/ECamended by Directive 2001/27/EC’

NEW MEDICINES LEGISLATION

Transitional arrangements

Directives 2004/27/EC and 2004/24/EC are due to be transposed

into Irish law by means of regulationsto be made under the Irish MedicinesBoard Act. As the making of the regu-lations has been delayed, transitionalarrangements have been agreedbetween the Department of Healthand Children and the IMB in relationto the new requirements in the direc-tives for medicinal products forhuman use. The following guidanceis provided to PA holders and appli-cants in order to assist them in mak-ing applications to the IMB. It doesnot include an exhaustive list of theprovisions of the directives: thosewhich place obligations on the com-petent authority will apply, as appro-priate, from 30 October 2005, whilemany others are provided for by cur-rent practice or by the Irish Medi-cines Board Act.

1 Directive 2004/27/EC provisionswhich apply from 30 October2005

1.1Article 10(1) provisions for dataexclusivity and market exclusivity

The new periods of exclusivity

therefore apply to applicationssubmitted from 30 October 2005.

1.2Article 8 and 9 which describesthe content and handling of thedossier

Applicants must also useupdated application forms fornew and renewal applications andstructure the dossier in the updat-ed CTD format as soon as they areprovided by the European Com-mission.

1.3Articles 8.1 and 10 which providefor the legal bases of applications,including the provision relating tothe European reference product

1.4Articles 24(2) and 24(3) relating tothe renewal of marketing authori-sations

1.5Chapter 4 relating to the newdecentralised procedure and therevised mutual-recognition proce-dure.

1.6Articles 46F and 46a whichrequire manufacturing authorisa-tion holders to use only activesubstances which have been man-ufactured in accordance withGMP.

2 Directive 2004/24/EC provisionswhich will take effect on the dateof making of the regulations

2.1Articles 23a, paragraphs 1 and 2which require notification of thedate of marketing and of a cessa-tion in marketing

2.2Articles 24(4) – (6) relating to the‘sunset clause’.

2.3Article 24(4), second paragraph,which provides for public assess-ment reports.

3 Provisions relating to labels andleaflets

The Medicinal Products (Control ofPlacing on the Market) Regulations,as currently drafted, provide for spe-cific transitional arrangements for

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H U M A N M E D I C I N E S

the label and leaflet requirements inTitle V of the directive. These draftregulations state that the require-ments do not apply to any productauthorisation in force on 30 October2005 or any application for a productauthorisation made before that dateuntil 30 October 2010, i.e., a transi-tional period of five years. It isassumed that at least the former datewill be changed to the date of makingof the regulations.

Title V of the directive will there-fore apply to national applicationssubmitted from the date of making ofthe regulations, although applicantsare encouraged to submit labels andleaflets in line with the new require-ments as soon as possible.

As the requirements of Title Vwill apply to mutual-recognition anddecentralised applications from 30October 2005, these applications willhave to include labels and leaflets inline with the revised Title V require-ments when submitted to the IMBfrom 30 October 2005.

4 Periodic Safety Update Reports(PSURs)

PSURs and RenewalsTo aid submission of PSURs on an EU-wide basis, the new PSUR submissionschedule applies from 30 October,therefore renewal applications sub-mitted after October 2005 mayinclude a three-year PSUR, togetherwith bridging data sufficient to meetthe timeline for submission of therenewal application.

For products that are due forrenewal during the next five years,the existing submission cycle applies(i.e., six monthly, yearly for the fol-lowing two years and in support ofthe first renewal application. There-after, the three-year submissionschedule will apply.

The provision for a furtherrenewal on pharmacovigilancegrounds may apply to products withan existing authorisation, for which aPSUR submission schedule will bedetermined on a case by case basis.

Submission of PSURs unrelated to renewal

applicationsThe schedule for submission of PSURsoutside the circumstances of renewalapplications remains unchanged, (asoutlined above), and unless other-

wise specified, thereafter at threeyearly intervals. This submission willbe based on the data lock points(DLP), which should be set accordingto the EU birth date (EBD) or theInternational Birth Date (IBD). EachPSUR should cover the period of timesince the last PSUR and should besubmitted within 60 days of the DLP.

Mutual recognition and decen-tralised procedures

From 30 October, several new aspectsare introduced to the ‘mutual recog-nition’ procedure (MRP). The mainchanges are:• The setting up of a statutorily

based Co-ordination Group whichwill formally replace the MutualRecognition Facilitation Group(MRFG).

• The introduction of a new ‘decen-tralised procedure’ (DCP) for prod-ucts which do not already have amarketing authorisation withinthe EU.

• The introduction of the conceptof ‘potential serious risk’, whichwill be the only basis for disagree-ment between Member Statesregarding the recognition of anexisting authorisation or a recom-mendation to authorise.

• The need for harmonisation oflabels and package leaflets duringthe procedure.

• The introduction of a new referralstage (to the Co-ordinationGroup) prior to arbitration by theCHMP.

• The requirement for an assess-ment report to be made publiclyavailable.

• The inclusion of homeopathicmedicinal products in MRP andDCP procedures, except in arbitra-tion procedures involving referralto CHMP.

Co-ordination GroupsOver the past few months muchwork has been carried out to preparefor these changes. The MRFG andVMRFG have worked with eachother, and with the Heads of Medi-cines Agencies, to prepare for theirtransformation into the co-ordina-tion groups. These groups will becalled CMD(h) and CMD(v) – Co-ordination Group for Mutual Recog-nition and Decentralised Procedures

(human or veterinary). Work on newand updated Best Practice Guides andother documents for the CMDs iswell advanced, and some documentsare already available for consultation.When the CMDs meet for the firsttime in November many of thesedocuments will be ready for adop-tion.

Decentralised ProcedureA basic timeframe for the decen-tralised procedure is given in Direc-tive 2001/83/EC. Within this, a moredetailed timetable common tohuman and veterinary procedureshas been agreed; the flow chart isavailable on the MRFG website andon the IMB website under New Med-icines Legislation. Within thistimetable, the precise standard oper-ating procedures (SOPs) will befinalised by the co-ordination groups.The draft SOP for the decentralisedprocedure for human medicines hasbeen published by the MRFG and isavailable on their website and on theIMB website under New MedicinesLegislation.

Potential Serious Risk GuidelineThe concept of ‘potential serious risk’is underpinned by a CommissionGuideline, as specified in the Direc-tive. A draft of the Guideline is nowunder consideration by the Commis-sion.

Assessment of labellingThe harmonisation of labelling andleaflets during the MRP and DCP willrequire a considerable amount ofadditional work during the proce-dures for all concerned, but it is to behoped that the provision will enableauthorisations to be issued more rap-idly after agreement is reached. Theuse of the QRD templates as recentlypublished (http://www.emea.eu.int/htms/human/qrd/qrdplt/24530905en.pdf ) should assist the assessment.A version of the QRD template, anno-tated specifically for MRP and DCPwill shortly be available.

Referral to CMDThe new 60-day referral procedurewill occur where there is disagree-ment between Member Statesinvolved in a procedure. It will givethe whole CMD the opportunity to

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discuss the issue, and so help to avoidthe need for referral to CHMP.

The management of the CMDreferral procedure has been the sub-ject of discussion by MRFG andVMRFG, with a view to adopting avirtually identical procedure for thehuman and veterinary groups. AStandard Operating Procedure isavailable on the MRFG website.

Publicly available assessment reportA draft Best Practice Guide has beenpublished on the MRFG website. Forevery product, consultation with theapplicant is envisaged before anassessment report is made publiclyavailable. It is expected that this pro-vision will apply for all proceduresreaching Day 90 after 30 October.

Data protection and market exclu-sivity

Directive 2004/83/EC provides for acommon eight-year data protectionperiod in the EU. After eight years,generic applications may be submit-ted and authorised by the competentauthority, although the generic prod-uct cannot be marketed until theexpiry of a further two-years’ of mar-ket exclusivity for the reference prod-uct. This period of market exclusivitycan be extended by a further year if,during the first eight years, the mar-keting authorisation holder obtainsapproval for one or more new thera-peutic indications of significant clini-cal benefit.

A separate one-year of data pro-tection may be obtained for a newtherapeutic indication for a well-established substance and a separateone-year may also be obtained for achange in the classification of supplyof a medicinal product. These periodsof exclusivity relate only to the datasubmitted for the new indication orchange in classification, not to theentire data package for the medicinalproduct.

Guidance on the issues relatingto data protection and market exclu-sivity is included in Chapter 1 of theNotice to Applicants which is due tobe published in November.

Legal basis of applications

The legal basis of applications in Arti-cle 10 of Directive 2001/83/EC hasbeen amended by Directive

2004/27/EC. The new requirementsare explained in Chapter 1 of theNotice to Applicants which is due tobe published in November. A revisedversion of the Module 1.2 applicationform, incorporating the changes inthe legal basis for applications, hasbeen published on the website of theEU Commission and must be used forall new applications from 30 October.

European reference product

Article 10.1, third paragraph, ofDirective 2001/83/EC, as amended byDirective 2004/27/EC, allows a gener-ic application to be made when thereference product is not authorised inthe Member State where the applica-tion is made but is authorised inanother Member State. The condi-tions under which this provision maybe used is explained in Chapter 1 ofthe Notice to Applicants which is tobe published in November.

One aspect of the provisionwhich has been clarified by the EUCommission is that it is only applica-ble in situations where the referenceproduct is not authorised in theMember State where the applicationis made. It cannot be used in situa-tions where the reference product isauthorised in the Member State butthe applicant wishes to refer to a ref-erence product with a different SPCin another Member State.

Labels and leaflets

A number of guidance documentshave recently been published in thearea of patient information as a resultof the changes arising from the newlegislation, Directive 2004/27/EC.

The new label and leaflet require-ment are detailed in Articles 54 to 69of Directive.

Guides which should be consult-ed for further information include:

• Draft guidance concerning consulta-tions with target patient groups forthe package leaflet which has beenpublished by the European Com-mission (August 05), and whichdiscusses user testing. This is avail-able from their website, at http://pharmacos.eudra.org/F2/pharma-cos/docs/Doc2005/08_05/USERTESTING_ 20050817.pdf.

• The European requirements for

Braille Guidance concerning theBraille requirements for labelling andthe package leaflet have been pub-lished (April 05) and are availablealso from the website of the Euro-pean Commission, at http://phar-macos.eudra.org/F2/pharmacos/docs/Doc2005/04_05/Braille_text20050411.pdf

Please note separate guidanceis available in this newsletter onthe implementation of thisrequirement by the IMB.

• The revised QRD human productinformation template with explana-tory notes Version 7 (published07/2005) for centralised productsis a useful guide to aspects of thelayout and detail to be included inproduct information, and is avail-able from http://www.emea.eu.int/htms/human/qrd/qrdplt/AnnotatedTemplate-H.pdf

• A guidance document Draft opera-tional procedure on handling of Con-sultation with target patient groupson the package leaflets (PL) for cen-trally authorised products for humanuse looks at procedural impacts ofthe new legislation on centralisedapplications and is available onthe EMEA website http://www.emea.eu.int/pdfs/human/euleg/27737805en.pdf

• An MRFG/CMD(h) concept paperon Achieving Harmonised PatientInformation for European MR/DCP procedures is available onthe Heads of Agencies website,and discusses the aim of harmon-ising patient information duringthe MR/DCP procedures http://heads.medagencies.org/mrfg/docs/pi/harmon_PI_concept.pdf

• MRFG have also published a use-ful paper Questions and answers onthe implementation of the new legis-lation applicable to productsauthorised through MRP http://heads.medagencies.org/mrfg/new_legislation/docs/QA_new_legisla-tion.pdf

Further informationApplicants are advised to watch fornew information appearing on theMRFG websites (http://heads.medagencies.org) as well as the IMB web-site (www.imb.ie).

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Further information on theimplementation of these provisionsis available in our newsletters avail-able on www.imb.ie on the EMEA’swebsite www.emea.eu.int and EUCommission’s website. http://phar-macos.eudra.org, These sites shouldbe consulted regularly for furtherupdates.

Transitional arrangements formedicinal products will follow theguidance issued by the EMEA for cen-tralised products, and by MRFG formutual recognition products. Nation-al transitional arrangements are indi-cated elsewhere in this newsletter.

Requirements for Braille on labelsand for package leaflet formats suit-able for people with visual impair-ment

In order to ensure improved access toinformation on their medicines forpeople with visual impairment, Arti-cle 56a of Directive 2001/83/EC asamended by Directive 2004/27/EChas been introduced. It requires thatthe name of the medicinal productmust be expressed in Braille formaton the packaging, allowing improveddifferentiation of medicines. It alsorequires that the marketing authori-

sation holder ensures that the pack-age information leaflet is available onrequest in formats which are suitablefor people with visual impairment.The ‘leaflet’ provided should not beabridged in any way.

Further details on these require-ments are available in the followingEU guidance: Guidance concerning theBraille requirements for labelling and thepackage leaflet (Article 56a of Directive2001/83/EC as amended), available onthe website of the European Commis-sion at http://pharmacos.eudra.org/F2/pharmacos/docs/Doc2005/04_05/Braille_text20050411.pdf

IMB RequirementsThe following approach is beingtaken by the IMB to ensure compli-ance with this requirement:

A ‘declaration of compliance’ (seebelow for format) must be providedby the applicant for all new applica-tions, at renewal and for variations toupdate patient information in linewith the provisions of Article 56a ofthe new legislation. The relevant sec-tions 1a or 1b, and 2 must be com-pleted and the declaration must besigned and dated by the applicant’sauthorised representative. The Decla-ration will remain applicable to theproduct unless substituted with arevised declaration.

The Market Compliance Sectionof the IMB Compliance Departmentwill check compliance of thelabelling and the other provisions ofArticle 56a. As part of this work, theMarket Compliance Section willobtain samples of medicinal prod-ucts from the marketplace for check-ing, and will also performinspections, as necessary, in order tomonitor compliance with the provi-sions of Article 56a and with thedeclaration provided over the shelflife of the product.

The Braille requirement appliesto all products authorised after thedate of making of the relevant Irishregulation. It does not apply immedi-ately to products authorised beforethat date, however companies areencouraged to apply the provisions toall medicinal products as soon as pos-sible, and at the latest by 30 October2010, at renewal or by way of varia-tion.

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Format of Braille declaration

Receipts and Validation SectionIrish Medicines BoardKevin O’Malley House Earlsfort CentreEarlsfort Terrace Dublin 2

Marketing authorisation holder’sdeclaration of compliance withArticle 56a of Directive2001/83/EC as amended

Section 1a or 1b, and Section 2 must becompleted- tick box if applicable

Section 1aI <insert name>, being the personresponsible for communicationon behalf of <insert applicantcompany name>, hereby declarethat <insert product name and PAnumber> is in compliance with

Article 56a of Directive2001/83/EC as amended byDirective 2004/27/ EC, as inter-preted by in the European Com-mission guidance 'Guidanceconcerning the Braille require-ments for labelling and thepackage leaflet (Article 56a ofDirective 2001/83/EC as amend-ed)’.

The following text appears in Brailleon the labelling <add here in non-Braille text, the text which appears inBraille>:

I furthermore declare:

• that the text which appears inBraille is easily readable, clearlycomprehensible and does notadversely affect the legibility ofthe non-Braille labelling text,and

• that the Braille used is in a for-

mat suitable for Irish patients.

Section 1bI hereby declare that no Braille isrequired on the labelling as perEuropean Commission guidance‘Guidance concerning theBraille requirements forlabelling and the package leaflet(Article 56a of Directive2001/83/EC as amended)’because the product is intendedfor administration by healthcareprofessionals only.

Section 2I hereby declare that the packageinformation leaflet is availablein formats suitable for the blindand partially-sighted in accor-dance with Article 56a of Direc-tive 2001/83/EC as amended byDirective 2004/27/EC.

<Signature, date and position>

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Marketing of medicinal productsand withdrawals

The IMB has recently published adraft Guide to Marketing Status Notifi-cations and the Sunset Clause for Med-icinal Products for Human Use and adraft form, Notifications of MarketingStatus for Medicinal Products forHuman Use. The form must be usedto notify the IMB when a medicinalproduct is marketed and/or whenmarketing ceases. This applies tomedicinal products with productauthorisations and to homeopathicproducts with certificates of registra-tion but it does not apply to parallelimport products. It will be applica-ble to herbal medicinal productswith a certificate of traditional useregistration. The guide and form areissued as drafts until the MedicinalProducts (Control of Placing on theMarket) Regulations are made bythe Department of Health and Chil-dren.

As a result of this new notifica-tion process, the IMB documentGuidance on Withdrawals of Medici-nal Products for Human Use has beenrevised and is now issued as Guide toWithdrawal of Authorisations or Cer-tificates for Medicinal Products forHuman Use, with a revised form,Notification of Withdrawal of Authori-sations or Certificates for MedicinalProducts for Human Use. This processapplies to medicinal products with aproduct authorisation, parallelimport products, homeopathicproducts with a certificate of regis-tration and will also be applicable toherbal medicinal products with acertificate of traditional use registra-tion.

VARIATIONS

Type IB notifications

From January 2006, in addition toType IA notifications, Type IB

notifications submitted under anincorrect category will also berefused by the IMB. The marketingauthorisation holder will no longerbe given a 30-day period to correctthe error by providing a revisedapplication form and supportingdocumentation for the correct noti-fication category. A new applica-tion must be submitted and a newfee will apply.

Type II variation applications

Any typographical errors identifiedin the marketing authorisationdossier can be corrected only by aType II variation with details clearlystated in the 'present' and 'proposal'section of the variation form. How-ever, such errors may be corrected inconjunction with another Type IIvariation for the same product.

Article 61(3) Notifications of Direc-tive 2001/83/EC

Companies are reminded of theirresponsibility to include all therequired documentation when sub-mitting Article 61(3) notifications.Two copies of the currentlyapproved colour mock-ups withchanges highlighted are required,along with two copies of the pro-posed colour mock-ups signed anddated on each page. Also the appli-cant should ensure that all sectionsof the application form are complet-ed appropriately. Applications can-not be assessed until the requireddocumentation is submitted.

Labels and Package Leaflets

Applicants are reminded that infor-mation of a promotional nature isnot permitted on product labellingor package leaflets. Contact detailspermitted include the telephone orfax number, and the e-mail addressof the marketing authorisation hold-er. References to websites or e-mailslinking to websites, coupons, prod-uct-specific phone lines, mail clubsetc are considered to be promotionalin nature and are not permitted.

PHARMACOVIGILANCE

Provision of Usage Data

In accordance with Article 13 ofRegulation (EC) No 726/2004, Arti-

cle 23 of Directive 2004/27/EC, andthe Notice to Marketing Authorisa-tion Holders (Volume 9 of the RulesGoverning Medical Products in the EU –Pharmacovigilance-Medicinal Productsfor Human and Veterinary Use), com-panies are reminded of the obliga-tion to provide usage data forproducts for which they hold mar-keting authorisations, in a timelymanner on request from the IMB.

For practical purposes, these

data should be presented on anannual basis for the period specifiedas an estimate of the number ofpatients treated, or prescriptions dis-pensed. Where relevant, the datashould be broken down by presenta-tion (e.g., oral, parenteral, topicaletc.).

Electronic Adverse ReactionReporting

Further to previous guidance on thistopic, the IMB is pleased to informcompanies that detailed informationregarding electronic reporting ofadverse reactions, originating fromboth clinical trial and post-market-ing environments, is now availablein the Guide to the Electronic Submis-sion of ICSRs and SUSARs Associatedwith Use of Human Medicines. Thisdocument can be found in the Phar-macovigilance section of the websitewww.imb.ie, under ‘ElectronicReporting’.

The guide provides additionalinformation and clarification onmany aspects of electronic reportingof ICSRs and SUSARs, including tech-nical requirements and standards,use of the Eudravigilance Gatewayand EVWeb interface, testing andproduction phases, as well as links toa number of useful documents andwebsites.

Companies are reminded of theirobligation to submit ADR reportselectronically from 20 November2005, in accordance with the consol-idated Directive 2001/83/EC asamended (Directive 2004/27/EC)and Regulation (EC) 726/2004.

Further information on electron-ic reporting is available in Part III –EU Electronic Exchange of Pharma-covigilance Information - Volume 9 ofthe Rules Governing Medical Products inthe EU – Pharmacovigilance-MedicinalProducts for Human and VeterinaryUse. Volume 9 has been revised inthe context of the amended legisla-tion and it is expected to be releasedfor consultation by the EuropeanCommission shortly.

Electronic Adverse Reaction Report-ing - Compliance with E2B regula-tions - Reminder

In order to allow the IMB to meetcompliance requirements for elec-

tronic reporting, companies whohave not yet completed the testingphase and continue to submit papercopies of adverse reaction reports asof December 2005 are reminded toprovide details of the primary sourcereporter, until paper copies of reportsare no longer required. At a mini-mum the reporter’s profession/occu-pation must be included in theadverse reaction report, eg nurse, GP,dentist etc.

HOMEOPATHIC MEDICINES

Complex products with and with-out indications

The final phase of the SimplifiedRegistration Scheme (SRS) for

homeopathic medicinal productswas launched on 1 October 2005.Applications for the SRS for complexproducts without indications arebeing accepted as of 1 November2005. A notice to this effectappeared in The Irish Times of 30September.

One change was made to thisnotice from that which appeared inthe last issue of the Newsletter, name-ly, that those products with indica-tions will be dealt with under aseparate scheme, to be announced.This change follows on from the pro-

posed addition of Article 9 of theMedicinal Products (Control of Plac-ing on the Market) Regulations. ThisArticle makes provision for theauthorisation of homeopathic medic-inal products (HMP) with mild indi-cations for self-limiting conditions;see websites (www.imb.ie) and(www.dohc.ie).

Guidelines and application formsfor the scheme to facilitate theseHMP will be available in due course.Applications to authorise these prod-ucts will be accepted in the latter partof 2006 following the expiration ofthe final deadline for receipt of appli-cations under the SRS for productscurrently on the Irish market. Newproducts which qualify for the SRScan, however, continue to be submit-ted for registration.

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Legislation and Guidelines

The following European guidelineshave been adopted.

CVMP/743/00 rev 1 Revised Guide-line on Requirements and Controlsapplied to Bovine Serum used in theproduction of Immunological Veteri-nary Medicinal Products (CVMPadopted July 05)

EMEA/CVMP/814/00 (CPMP/QWP/2819/00) Rev. 1 Guideline on Qualityof Herbal Medicinal Products / Tradi-tional Herbal Medicinal ProductsCPMP/CVMP Adopted July 05)

Legislation changes

The Veterinary Department is contin-uing preparations in advance of theimplementation of the AnimalRemedies Regulations 2005.Amongst the considerable number ofchanges which will affect the autho-risation of veterinary medicinal prod-ucts and veterinary homeopathicmedicinal products are those whichaffect transparency and maintenanceof the supply of medicines on thenational market. The IMB has alreadyprepared a draft template for publica-tion of assessment reports and has

published the draft on the IMB web-site for comments from interestedparties. The IMB has also publisheddraft guidelines and forms on thenotification of marketing and ofceasing to market the products andthe application of the so-called ‘sun-set’ clause. For VPAs issued after 30October 2005, the form must be usedto notify the IMB when the veteri-nary medicinal product is marketedor when marketing ceases. Thisprocess applies to both pharmaceuti-cals and immunologicals as well asregistered veterinary homeopathicremedies. Similarly, the IMB has alsoprepared a guideline and form fornotification of the withdrawal of anauthorised veterinary medicinalproduct or, in the case of a homeo-pathic veterinary medicinal product,a certificate of registration. The formspecifies the reason for withdrawal,

which may be commercial or mayrelate to concerns regarding thequality (including GMP status), safe-ty or efficacy of the product. Formore details of these procedures con-tact Ms. Sinead Barron (sinead.bar-ron@imb.ie).

Mutual recognition and decen-tralised procedures

With the introduction of the newlegislation on 30 October, severalnew aspects are introduced to the‘mutual recognition’ procedure(MRP). The main changes are:

• The setting up of statutorilybased co-ordination groupswhich will formally replace themutual recognition facilitationgroups (VMRFG).

• The introduction of a new‘decentralised procedure’ (DCP)for products which do notalready have a marketing authori-sation within the EU.

• The introduction of the conceptof ‘potential serious risk’, whichwill be the only basis for disagree-ment between member statesregarding the recognition of anexisting authorisation or a recom-mendation to authorise.

V E T E R I N A R Y M E D I C I N E S

• The need for harmonisation oflabels and package leaflets duringthe procedure.

• The introduction of a new referralstage (to the relevant co-ordina-tion group) prior to arbitration bythe CVMP.

• The requirement for an assess-ment report to be made publiclyavailable.

• The inclusion of homeopathicmedicinal products in MRP andDCP procedures, except in arbitra-tion procedures involving referralto CVMP.

Coordination GroupsOver the past few months muchwork has been carried out to preparefor these changes. The VMRFG andMRFG have worked with each other,and with the Heads of MedicinesAgencies, to prepare for their trans-formation into the co-ordinationgroups. These groups will be calledCMD(h) and CMD(v) – Co-ordina-tion Group for Mutual Recognitionand Decentralised Procedures(human or veterinary). Work on newand updated Best Practice Guides andother documents for the CMDs iswell advanced, and some documentsare already available for consultation.When the CMDs meet for the firsttime in November many of thesedocuments will be ready for adop-tion.

Decentralised ProcedureA basic timeframe for the decen-tralised procedure is given in theDirectives (2001/82/EC). Withinthis, a more detailed timetable com-mon to human and veterinary proce-dures has been agreed; the flow chartis available on the MRFG website andon the IMB website under New Med-icines Legislation. Within thistimetable, the precise standard oper-ating procedures (SOPs) will befinalised by the Co-ordinationGroup. The SOP for veterinary medi-cines is almost complete at the timeof writing and will be made availableon the IMB website as soon as possi-ble.

Potential Serious Risk GuidelineThe concept of ‘potential serious risk’is underpinned by a CommissionGuideline, as specified in the Direc-tive. A draft of the Guideline is now

under consideration by the Commis-sion.

Assessment of labellingThe harmonisation of labelling/leaflet during the MRP and DCP willrequire a considerable amount ofadditional work during the proce-dures, for all concerned but it is to behoped that the provision will enableauthorisations to be issued more rap-idly after agreement is reached. Theuse of the QRD templates as recentlypublished (http://www.emea.eu.int/htms/vet/qrd/qrdplt/26556805en.pdf) should assist the assessment. A ver-sion of the QRD template, annotatedspecifically for MRP and DCP willshortly be available. A Best PracticeGuide is almost complete.

Referral to CMDsThe new 60 day referral procedurewill occur where there is disagree-ment between member statesinvolved in a procedure. It will givethe whole CMD the opportunity todiscuss the issue/s, and so help toavoid the need for referral to CVMP.The management of the CMD referralprocedure has been the subject of dis-cussion by VMRFG and MRFG, with aview to adopting a virtually identicalprocedure for the human and veteri-nary groups. A draft Standard Operat-ing Procedure is available forconsultation and will be finalised bythe CMD.

Publicly available assessment reportWork on Best Practice Guides andtemplates is well advanced. Forevery product, consultation with theapplicant is envisaged before anassessment report is made publiclyavailable. It is expected that this pro-vision will apply for all proceduresreaching Day 90 after 30 October.

Further informationApplicants are advised to watch fornew information appearing on theVMRFG and (www.hevra.org) as wellas the IMB website (www.imb.ie).

Product literature issues

With the introduction of the new leg-islation on 30 October, severalchanges are introduced to therequirements for product literaturefor veterinary medicinal products.

All new applications submitted tothe IMB after 30 October 2005 for anational authorisation or throughthe mutual-recognition or decen-tralised procedures must comply withthe new requirements. Applicantsshould ensure that they submit therequired information in line withupdates given on the EU Commis-sion, EMEA and VMRFG websites.

For applications currently in-house, applicants will be asked torevise the product literature in linewith the new requirements beforeauthorisation.

Products which are currentlyauthorised should comply with thenew requirements by 30 October2010 at the latest. The update may bedone at the time of renewal of theproduct authorisation, during thenext variation affecting the productliterature (in both these cases thechanges must be clearly outlined inthe application) or by the submissionof a variation or notification applica-tion, as applicable.

The new legislation includeschanges to:• format and content of the SPC • content of labels • content and format of package

leaflets • package leaflets written in terms

comprehensible for the generalpublic

New SPC format The IMB has updated the nationalSPC template in line with Directive2001/82/EC, as amended by Directive2004/28/EC. We are implementingthe same template as outlined by theEMEA and Quality Review of Docu-ments Group. The new SPC templateand SPC conventions are on the IMBwebsite www.imb.ie for immediateuse, under Veterinary Medicines/Pub-lications/applications forms/SPCtemplate/Veterinary template. ThisSPC template is for pharmaceuticalsand immunologicals products. Forqueries please contact sinead.bar-ron@imb.ie.

Format and Content of the SPCAuthorisations issued after 30 Octo-ber 2005 will be issued in accordancewith the new SPC format. To facili-tate this applicants are requested,where relevant, to submit the SPC inthe new format by e-mail to

PAGE9ISSUE NO 21 July – September 2005

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vetspcs@imb.ie as detailed in IMBNewsletter No 20. The revised SPCguideline has been released for con-sultation and is available on theEMEA website at http://www.emea.eu.int/pdfs/vet/ewp/006505.en.pdf

Products with SPCs and packaging har-

monised between UK and IrelandThe new legislation requires thatchanges be made to the SPC formatand labelling of authorised products.A number of Marketing Authorisa-tion Holders have taken advantage ofthe ‘harmonisation’ initiative set upbetween the IMB and the VeterinaryMedicines Directorate (VMD) in theUK, to achieve a common SPC andpackaging in UK and Ireland. Forproducts which are harmonised inthis way, the IMB and VMD haveagreed that MAHs will be requestedto submit a simultaneous variation toboth authorities, in order to updatethe SPC and labelling in accordancewith the new requirements. In Ire-land this will be by way of a standardnational type II variation, fee code597.

It is hoped that the necessarychanges will be implemented in themarket place within 3 years (i.e. by 30October 2008). MAHs of harmonisedproducts are asked to plan for thesubmission of the variations as neces-sary to achieve this.

Content of labels Changes to the content of labelsinclude the requirement to providespace for the prescribed dose to beindicated. The manufacturer need nolonger be declared on the immediatelabel but remains a requirement forthe package leaflet. QRD templatesare available at http://www.emea.eu.int/htms/vet/qrd/qrdplt/26556805en.pdf. These templates are applicableto centralised authorised productsand annotated versions specificallyfor MRP and DCP will shortly beavailable. As far as possible thesetemplates will also be used for nation-al procedures, as they are a usefulguide to the layout and level of detailthat should be included in the prod-uct literature. Some additionalnational requirements will remainapplicable for MRP, DCP and nation-al applications. These requirementsare in line with national require-ments currently applicable and will

be detailed on the IMB website oncefinalised.

Content and format of package leaflets One significant change to the pack-age leaflet is that the order in whichinformation must be provided isspecified in the legislation. Fordetails of changes to the content andlayout, applicants are again referredto the QRD templates referencedabove.

Package leaflets written in terms compre-

hensible for the general public The new legislation requires that thepackage leaflet be written in termsthat are comprehensible to the gener-al public A draft European guidelineon readability has been agreed byCVMP and will be released for con-sultation shortly. The guideline willbe applicable for new applicationsonly; a policy will be developed forexisting products in the future.

Changes to the method of sale and supplyChanges relating to the prescribing ofveterinary medicines proposed in thedraft revision of the Animal RemediesRegulations in Ireland are not direct-ly linked to the implementation ofthe EU Directive. Any resultantchange to the sale and supply decla-rations on product literature will bedealt with independently of thosechanges arising directly from the EUDirective requirements.

Disposal of Veterinary Medicinal ProductsVPA holders should be aware that thedraft Animal Remedies Regulationsintroduce an obligation on the sup-plier to take back unused or out-of-date veterinary medicinal products.Once the Animal Remedies legisla-tion is finalised and published, theIMB will review the adequacy of thestandard disposal statements cur-rently used and included on thelabeling of veterinary medicinalproducts. Any change to the currentstandard disposal statements will becommunicated to VPA holders.

Financial forecast for VeterinaryDepartment for 2006

In accordance with practice overrecent years, the IMB has been in dis-cussion with stakeholders about the

budget for the provision of its veteri-nary services for 2006. In commonwith applicant companies, the IMBfaces a particular challenge in 2006with the full impact of the new med-icines legislation. The VeterinaryDepartment will also implement theIMB’s new IT system for the manage-ment of applications (NIMBUS), aswell as new transparency measuresregarding its authorisation proce-dures and the continued roll-out ofits quality management procedures.Against a commitment to continue toimprove service levels to customers,the IMB will also have to provideadditional resources for improvedpharmacovigilance measures asrequired by the new legislation.

In order to address the projectedresource needs for 2006, the IMB esti-mates that overall costs will increaseby at least 6%. However, efficienciesgained from new IT and businesspractices mean that the IMB is seek-ing sanction for an overall feeincrease of 4.5% for next year. If youwould like to receive information onthe proposed fee increases for 2006please contact the IMB’s Director ofFinance and Corporate Affairs, Ms.Rita Purcell, by phone or by e-mail atthe following address: foi@imb.ie.

Meetings between clients and IMB’sVeterinary Department

The IMB has a long tradition of meet-ing with stakeholders and on mattersof mutual interest. This facility hasbeen deemed to be very useful toapplicant companies in particular.The protocol for such meetingsincludes sending a written requestsome weeks in advance to the rele-vant persons in the VeterinaryDepartment, agreeing the agenda andnotifying (for security reasons) thepersonnel planning to attend themeeting. Following the meetings,the IMB and the relevant partiesagree the record of the meeting. Overrecent years, the Veterinary Depart-ment has taken responsibility for tak-ing the minutes of such meetings.Following standard procedure, thedraft minutes are forwarded to andagreed between those involved in themeeting. The procedure has provedvaluable to all parties and the IMBwishes to continue to ensure thatrecords of all meetings are document-ed. However, in order to improve our

PAGE10ISSUE NO 21 July – September 2005

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service to stakeholders and to sharethe burden involved, the IMB ispleased to offer visitors the opportu-nity of preparing the minutes foragreement. By this means, it isexpected that stakeholders can moreclearly ensure their objectives are cap-tured in the record of the meeting. Itis also expected that by sharing theworkload, the IMB personnelinvolved can attend to other services,thereby improving the efficiency ofthe Veterinary Department.

The IMB is also pleased to informstakeholders that it is possible to hold‘virtual’ meetings with personnel fromthe IMB’s Veterinary Departmentusing a video link. To avail of thisfacility, it will be necessary to ensure

that the systems operated by stake-holders are functional and compatiblewith those of the IMB. Therefore,applicants wishing to use the facilitywill first need to test it with the IMB’sInformation Technology and ChangeManagement Department (contact:neasa.ryan@imb.ie). Stakeholdersrequesting this facility should clearlystate so when arranging the meetingas the IMB will need to organise themeeting room and necessary hardwarein advance. This initiative serves tounderscore the IMB’s commitment tocustomer service.

Diary date

The Veterinary Department is com-

mitted to continue to improve com-munications with stakeholders. Thedepartment plans to hold an IMB VetInfoDay, tentatively scheduled for acentral Dublin location, on 9 May2006. Final details of the IMB VetInfoDay will be posted on the newssection of the IMB website over thecoming weeks.

PAGE11ISSUE NO 21 July – September 2005

C O M P L I A N C E

WHOLESALE WORKSHOP FORSUPPLIERS OF MEDICINAL

PRODUCTS TO THE GROCERYTRADE 25TH NOVEMBER 2005

The Irish Medicines Board is host-ing a workshop for wholesalers

involved in the supply of medicinalproducts to the grocery trade on 25thNovember, 2005. The workshoptakes place at the Crowne PlazaHotel, Dublin Airport, SantryDemesne, Dublin 9.

The workshop will focus on theprinciples of Good DistributionPractice (GDP) for medicinal prod-ucts. This will include presentationsfrom a number of IMB staff mem-bers, and there will be discussion onspecific issues of interest, includingthe Responsible Person, productrecalls and requirements for a quali-ty system.

While the workshop is beinghosted primarily for the grocerywholesale sector, participants fromthe wider distribution/wholesale sec-tor and from other stakeholdergroups are also welcome.

Registration for the event com-mences at the Crowne Plaza Hotelon November 25th at 12.30pm. Theworkshop takes place from 1.15pmto 5.15pm approximately.

UPDATE ON THE TRANSFER OFCONTROLLED DRUGS L ICENS-

ING FUNCTIONS FROM THEDEPARTMENT OF HEALTH AND

CHILDREN TO THE IMB

The arrangements to enable thetransfer are now at an advanced

stage of development, and it is antic-ipated that legislation to enable theIMB to undertake functions will be inplace by the end of 2005 or early2006.

A formal information meeting onthe transfer of the controlled drugfunctions to the IMB will be hostedfor the relevant sectors to coincidewith the implementation of the legis-lation. Notification of the informa-tion meeting will be provided in duecourse. As part of the process of final-ising arrangements for the transfer,the Controlled Drugs staff have re-located from the Department ofHealth and Children to the Compli-ance Department of the IMB.

GMP REQUIREMENTS FORACTIVE SUBSTANCES

With the impending changes inEU and national legislation, all

manufacturers of medicinal productshave a responsibility to use, in allbatches that they manufacture, only

active substances that are manufac-tured according to Good Manufactur-ing Practice (GMP).

It is expected that manufacturingauthorisation holders gain assurancethat the active substances used aremanufactured in accordance withGMP, by way of auditing active sub-stance suppliers.

As a minimum, finished productmanufacturers will be required todemonstrate:

• A good history of active substancequality;

• Knowledge of GMP compliance,preferably via audit, of the activesubstance manufacturer and anybroker who is involved in repack-aging;

• Only as an interim measure willpaper based audits (e.g. throughquestionnaires) be consideredacceptable, when quality riskmanagement indicates that auditresource should be prioritised toother active substance suppliers.

UPDATED GOODMANUFACTURING PRACTICE

(GMP) GUIDE

The European Commission hasnow published the restructured

Volume IV of the Rules Governing

▼

Medicinal Products in the EuropeanUnion (Good Manufacturing Prac-tices).

Principal changes are as follows:

GMP for Active Substances

With effect from 30th October 2005,Proposed Annex 18 is withdrawn andis replaced by Part II of the GMPGuide. Part II is identical to ProposedAnnex 18, except for a modifiedintroduction extending its scope.

Product Quality Reviews and On-going Stability

Amendments to Chapter 1 - ProductQuality Reviews (PQRs) and Chapter6 - On-going Stability Monitoringhave been finalised and will comeinto effect from 1st January 2006.

A new introduction to the Guide,

reflecting the restructuring activityhas also been published. More infor-mation can be found at: http://phar-macos.eudra.org/F2/pharmacos/new.htmANNEX 1 – MANUFACTURE OF

STERILE MEDICINALPRODUCTS

Aproposed revision to Annex 1 hasbeen published on the Commis-

sion website for a period of consulta-tion which ends on the 30th April2006. Details can also be found at:

http://pharmacos.eudra.org/F2/pharmacos/new.htm:

APPOINTMENTS AND NEWINSPECTORS

Recent appointments within theInspection section include: Mr.

Paul Sexton, appointed to the post ofGMP Manager; Dr. Patrick Costello,appointed to the post of Blood / Tis-sues Manager; Dr. Lorraine Nolan,appointed to the post of ControlledDrugs/GDP Manager; Ms. CelineCreighton, appointed to the post ofGCP / Pharmacovigilance InspectionManager.

Ms. Lisa Anne Byrne and Ms.Deirdre O’Regan have joined the GCP/ Pharmacovigilance Inspections sec-tion, and Mr. Gerard Sheridan hastaken up a position in the GMPInspection section.

Mr. Stan O’Neill, Senior Inspec-tor, will lead on issues relating to Ster-ile GMP and will represent the IMB atthe ad hoc Working Party of GMPInspection Services at the EMEA.

PAGE12ISSUE NO 21 July – September 2005

continued on next page ▼

PA0074/054/001 ONDANSETRONPA0074/054/002 ONDANSETRONPA0074/058/005 Lamot DispersiblePA0074/058/006 Lamot DispersiblePA0074/058/007 Lamot DispersiblePA0074/058/008 Lamot DispersiblePA0074/058/009 Lamot DispersiblePA0077/124/002 FraxiparinePA0077/124/003 FraxiparinePA0077/124/004 FraxiparinePA0077/124/005 FraxiparinePA0077/124/006 FraxiparinePA0126/134/001 Co-AmoxiclavPA0126/149/001 ArthrimelPA0361/017/001 HYOSCINEPA0361/017/002 HYOSCINEPA0476/015/002 AMOCLAVPA0476/026/001 GLIMEPIRIDEPA0476/026/002 GLIMEPIRIDEPA0476/026/003 GLIMEPIRIDEPA0476/026/004 GLIMEPIRIDEPA0540/138/001 LoavelPA0540/138/002 LoavelPA0540/138/003 LoavelPA0540/138/004 LoavelPA0540/138/005 LoavelPA0540/138/006 Loavel

PA0540/138/007 LoavelPA0540/138/008 LoavelPA0711/029/005 TRADOL SRPA0711/029/006 TRADOL SRPA0711/029/007 TRADOL SRPA0736/001/003 Hemohes 6%PA0736/001/004 Hemohes 10%PA0743/014/001 CLENIL MODULITEPA0743/014/002 CLENIL MODULITEPA0743/014/003 CLENIL MODULITEPA0743/014/004 CLENIL MODULITEPA0812/001/002 ZanidipPA0868/005/001 Viartril-S SachetsPA0966/009/001 HyrazPA0966/009/002 HyrazPA0966/009/003 HyrazPA0966/009/004 HyrazPA0966/009/005 Hyraz Titration PackPA1009/007/002 Desmotabs MeltPA1009/007/003 Desmotabs MeltPA1009/007/004 Desmotabs MeltPA1009/017/003 Nordurine MeltPA1009/017/004 Nordurine MeltPA1009/017/005 Nordurine MeltPA1017/005/001 ROCKSPRING RAMIPRILPA1017/005/002 ROCKSPRING RAMIPRILPA1017/005/003 ROCKSPRING RAMIPRIL

Human New Product Authorisations Issued (July–September 2005) PA Number Product Name PA Number Product Name

PA1017/005/004 ROCKSPRING RAMIPRILPA1044/004/001 XYMELPA1044/004/002 XYMELPA1044/004/003 XYMELPA1044/007/001 DOXATANPA1077/109/001 OndansetronPA1077/109/002 OndansetronPA1094/001/001 LORATPA1121/001/001 IBUCAPS IBUPROFENPA1140/002/001 FurosemidePA1140/003/001 Midazolam Injection BPPA1140/003/002 Midazolam Injection BPPA1184/001/001 Pravastatin SodiumPA1184/001/002 Pravastatin SodiumPA1184/001/003 Pravastatin SodiumPPA0465/005/002 SercPPA0465/075/004A LIPITORPPA0465/097/003 NeurontinPPA0465/099/002 Zomig RapimeltPPA0465/104/004 Amaryl

PPA0465/107/001A PARIETPPA0465/107/002A PARIETPPA0465/146/001 NasonexPPA0465/147/001 TevetenPPA0465/147/002 TevetenPPA0465/154/001 MercilonPPA0465/160/001 Salazopyrine ENPPA0465/161/001 HytrinPPA0465/161/002 HytrinPPA0465/161/003 HytrinPPA0465/162/001 Minocin SAPPA0465/163/001 TritacePPA0465/163/002 TritacePPA0465/163/003 TritacePPA0465/163/004 TritacePPA0465/164/001 Dilzem SRPPA0465/164/002 Dilzem SRPPA0465/164/003 Dilzem XLPPA0465/164/004 Dilzem XLPPA0465/166/001 Reminyl

PAGE13ISSUE NO 21 July – September 2005

Human New Product Authorisations Issued (July–September 2005) cont.PA Number Product Name PA Number Product Name

PA0024/005/001 BECOTIDE INHALERPA0024/005/004 Becotide 250PA0024/005/005 Becotide 100PA0016/004/001 COLESTIDPA0823/028/001 SinutabPA0823/027/001 VeganinPA0735/009/001 VisipaquePA0735/009/011 VisipaquePA0823/015/001 BenadrylPA0823/025/002 MucolexPA0894/001/001 Cremalgin BalmPA0437/034/001 PhenytoinPA0540/029/001 Anzemet InjectionPA0540/029/002 AnzemetPA0540/029/003 AnzemetPA0437/020/001 Fentanyl CitratePA0437/020/002 Fentanyl CitratePA0590/001/001 AlcodermPA0590/001/002 Alcoderm LotionPA0590/002/001 Ionax ScrubPA0590/003/001 Ionil T

PA0590/005/001 PsorigelPA1110/007/001 GelcotarPA0970/054/002 Xylocaine AccordionPA0016/013/001 Neo-Medrone AcnePA0544/004/002 Adsorbed Diphtheria and Tetanus Vac-cine BP SyringePA0187/051/005 SalazopyrinPA0022/087/001 HibTITERPA0282/052/001 NifedipinePA0282/052/002 NifedipinePA0516/016/001 Dilzem Once DailyPA1046/004/002 ACICLOVIRPA0437/032/001 AMIKACINPA0437/047/001 EtoposidePA0437/035/001 Morcap SRPA0437/035/002 Morcap SRPA0437/035/003 Morcap SRPA0743/009/002 UriminPA0298/011/001 Co-TrimoxazolePA0298/011/002 Co-Trimoxazole PaediatricPA0585/006/001 Sodium Cromoglycate

Human New Product Authorisations Withdrawn (July–September 2005)PA Number Product Name PA Number Product Name

PA0013/079/005 DiovanPA0038/089/002 TarkaPA0062/041/001 EligardPA0062/041/002 EligardPA0062/042/001 Tamsulosin HydrochloridePA0062/043/001 HystreamPA0111/003/003 RIMACTAZID 150/75PA0111/006/001 RIMCUREPA0111/007/001 RIMSTARPA0126/135/001 SerimelPA0126/135/002 SerimelPA0126/141/001 FungasilPA0126/145/001 CitalopramPA0126/145/002 CitalopramPA0126/145/003 CitalopramPA0126/147/001 ZomelPA0126/147/002 ZomelPA0126/148/001 OsteomelPA0126/148/002 Osteomel Once WeeklyPA0144/047/001 Duac Once Daily GelPA0281/122/001 AmlidPA0281/122/002 AmlidPA0281/123/001 ZotrolePA0281/123/002 ZotrolePA0409/025/001 Disodium PamidronatePA0409/025/002 Disodium PamidronatePA0409/025/003 Disodium PamidronatePA0409/025/004 Disodium PamidronatePA0540/032/005 Batrafen 10mg/g

PA0577/067/001 DepregerPA0577/067/002 DepregerPA0577/070/001 NagerinePA0585/018/001 CitalopramPA0585/018/002 CitalopramPA0585/018/003 CitalopramPA0711/050/005 SivatinPA0805/002/005 LexaproPA0805/003/005 EntactPA0810/001/007 Lipantil SupraPA0923/001/007 BlopressPA0970/030/005 AtacandPA0970/057/004 CrestorPA1045/004/001 OraqixPA1046/014/001 PravastatinPA1046/014/002 PravastatinPA1046/014/003 PravastatinPA1063/019/001 SertraNichePA1063/019/002 SertraNichePA1077/108/001 IPV-InfanrixPA1166/002/001 Plan B (Norlevo)PA1185/004/001 OsteoEzePA1189/002/001 ClarosipPA1189/002/002 ClarosipPA1189/002/003 ClarosipPA1189/003/001 Clarithromycin GrunenthalPA1189/003/002 Clarithromycin GrunenthalPA1189/003/003 Clarithromycin Grunenthal

10850/007/001 VIRBAMEC SUPER SOLUTION FOR INJECTION

10996/188/001 PANACUR PET PASTE

10809/001/001 ENROX ORAL SOLUTION 100 MG/ML10999/098/001 NOROCARP 5% SMALL ANIMAL

SOLUTION FOR INJECTION10999/102/001 NOROCARP 5 %W/V SOLUTION FOR

INJ FOR CATTLE

10999/104/001 NOROCARP LARGE ANIMAL 5% SOLUTION FOR INJECTION

10999/105/001 MACROMECTIN 0.08 % DRENCH

ISSUE NO 21 July – September 2005 PAGE14

Veterinary New Product Authorisations Issued (July–September 2005)VPA Number Product Name VPA Number Product Name

Veterinary New Authorisation Issued (Mutual Recognition) (July–September 2005) VPA Number Product Name VPA Number Product Name

Human New Product Authorisations (Mutual Recognition) (July–September 2005)

PA Number Product Name PA Number Product Name

10016/043/001 ADSPEC STERILE10823/012/001 PHARMAMIN SC10824/001/001 SWITCH10917/002/001 OTODEX SHAMPOO FOR DOGS10960/040/001 MASTEX CONCENTRATED

10965/005/001 HARTZ CONTROL FLEA COLLAR FOR CATS

10965/006/001 HARTZ CONTROL LONG LIFE FLEA COLLAR FOR DOGS

10965/007/001 HARTZ CONTROL LONG-LIFE FLEACOLLAR FOR DOGS10965/008/001 HARTZ CONTROL LONG LIFE FLEA

COLLAR FOR CATS10996/057/001 AMFIPEN LA10996/112/001 PANACUR PELLETS 1.5%

PAGE15ISSUE NO 21 July – September 2005

Veterinary Immunological New Authorisations Issued (Mutual Recognition) (July–September 2005) VPA Number Product Name VPA Number Product Name

Veterinary Product Authorisations Withdrawn (July–September 2005) cont.VPA Number Product Name VPA Number Product Name

10019/075/001 VANGUARD 7

10861/086/001 BRONCHI-SHIELD 10861/087/001 ARTERVAC

10007/041/001 ENTERISOL llEITIS

Veterinary Immunological New Authorisations Issued (July–September 2005) VPA Number Product Name VPA Number Product Name

I R I S H M E D I C I N E S B O A R D

This Bulletin is designed by Ashfield Press Publishing Services for

IRISH MEDICINES BOARD, KEVIN O’MALLEY HOUSE, EARLSFORT CENTRE, EARLSFORT TERRACE, DUBLIN 2tel: +353 1 6764971 fax: +353 1 6767836 email: foi@imb.ie: http://www.imb.ie

Veterinary Product Authorisations Withdrawn (July–September 2005) VPA Number Product Name VPA Number Product Name