imb newsletter-issue no. 26-january-april 2007

ISSUE NO 18 May – August 2004

JANUARY – APRIL 2007 Issue No. 26

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

CONTENTSGeneralUpcoming Events 1Staff Changes 1New Staff Appointments in the

Veterinary Medicines Department 2

Human MedicinesLegislation and Guidelines 2Update on Draft Medicines

Regulations 2Update on Implementation of

Traditional Herbal Medicinal Products Directive (2004/24/EC) 2

Homeopathic Medicines: Legislative Issue Update 2

Reconstitution of Finished Products Prior to Analytical Testing 3

Listing of Manufacturing Sites on Product Authorisations 3

Veterinary MedicinesLegislation and Guidelines 4Change to the National Legislation

Underpinning IMB Authorisation of Veterinary Medicines 4

Classification of Routes of Supply of Veterinary Vaccines 4

Procedure for Co-ordinating the Joint Assessment of Product Literature by the UK and Ireland for Products Authorised throughMutual Recognition and Decentralised Procedures 4

New appointment of the AdvisoryCommittee for Veterinary Medicines 4

Update on Organisational Changes in the Veterinary Medicines Department 4

ComplianceQP discretion / Compliance with the

Marketing Authorisation 5GMP for certain excipients 5Japanese MRA / Record Retention

for Biologicals 5Achieving Compliance with the

Braille and other requirements forlabels and package information leaflets (Ref: Article 56a of Directive No. 2001/83/EC) 5

IMB Market Compliance Activities 6Braille Dot height Issues 6Pharmaceutical Form Issues 7

Statistics 7–12

IRISH MEDICINES BOARD, KEVIN O’MALLEY HOUSE, EARLSFORT CENTRE, EARLSFORT TERRACE, DUBLIN 2 TEL: 01 676 4971 FAX: 01 6767836 EMAIL: [email protected]

G E N E R A L

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UPCOMING EVENTS

Compliance Wholesale DistributionInformation Day

The IMB is pleased to announcethat an information day for

wholesalers and distributors involvedin the distribution of medicinalproducts for human use in Irelandwill take place on the 17 October2007. The event will take place at theCrowne Plaza Hotel, NorthwoodPark, Santry Demesne, Dublin 9.

This event will cover varioustopics related to the licensing andregulation of the distribution, whole-sale and storage of medicinalproducts for human use, includingthe requirements of Good Distribu-tion Practice (GDP).

Presentations will include keyissues of relevance to this sector suchas changes to Irish legislation govern-ing the wholesale distribution ofmedicinal products, feedback fromthe inspection programme in thisarea, regulatory compliance for thewholesaling of controlled drugs andother topical issues.

This information day will be ofinterest to those working in thefollowing sectors of the pharma-related industry: distribution andwholesale; logistics and storageincluding cold-chain distribution;transportation; quality assurance;regulatory affairs and compliance;legal services; training.

Further information including anoverview of the programme for theday, application forms, fee and direc-tions to the venue will be availableon our website (www.imb.ie) shortly.Further information on the eventmay also be obtained throughcontacting the Compliance Depart-ment of the IMB directly.

MEDICINES FOR RAREDISEASES

The IMB will be holding an Infor-mation Day entitled "Medicines

for Rare Diseases: An Opportunity forPatients, Science and Industry" onFriday 9th November 2007 at theCrowne Plaza Hotel, Dublin Airport.

For further information pleasecontact Eimear Murphy [email protected]

VETERINARY MEDICINESINFORMATION DAY 2007

The IMB Veterinary MedicinesInformation Day will be held on

Tuesday 13th November 2007 at theCrowne Plaza Hotel, Dublin Airport.

For further information contactthe Veterinary Medicines departmentof the IMB directly at 6764971.

STAFF CHANGES

Donna McGowan was appointedGCP/Pharmacovigilance Inspector inthe Compliance Department.

Yvonne Looney and Timothy Glynn wereappointed Medical Assessors in theHuman Medicines Department.

Sarah O’Meara was appointedPharmacovigilance Assessor in theHuman Medicines Department.

Leigh-Anne Carney was appointedMarket Surveillance Assessor in theHuman Medicines Department.

Amhairgin Ni Laoi was appointedSecretary to the Board and BuildingsManager.

ISSUE NO 26 January–April 2007

The following new appointmentshave been made in the Veterinary

Medicines Department: Immunological Assessor: Dr. Sarah Walsh;Planning & Licensing Manager: Ms.Elaine Hynes.

Administration: Ms. Gemma Brennan.

Ms. Sinead Barron has left the Veteri-nary Medicines Department to takeup a role with the QMS Section, IMB

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

NEW STAFF APPOINTMENTS IN THE VETERINARY MEDICINESDEPARTMENT

LEGISLATION AND GUIDELINES

CPMP/328/98 Rev. 5 Guideline onthe Acceptability of Invented

names for Medicinal Productsprocessed through the CentralisedProcedure (CHMP released forconsultation January 2007)

UPDATE ON DRAFT IR ISHMEDICINES REGULATIONS

The draft Irish regulations to imple-ment Directives 2004/27/EC and

2004/24/EC have been sent by theIrish government to the EU Commis-sion, under the TRIS procedure ofDirective 98/34/EC. Four draft regula-tions were submitted, relating to thecontrol of advertising, manufacture,wholesale distribution and placingon the market. The texts are availableon the Commission's website athttp://ec.europa.eu/enterprise/tris.They will remain on the Commis-sion's website for examination andcomment by the Commission andother Member States until 6 June2007. The IMB understands that,shortly after this date, the regulationswill be made by the Department ofHealth and Children.

The IMB is currently progressingarrangements on some issues whichwere held pending the making of theregulations. Information on some ofthese issues, including herbal andhomeopathic products, are coveredelsewhere in this newsletter.

UPDATE ON IMPLEMENTATIONOF TRADITIONAL HERBAL

MEDICINAL PRODUCTS DIREC-TIVE (2004/24/EC)

The IMB wishes to provide anupdate on the national implemen-

tation of the European Directive onTraditional Herbal MedicinalProducts (2004/24/EC).

This directive was published inthe Official Journal of the EuropeanUnion (Ref: OJ L 136, 30.04.2004, p.85) on April 30 2004. The Depart-ment of Health and Children hasrecently sent the draft Irish regula-tions required to implement thisDirective in Ireland to the EUCommission for review and approval,as required by European law. Thedraft regulations are available on theCommission's website where theywill remain until 6 June 2007. In theabsence of objections from theCommission, the regulations will besigned into law by the Minister forHealth and Children after this date.

The draft Medicinal Products(Control of Placing on the Market)Regulations 2007 state that, on thecoming into force of the regulations,no medicinal product can be placedon the market without a priormarketing authorisation or certificateof traditional-use registration.However, the regulations provide anexemption from this requirementuntil 30 April 2011 for traditionalherbal medicinal products that wereon the market in the State on thecoming into force of the regulations.

Notwithstanding the above andin order to ensure that relevantproducts hold either a marketing

authorisation or a certificate of tradi-tional-use registration by the 30 April2011, potential applicants should beaware that the new regulations alsoinclude a provision for the IMB toestablish dates by which applicationsfor traditional-use registration mustbe submitted.

The IMB is currently preparingfurther guidance on this and otherparticular sections of the legislation,which will be available on the IMBwebsite www.imb.ie in due course.

Any further queries on the abovecan be sent via e-mail to [email protected]

HOMEOPATHIC MEDICINES:LEGISLATIVE ISSUES UPDATE

The draft Irish regulations currentlywith the EU Commission, as

referred to above, also apply tohomeopathic medicinal products(HMPs). In particular two specificissues are covered.

1) Once the regulations come intoforce, no HMP can be placed onthe market without a priormarketing authorisation orcertificate of registration. HMPsalready on the market on thecoming into force of the regula-tions will have until 30 April2011 to comply with the regula-tions.

Notwithstanding the aboveand in order to ensure thatrelevant products hold a market-ing authorisation or a certificateof registration by the 30 April2011, applicants are advised thatthe new regulations also includea provision for the IMB to estab-

lish dates by which applicationsfor authorisation or registrationmust be submitted.

2) Article 11 of these regulationsmakes provision for a nationalrules scheme for HMPs; furtherguidance on this will be availableon the IMB website www.imb.iein due course.

RECONSTITUTION OFFINISHED PRODUCTS PRIOR

TO ANALYTICAL TESTING

The IMB wishes to remind market-ing authorisation holders that

where a product is presented in acontainer as a powder, granules etc.for reconstitution, the method ofreconstitution used by analyticallaboratories prior to analytical testingof the product should be identical tothat described in the product infor-mation (SPC, label and packageleaflet). This is to ensure that analyti-cal results generated in laboratoriesreflect the actual quality of theproduct on the market and thatpotential issue such as flocculationwill be identified during testing.Additional steps (e.g. sonication),which are not part of the method ofreconstitution in the product infor-mation, should not be employed inthe method of reconstitution used bylaboratories prior to analyticaltesting.

L ISTING OF MANUFACTURINGSITES ON PRODUCT

AUTHORISATIONS

For each Product Authorisation (PA),a complete list of the manufactur-

ers of the active substance(s) andmanufacturers responsible for themanufacture, assembly and batchrelease of the finished product isincluded in Part I, Section 5 of theschedule. The purpose of this articleis to clarify the information to appearin this section of the schedule.

Manufacturer(s) of the ActiveSubstance(s)

As previously advised in the IMBNewsletter no. 19 (Sep-Jan 2005),active substance manufacturers arelisted in Part I, Section 5 of the sched-ule. The details listed for each active

substance manufacturing site dependson the basis on which that site wasregistered as an active substancemanufacturer for the PA in question.

If the active substance manufac-turer was registered on the basis of aCEP issued by the EDQM, the centralpart of the CEP number (e.g. "CEP2000-011" from a CEP numbered "R0-CEP 2000-011-Rev 02") will be listed,along with the name and address ofthe CEP holder. The actual sites ofmanufacture listed on the CEP willnot be listed on the schedule.

In all other cases where the activesubstance manufacturer has not beenregistered on the basis of a CEP, theactual site of manufacture of theactive substance will be listed. Pleasenote that the actual manufacturingsite should be listed, not the officesite of the manufacturer or a site of animporter or broker for the substance.If the office site of a manufacturer orimporter or broker is currently listedon the schedule this should becorrected by way of a Type II varia-tion as outlined in IMB quarterlyNewsletter issue number 21.

If a Product Authorisation sched-ule does not yet list the activesubstance manufacturer(s) this infor-mation will be added at the time ofthe next renewal or in the course ofan appropriate variation application.When submitting the list of theapproved active substance manufac-turer(s) as part of such applications,Marketing Authorisation (MA)holders are requested to clearlyindicate whether active substancemanufacturers have been approvedon the basis of a CEP, and if so to listthe name and address of the CEPholder and the CEP number; this willhelp ensure that PA schedules arecomplete and accurate when issued.Please note that for Type I applica-tions where an applicant can meetthe conditions that allow the changeof active substance manufacturers/sites/CEP holders (Type I No. 14 andType I No. 15 notifications) the appli-

cant is required to list all activesubstance manufacturers on theapplication forms (documentationrequirement 5 and 4 respectively).

Manufacturer(s) responsible formanufacture, assembly and batchrelease of the finished product

All sites responsible for manufacture,assembly and batch release of thefinished product are listed on theschedule under a heading whichspecifies the manufacturing activitiesthat may be performed at each site.Storage, distribution and batchcontrol/testing sites are not listed onPA schedules. For manufacturer(s)responsible for manufacture andassembly of the finished product, thename and address of the actualmanufacturing site is always listed.

Sites of partial manufacture of thefinished product will be listed on theschedule, indicating that the site isresponsible for partial manufacture.On a case-by-case basis the assessormay decide to also list the degree orsteps of partial manufacture forwhich the site is responsible.

For manufacturer(s) responsiblefor batch release either the name andaddress of the actual site or, ifpreferred, the name and address ofthe holder of the manufacturingauthorisation relevant to that sitemay be listed, where these entities aredifferent.

MA holders are also remindedthat an updated package leafletshould be supplied with variationapplications to change the manufac-turer(s) responsible for batch releaseof the finished product. Formarketed products, a colour mock-upof the updated package leaflet shouldbe supplied, signed and dated oneach page. For products which arenot currently marketed, a text versionof the updated package leaflet shouldbe supplied, signed and dated oneach page.

PAGE3ISSUE NO 26 January–April 2007


LEGISLATION AND GUIDELINES

EMEA/CVMP/QWP/339588/2005 Guide-line on Parametric Release (Veterinary)(CVMP adopted October 2006) Theguideline will come into effect on 1January 2007EMEA/CVMP/EWP/8380405 Guidelineon pharmaceutical fixed combinationproducts (Adopted by CVMP 14December 2006)

CHANGE TO THE NATIONALLEGISLATION UNDERPINNING

IMB AUTHORISATION OFVETERINARY MEDICINES

The IMB has been notified by theDepartment of Agriculture and Food

that the Animal Remedies Regulations,2005 (SI no 734 of 2005) have beenreplaced by the European Communi-ties (Animal Remedies) Regulations,2007 SI no 144 of 2007. Authorisationsissued since 10 April 2007 and hence-forth will be issued in accordance withthe new legislation. The revision of thelegislation has no effect on authorisa-tions issued by the IMB previously.

CLASSIFICATION OF ROUTES OFSUPPLY OF VETERINARY VACCINES

Under the aegis of the AdvisoryCommittee for Veterinary

Medicines (ACVM), IMB, a workinggroup of experts, under the chairman-ship of Mr. P.J. O’Connor, has begunits deliberations on the suitability orappropriateness of its current policyin the classification of routes ofsupply of veterinary vaccines. Theobjective of the working group is toreview the currently availablemethods of supply and to prepare aguidance document for the IMB onthe most appropriate criteria to beconsidered when allocating new oraltering existing national supplyroutes of veterinary vaccine products.The working group has called forwritten submissions from interestedparties to be forwarded to the IMBbefore 3 May 2007. Details of therequest are contained in an ‘Avenuesto Explore’ document available on theIMB website: http://www.imb.ie/uploads/documents/5916953_Avenues%20to%20exp lo re%20wi th%20Inte r -ested%20Parties.pdf.

On completion of its work, whichis expected to be before the end ofJuly 2007, the working group willprepare a report for consideration bythe ACVM in relation to this matter.

PROCEDURE FOR CO-ORDINAT-ING THE JOINT ASSESSMENT OFPRODUCT LITERATURE BY THE UK

AND IRELAND FOR PRODUCTSAUTHORISED THROUGH MUTUAL

RECOGNITION AND DECEN-TRALISED PROCEDURES

In September 2006, the IMB and theUK’s Veterinary Medicines Directorate

(VMD) met with representatives fromthe immunological industry to discussthe alignment of Summary of ProductCharacteristics for immunologicalveterinary medicinal products (IVMPs).It became evident from evolvingdiscussions that industry felt therewould be significant benefits in a jointIE/UK assessment of labelling forIVMPs and pharmaceuticals which areavailable in both jurisdictions. TheIMB/VMD saw this as an opportunityto facilitate industry with the addedconsideration that a joint IE/UK assess-ment of labelling would help maintainproducts, in particular IVMPs, on theIrish/UK markets. Hence the ‘Procedurefor co-ordinating the joint assessmentof product literature by the UK and IEfor products authorised throughmutual recognition and decentralisedprocedures’ was drafted and is nowfinalised. This procedure enables theIMB and VMD to co-ordinate assess-ment of proposed joint IE/UK packag-ing following an EU procedure (new,renewal or variation). The implementa-tion date of this procedure is May 12007 and can be availed of by appli-cants for products undergoing newmutual recognition (MR) or decen-tralised procedures (DCP) or forproducts currently undertaking aMRP/DCP procedure which has an‘end of procedure’ date post May 12007. A copy of the proceduraldocument is available on the IMBwebsite. For further details on the jointIE/UK assessment of labelling proce-dure contact Ms. Susan Reid, Immuno-logical Assessor on 00353 1 6343319 orvia e-mail at [email protected].

NEW APPOINTMENT TO THEADVISORY COMMITTEE FOR

VETERINARY MEDICINES

Mr. Raymond Muldoon, MVB, MRCVSwas appointed as a member of

the ACVM with effect from 22 Febru-ary 2007.

VACANCIES IN THE IMB

The IMB is an equal opportunitiesemployer committed to ensuring

the highest scientific standards in aflexible and dynamic working environ-ment. Applications are now invited forthe following posts:

• Haematological Assessor (HumanMedicines) – New role

• Project Officer (Cosmetics) – Newrole

• Pharmaceutical Assessors (HumanMedicines)

• Safety & Efficacy Assessor (Veteri-nary Medicines) – New role

• Pre-Clinical Assessor (VeterinaryMedicines) – New role

• Scientific Officer (Controlled Drugs)• Scientific Officer (Quality Manage-

ment Systems) – New role

Please see the recruitment section ofour website (www.imb.ie) for furtherdetails on the above posts, individualclosing dates and how to apply

UPDATE ON ORGANISATIONALCHANGES IN THE VETERINARY

MEDICINES DEPARTMENT

Following the adoption of the newmanagement structure (see last

Newsletter), the following appoint-ments have been made: VeterinaryAssessment Manager – Dr. DavidMurphy; Quality Assessment Man-ager – Ms. Mary O’Grady; Planningand Licensing Manager – Ms. ElaineHynes. The Veterinary MedicinesDepartment has begun the task ofdeveloping plans to integrate workflows into the new system. It isexpected that the new system will bein place before the end of Q2, 2007and that customer service levels willbe further enhanced over the comingmonths.

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


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QP DISCRETION / COMPLI -ANCE WITH THE MARKETING

AUTHORISATION

The EMEA has recently publishedan agreed format for industry’s

feedback, in particular from QualifiedPersons, on the reflection paper onQP discretion / Compliance with theMarketing Authorisation.

This information can be found atthe url address hosted on the EMEAwebsitehttp://www.emea.europa.eu/Inspections/GMPInspmtg.html

This topic will be discussed withindustry representatives during ameeting with interested parties andthe EMEA’s GMP Inspectors’ WorkingGroup in September 2007.

GMP FOR CERTAINEXCIP IENTS

In preparation for a directive onGMP for certain excipients, the EU

Commission, through DG Enterpriseand Industry, is asking excipientmanufacturers and manufacturers/importers of medicinal products forhuman use (excipient users) tocontribute to a discussion on possibleimpacts of different policy options.With the questionnaires for excipi-ent manufacturers and excipientusers the Commission has alsopublished the draft "Specific Condi-tions of the Application of the Princi-ples and Guidelines of GMP forCertain Excipients" as a possible basisfor a GMP Directive in this area. Forfurther information please refer tohttp://ec.europa.eu/enterprise/pharmaceuticals/index_en.htm

JAPANESE MRA / RECORDRETENTION FOR BIOLOGICALS

The MRA of May 2004 between theEU and Japan currently excludes

biological products. One of thereasons for this is that EU record-keeping requirements for biologicalproducts differ from those applied inJapan. The current EU requirementsare that records are kept for a

minimum of five years or one yearafter batch expiry, whichever is thelonger period. The IMB is seekingcomments from industry on aproposal to include a requirement forEuropean manufacturers to keeprecords relating to the manufactureof biological products for ten years inorder to facilitate extension of theMRA to biological products. Anycomments in relation to thisproposal should be addressed byemail to [email protected] andinclude as subject "Ten year RecordKeeping for Biological Products".Alternatively, manufacturers mayaddress their comments through theindustry representative bodies.

ACHIEVING COMPLIANCEWITH THE BRAILLE AND

OTHER REQUIREMENTS FORLABELS AND PACKAGE

INFORMATION LEAFLETS(REF: ARTICLE 56A OF

DIRECTIVE NO. 2001/83/EC)

The purpose of this article is to providefurther guidance on this topic, in additionto that provided in IMB Newsletter IssuesNo. 21 & 22.

As previously communicated inIssue No. 21 of the IMB Newslet-

ter, European Commission DirectiveNo. 2001/83/EC, as amended byarticle 56a of Directive 2004/27/EC,requires the name of the medicinalproduct, amongst other information,where necessary, to be expressed inBraille on the packaging of medicinalproducts that are intended to beadministered by patients. Inaddition, Article 56a requires that thepackage information leaflet is madeavailable on request in formatssuitable for the blind and partially-sighted.

Article 56a Declaration

The IMB is implementing the aboverequirements by requiring MarketingAuthorisation Holder companies tomake a declaration of compliance

against the requirements of article56a, as elucidated by the EU guidancedocument entitled "Guidanceconcerning the Braille requirementsfor labelling and the package leaflet(article 56a of Directive 2001/83/ECas amended)". The above policy wasalready outlined in IMB’s NewsletterNo. 21. As a result, a declaration ofcompliance must be submitted withall new marketing authorisationapplications. When renewing amarketing authorisation or whensubmitting a variation to updateproduct labelling or a patient infor-mation leaflet, the above declarationmay be made also. The declarationof compliance document is availableon the IMB website athttp://www.imb.ie/uploads/publi-cations/1856107_Braille%20website%20guidance.doc

The IMB declaration of compli-ance document requires that a decla-ration of compliance against therequirements of article 56a be madeby the Marketing AuthorisationHolder or its authorised representa-tive. This is done by completingsections 1a or 1b (as necessary) aswell as section 2 of the form.

In relation to a label on a medici-nal product containing Braille,Section 1a (if applicable) requires theapplicant to declare complianceagainst the requirements of article56a, to indicate in non-Braille textwhat will appear in Braille on theproduct packaging, and also todeclare that:

• the text which appears in Brailleis easily readable, clearly compre-hensible and does not adverselyaffect the legibility of the non-Braille labelling text, and,

• the Braille used is in a formatsuitable for Irish patients.

Section 1b of the form is completedwhen no Braille is required on aproduct labelling in cases where themedicinal product is intended foradministration to healthcare profes-sionals only.

C O M P L I A N C E

Section 2 of the form concernsthe provision of the package infor-mation leaflet in formats suitable forthe blind and partially sighted.

Acceptable Braille Alphabets

In terms of achieving compliancewith the above requirements forIreland, and in an effort toharmonise the IMB requirementswith those of the UK’s Medicines andHealthcare products RegulatoryAgency (MHRA), the IMB, havingconsulted extensively with theNational Council for the Blind ofIreland (NCBI) and with others,recommends that the Braille alpha-bet which is used for labels andleaflets for Irish-authorised medici-nal products should be that stated inthe UK’s Royal National Institute forthe Blind’s (RNIB) Basic Chart ofBraille Signs, and/or that stated in theMHRA’s Chart of Braille Signs used onPharmaceutical Packaging.

The above charts are available onthe MHRA website athttp://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&useSecondary=true&ssDocName=CON2023829&ssTargetNodeId=387

Please note that the Brailleformat stated in the Basic Chart ofBraille Signs of the UK’s RoyalNational Institute for the Blind is therecommended and preferred formatfor Braille for Irish-authorised medic-inal products. This is because itsBraille cells are the most familiar toIrish Braille readers. However, theIMB is also willing accept Braille textwhich is in compliance with theaforementioned MHRA Chart ofBraille Signs used on PharmaceuticalPackaging.

In relation to specification andformatting issues for Braille cells, theIMB, again, having consulted exten-sively with the National Council forthe Blind of Ireland and with others,recommends that the MarburgMedium Braille specification forBraille cells be used on medicinalproduct packaging and labelling forIrish-authorised medicinal products.This is available at http://www.pharmabraille.co.uk/marburg-medium.html).

However, the Braille cell specifi-cations as published by the EuropeanBlind Union are also acceptable to

the IMB. These are available athttp://www.euroblind.org/fichiersGB/ebupharma.htm.

IMB Market Compliance Activities

It should be noted that no assess-ment of Braille text is performed byIMB assessors when a new marketingauthorisation application, a renewalor a variation application to amarketing authorisation is receivedby the IMB. However, the wordingproposed in the declaration providedby the applicant is assessed forcompliance with the requirements ofthe EU Braille guideline. Further-more compliance with the aboverequirements, including compliancewith any article 56a declarationssubmitted to the IMB, is monitoredby the Market Compliance Section ofthe IMB’s Compliance Department.This is carried out via the medicinalproduct sampling and analysisprogramme and the regulatorycompliance inspection programme.

Any issues identified via thiscompliance work are dealt with on acase-by-case basis, and on a risk-basis. This might involve writing tothe Marketing Authorisation Holderwith details of such findings, andwith a request that an investigationbe carried out into the non-compli-ance issue(s) identified and the non-compliance issue(s) corrected in atimely manner. Any additionalaction required to protect patientswill be decided at that time also.While no recalls have been requestedto date by the IMB in relation tonon-compliance issues associatedwith the requirements of article 56a,it is possible that, in cases where therisk is deemed to be unacceptable,market actions such as a productrecall may be required.

In an effort to promote compli-ance with the requirements of article56a, the IMB published informationin IMB Newsletter No. 22 on the mainfindings from Braille-related marketsurveillance work carried out by theIMB in 2006. Those observationswere intended to provide assistanceto companies with respect to thepractical aspects of putting Brailleonto the outer carton of medicinalproducts. In addition, additionaluseful information is provided in theIMB document Product information

requirements under directive 2001/83/EC as amended by Directive2004/27/EC – Further Guidance whichis located on the IMB website athttp://www.imb.ie/uploads/publications/5228491_Braille&UserTesting.pdf

Braille Dot height Issues

In relation to Braille cell dot height,there is currently no official standardin place for this, and the IMB isaware that this is currently an issueof concern for manufacturers andMarketing Authorisation Holders.The IMB recognises that a dot heightof 0.5 mm ± 5%, which has beenproposed by some patient groups, isdifficult to achieve without compro-mising the integrity of the productouter carton or label.

The IMB is also aware that thereare efforts being made via CEN, theEuropean Committee for Standardis-ation, and others to establish astandard for Braille on pharmaceuti-cal packaging, and this is likely toinclude a minimum dot height,which may be less than 0.5 mm ±5%. The German Institute forStandardisation (DIN) has made aproposal concerning the Braillelabelling of pharmaceutical packag-ing, and a CEN working group (No.CEN TC 261 SC5 WG12) is workingto develop a standard Braille formatfor pharmaceutical packaging. Todate, the IMB has provided commenton the early CEN proposal in thisarea, and is awaiting the results ofthis work to be published forcomment.

In the interim, the IMB is notcurrently requiring a dot height of0.5 mm ± 5%, and is taking thefollowing pragmatic approach toBraille cell-dot height issues.

• Without compromising theintegrity of the outer carton orproduct label, a dot height asclose to 0.5 mm ± 5% as possibleshould be achieved.

• The dot height which isachieved should be such that,with this dot height, the Braille iseasily readable by patients inIreland, clearly comprehensibleto patients in Ireland, does notadversely affect the legibility of


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the non-Braille labelling textunderneath, and should bereadable at the end of shelf life ofthe pack in question.

Pharmaceutical Form Issues

Marketing Authorisation Holdersshould be mindful that, in

certain instances, the pharmaceuticalform of the product might berequired in Braille on the productpackaging. This is in order to preventpatient confusion when there is morethan one pharmaceutical form of theproduct on the market. For example,in the case of a non-steroidal anti-inflammatory drugs, the same

product might be available as animmediate release tablet and as aprolonged release tablet, and thevisually-impaired patient needs to beable to determine that they have thecorrect tablet type. In such cases, theIMB may request the pharmaceuticalform of the product to be stated inBraille on the product packaging.


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PA0030/055/001 EX-LAX SENNA PILLSPA0043/042/001 STREPSILS CHESTY COUGHPA0061/018/002 LIVIALPA0179/002/031 0.9% w/v Sodium Chloride Intra

venous InfusionPA0179/004/008 Compound Sodium Lactate Intra

venous Infusion BPPA0240/018/001 SODIUM IODIDEPA0240/018/002 SODIUM IODIDEPA0240/018/003 SODIUM IODIDEPA0240/031/001 THERACAPPA0281/128/001 LamoroPA0281/128/002 LamoroPA0281/128/003 LamoroPA0281/128/004 LamoroPA0281/128/005 LamoroPA0281/129/001 RispalPA0281/129/002 RispalPA0281/129/003 RispalPA0281/129/004 RispalPA0281/129/005 RispalPA0281/129/006 RispalPA0281/129/007 RispalPA0540/150/004 EPILIM CHRONOSPHERE MRPA0540/150/005 EPILIM CHRONOSPHERE MRPA0540/150/006 EPILIM CHRONOSPHERE MRPA0540/150/007 Epilim Chronosphere MRPA0540/150/008 Epilim Chronosphere MRPA0540/150/009 Epilim Chronosphere MRPA0688/006/008 Risperidone Oral SolutionPA0688/007/001 RispatalPA0688/007/002 RispatalPA0688/007/003 RispatalPA0688/007/004 RispatalPA0688/007/005 RispatalPA0688/007/006 Rispatal

PA0688/007/007 RispatalPA0688/007/008 Rispatal 1 mg/ml Oral SolutionPA0688/013/001 CefaclorPA0688/013/002 CefaclorPA0711/132/001 GabinPA0711/132/002 GabinPA0711/132/003 GabinPA0711/132/004 GabinPA0711/132/005 GabinPA0849/002/002 HUMAN ALBUMIN GRIFOLSPA0913/002/006 OXYNORMPA0966/010/001 RUSTINPA0966/010/002 RUSTINPA1077/115/001 SuvalanPA1077/115/002 SuvalanPA1285/017/001 Clarithromycin MedisPA1285/017/002 Clarithromycin MedisPPA0465/038/005 ZoviraxPPA0465/038/006 ZoviraxPPA0465/041/005 Becotide EvohalerPPA0465/064/002 VENTOLIN NebulesPPA0465/092/008 LamictalPPA0465/092/009 LamictalPPA0465/111/002 Singulair PaediatricPPA0465/153/004 SeroquelPPA0465/165/002 ACTONELPPA0465/177/002 Locoid LipocreamPPA0465/188/001 ZoladexPPA0465/188/002 Zoladex LAPPA0465/190/001 RANITIDINEPPA0465/190/002 RANITIDINEPPA0465/191/001 DonaPPA0465/193/001 ZanidipPPA0465/196/001 TOPAMAXPPA0465/196/002 TOPAMAXPPA0465/196/003 TOPAMAX

Human New Product Authorisations Issued (December 2006 – April 2007) PA Number Product Name PA Number Product Name

PA0012/103/001 Fludarabine PhosphatePA0013/096/002 SequidotPA0021/084/001 ProlastinPA0050/153/002 CopegusPA0126/155/001 SulpromelPA0126/155/002 SulpromelPA0126/155/003 SulpromelPA0126/155/004 SulpromelPA0126/160/001 BenprotanPA0126/160/002 BenprotanPA0126/164/001 SumalievePA0126/164/002 SumalievePA0126/166/001 FungasilPA0126/168/001 IstamelPA0126/168/002 IstamelPA0167/125/001 Human AlbuminPA0167/125/002 Human AlbuminPA0372/008/001 FormoterolPA0372/009/001 CefuroximePA0372/009/002 CefuroximePA0566/038/001 GeloplasmaPA0585/024/001 CarboplatinPA0585/025/001 FosalenPA0585/025/002 Fosalen Once WeeklyPA0585/026/001 ByLansPA0585/026/002 ByLansPA0623/008/001 Oxaliplatin MedacPA0711/052/003 ParoxetinePA0711/052/004 Paroxetine

PA0735/010/001 HexvixPA0735/010/002 HexvixPA0736/024/001 EquiHesPA0736/024/002 EquiHesPA0736/024/003 EquiHesPA0736/024/004 EquiHesPA0749/016/001 Tevanate Once weeklyPA0749/019/001 Citalopram TevaPA0749/019/002 Citalopram TevaPA0749/019/003 Citalopram TevaPA0749/031/002 Ciprofloxacin TevaPA0749/031/003 Ciprofloxacin TevaPA0749/031/004 Ciprofloxacin TevaPA0749/033/001 GlimepiridePA0749/033/002 GlimepiridePA0749/033/003 GlimepiridePA0749/033/004 GlimepiridePA0755/003/002 Imodium Plus 2mg/125mg TabletsPA0789/014/001 Ebetaxel 6mg/ml concentrate solution

for infusionPA0798/003/002 diTeBoosterPA0937/005/001 VoriNaPA1009/021/001 PabalPA1067/003/001 Terbinafine Romikim FarmaPA1067/004/001 Terbinafine TerbanoPA1077/107/001 VunexinPA1077/107/002 VunexinPA1077/107/003 VunexinPA1077/107/004 Vunexin

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Human New Product Authorisations Issued (cont) (December 2006 – April 2007) PA Number Product Name PA Number Product Name

PPA0465/196/004 TOPAMAXPPA0465/197/001 FUCIDINPPA1151/014/001 CoversylPPA1151/014/002 CoversylPPA1151/019/001 ReductilPPA1151/019/002 ReductilPPA1151/021/001 Actonel Once a WeekPPA1151/027/001 ImdurPPA1151/028/001 ZoviraxPPA1328/002/002 SeroxatPPA1328/020/002 BetalocPPA1328/023/003 DovonexPPA1328/032/001 ProzacPPA1328/045/002 ACCUPRO

PPA1328/051/001 AULINPPA1328/051/002 AULINPPA1328/055/001 BRICANYL TURBOHALERPPA1328/058/001 Cordarone XPPA1328/063/001 ZybanPPA1328/064/001 CLEXANEPPA1328/065/001 CREONPPA1328/065/002 CREONPPA1328/066/001 DovobetPPA1328/067/001 ZoviraxPPA1328/069/001 ASASANTIN RetardPPA1328/072/001 BettamoussePPA1328/073/001 CAMPRAL ECPPA1328/074/001 CIPROXIN

Human New Product Authorisations (Mutual Recognition) (December 2006 – April 2007) PA Number Product Name PA Number Product Name

PA0002/072/006 CaracePA0012/005/001 Androcur 50 mg TabletsPA0012/051/001 NoctamidPA0012/063/001 FEMODENEPA0012/080/001 MINERVAPA0013/112/001 RESCULAPA0018/003/001 RynacromPA0022/066/001 NORDETTE Coated TabletsPA0022/079/001 TOTELLE CYCLEPA0024/001/003 VENTOLIN ROTACAPPA0024/001/004 Ventolin RotacapPA0038/051/006 Klacid AdultPA0040/018/009 LARGACTILPA0040/031/001 Largactil FortePA0040/062/001 ASCABIOLPA0040/086/001 PENTACARINATPA0046/004/008 FucidinPA0046/059/001 BuramPA0048/027/001 MegacePA0050/128/004 NAPROSYNPA0050/128/005 NAPROSYN 500mg TabletsPA0050/128/007 NAPROSYN ECPA0050/129/001 SYNFLEX Tablets 275 mgPA0073/121/003 Vasofed RetardPA0073/121/004 Vasofed RetardPA0073/121/005 Vasofed RetardPA0073/132/001 Dulax (Lactulose Solution B.P.)PA0074/047/001 CalaminePA0095/006/001 RESPRINPA0095/006/002 RESPRINPA0100/001/001 COLOMYCINPA0100/001/005 COLOMYCINPA0118/003/001 Minims Neomycin Sulphate

PA0118/010/003 Ganda (3+0.5)PA0118/014/002 Minims Homatropine HydrobromidePA0118/017/001 Minims Pilocarpine NitratePA0126/156/001 RamitacePA0126/156/002 RamitacePA0126/156/003 RamitacePA0126/156/004 RamitacePA0126/157/001 TulpinPA0126/157/002 TulpinPA0126/157/003 TulpinPA0126/160/001 BenprotanPA0148/021/001 Blephamide LiquifilmPA0167/005/005 Lignocaine HCL/GlucosePA0167/005/006 Lignocaine HCL/GlucosePA0167/005/007 Lignocaine HCL/GlucosePA0167/010/015 Chlorhexidine AcetatePA0167/010/016 Chlorhexidine AcetatePA0167/089/001 Hetastarch in 0.9% w/v Sodium

Chloride IntravenousPA0167/094/001 Nutracel 400PA0167/094/002 Nutracel 800PA0167/116/002 GAMMABULINPA0167/116/003 GAMMABULIN S/D 10ml Human

Normal ImmunoglobulinPA0172/011/002 PREPARATION HPA0176/034/001 CosalgesicPA0218/008/002 TrisequensPA0218/026/006 INSULATARD INNOLETPA0218/026/007 INSULATARD FLEXPENPA0218/029/006 MIXTARD 30 INNOLETPA0240/009/001 Xenon Gas For InhalationPA0240/011/001 Yttrium [90Y] SilicatePA0240/030/001 Sodium Phosphate [32P]


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PA1130/008/001 RisdonePA1130/008/002 RisdonePA1130/008/003 RisdonePA1130/008/004 Risdone

PA1130/008/005 RisdonePA1130/008/006 RisdonePA1236/001/002 OndansetronPA1336/001/001 Moviprep

PA0590/023/001 EtrivexPA0689/004/001 Mezavant XLPA0711/100/001 Biluta

PA0711/103/001 Doxane XLPA1304/001/001 Tamsulas

Human New Product Authorisations (Mutual Recognition) (cont.) (December 2006 – April 2007) PA Number Product Name PA Number Product Name

Human New Product Authorisations Withdrawn (December 2006 – April 2007) PA Number Product Name PA Number Product Name

Human New Product Authorisations (Decentralised Procedure) (December 2006 – April 2007) PA Number Product Name PA Number Product Name

ISSUE NO 26 January–April 2007 PAGE10

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PA0282/038/001 GlibenclamidePA0282/038/002 GlibenclamidePA0282/047/001 AtenololPA0282/047/002 AtenololPA0282/071/001 Ranitidine BPPA0282/071/002 Ranitidine BPPA0345/002/002 CalcifortePA0408/018/001 Rimasal SalbutamolPA0408/018/002 Rimasal SalbutamolPA0408/030/001 BendrofluazidePA0417/015/001 Actal PastilsPA0436/037/001 Salbutamol CFC - Free InhalerPA0437/039/001 Morphine SulphatePA0437/039/002 Morphine SulphatePA0469/002/001 HydrocalPA0469/016/001 CrystacidePA0469/026/001 SynalarPA0469/026/002 SynalarPA0469/026/003 SynalarPA0469/027/001 Synlar NPA0469/027/002 Synalar NPA0469/028/001 Synalar CPA0469/028/002 Synalar CPA0469/029/001 MetosynPA0469/030/001 Cetavlex AntisepticPA0469/031/001 Hibitane ObstetricPA0469/033/001 SiopelPA0469/034/001 ExeldermPA0484/005/001 Forans Cough MixturePA0484/006/001 Zinc & Castor OilPA0540/032/004 Batrafen Nail LacquerPA0540/056/003 MOLIPAXINPA0540/075/003 SurgamPA0540/079/001 TopisolonPA0540/080/001 TrentalPA0540/108/003 LARGACTILPA0540/108/004 LargactilPA0540/108/005 LargactilPA0540/125/003 SectralPA0544/001/002 Adsorbed Tetanus SyringePA0544/005/001 MENGIVAC (A+C) SINGLE DOSEPA0544/018/002 DIFTAVAX SYRINGEPA0577/069/003 CifloxagerPA0590/014/001 Mistamine modified releasePA0593/008/004 Diclofenac 25PA0593/008/005 Diclofenac 50PA0593/016/001 Flutamid Stada

PA0593/017/001 UROFLOXPA0593/022/001 Oxybutynin StadaPA0610/002/001 DERMIDEXPA0610/014/001 GalpseudPA0654/009/002 NeurobionPA0690/014/001 TechneScan HSAPA0705/013/001 ONKOTRONEPA0711/027/001 AmbrolPA0727/002/001 OtexPA0775/001/001 MOBICPA0775/001/002 MOBICPA0775/001/008 MOBICPA0800/002/002 HAEMATE PPA0800/002/003 HAEMATE PPA0805/003/001 ENTACTPA0805/003/002 ENTACTPA0805/003/003 ENTACTPA0805/003/004 ENTACTPA0805/003/005 EntactPA0812/003/001 Fenticonazole Nitrate VaginalPA0838/005/001 Simvastatin PharmaPA0838/005/002 Simvastatin PharmaPA0838/005/003 Simvastatin PharmaPA0848/002/001 Simvastatin realPA0848/002/002 Simvastatin realPA0848/002/003 Simvastatin realPA0848/002/004 Simvastatin realPA0855/014/001 STREPTASEPA0855/014/002 STREPTASEPA0855/014/003 STREPTASEPA0891/007/001 SITORPA0899/003/003 Stelazine SpansulePA0899/003/004 STELAZINE SPANSULEPA0899/003/005 STELAZINE SPANSULEPA0899/006/001 RheumoxPA0899/006/002 RheumoxPA0943/001/001 PragmatarPA0970/010/001 Inderal InjectionPA0970/010/003 Inderal TabletsPA0970/010/004 Inderal TabletsPA0970/052/001 UnimaxPA0970/052/002 UnimaxPA0979/021/002 LEMSIP CHILDRENS COLD RELIEFPA0979/023/001 Ibuprofen from the makers of DisprinPA1009/011/002 Choragon 5000 u and Choragon

SolventPA1046/010/001 Naproxen

Human New Product Authorisations Withdrawn (cont) (December 2006 – April 2007) PA Number Product Name PA Number Product Name

10799/001/001 Intra-Epicaine 2%w/v Solution for Injection

10801/001/001 Butador 10 mg/ml solution for injection for horses

10859/015/001 Animec 18.7mg/g Oral Paste for Horses

10859/016/001 Vetimec 18.7mg/g Oral Paste for Horses

10879/033/001 Sumex Pour-On Solution 0.5%

10999/110/001 Endectomectin 0.5% w/v Pour-On Solution

10999/113/001 Ultimectin 0.5% w/v Pour-On Solution10999/114/001 Carprogesic 20 mg tablets10999/114/002 Carprogesic 50 mg tablets10999/116/001 Duratyl LA 150mg/ml Suspension for

Injection for P10999/117/001 Combifluke Oral Suspension for Sheep

PA1046/010/002 NaproxenPA1058/001/001 AscalPA1064/001/001 PAMIDRONATE DISODIUMPA1064/001/002 PAMIDRONATE DISODIUMPA1077/008/005 ImigranPA1077/012/001 ZandinePA1077/012/002 ZandinePA1077/013/006 ZANTACPA1077/021/001 CO-AMOXICLAV PAEDIATRICPA1077/021/002 CO-AMOXICLAV JUNIOR

SUSPENSIONPA1077/021/004 CO-AMOXICLAVPA1077/022/002 Co-Amoxiclav Duo 400 mg / 57 mg

per 5 ml Powder foPA1077/022/003 Co-Amoxiclav Duo 500 mg / 125 mg

Film-coated TablePA1077/023/003 ENGERIX B VACCINEPA1077/026/003 HAVRIX MONODOSE VACCINEPA1077/029/001 Infanrix IPV & HibPA1077/031/001 Sterile Saline Solution (0.9%) 1ml

ampoulePA1077/031/002 Sterile Saline Solution (0.9%) 3ml vialPA1077/031/003 Sterile Saline Solution (0.9%) 1ml

syringePA1077/034/001 ParoxetinePA1077/036/002 PriorixPA1077/039/001 Water for InjectionPA1077/039/002 Water for InjectionPA1077/039/003 Water for InjectionPA1077/042/008 Becotide EvohalerPA1077/043/002 FLIXONASE NASULEPA1077/072/002 NimbexPA1077/078/002 RETROVIR

PA1077/084/004 Zovirax I.V.PA1077/084/008 ZoviraxPA1077/091/004 TagametPA1077/091/005 TagametPA1077/098/001 Timentin 1.6PA1077/098/002 Timentin 3.2PA1077/102/001 Ropinirole PaucourtPA1077/102/002 Ropinirole PaucourtPA1077/102/003 Ropinirole PaucourtPA1077/102/004 Ropinirole PaucourtPA1077/102/005 Ropinirole PaucourtPA1077/103/001 Ropinirole Saint-GermainPA1077/103/002 Ropinirole Saint-GermainPA1077/103/003 Ropinirole Saint-GermainPA1077/103/004 Ropinirole Saint-GermainPA1077/103/005 Ropinirole Saint-GermainPA1077/112/001 FRAXIPARINEPA1077/112/002 FraxiparinePA1077/112/003 FraxiparinePA1077/112/004 FraxiparinePA1077/112/005 FraxiparinePA1077/112/006 FraxiparinePA1077/113/001 SalmeterolPA1121/001/001 IBUCAPS IBUPROFENPA1136/001/001 INFUKOLL NPA1136/001/002 INFUKOLL NPA1262/001/003 NocutilPPA0465/002/003B CapotenPPA0465/058/001A ZotonPPA0465/069/001A PremarinPPA0465/069/002A PremarinPPA0465/092/004A LamictalPPA0465/162/001 Minocin SA


Human New Product Authorisations Withdrawn (cont.) (December 2006 – April 2007) PA Number Product Name PA Number Product Name

Veterinary New Product Authorisations Issued (December 2006 – April 2007) VPA Number Product Name VPA Number Product Name

10277/095/001 AquaVac Vibrio Oral10277/096/001 AquaVac Vibrio Immersion & Injection

10277/097/001 AquaVac Furovac10861/093/001 Poulvac iSE

10861/090/001 Duramune Pi + L

10857/047/001 TUR-310857/049/001 Gallivac IBD10857/050/001 Cryomarex Rispens

10861/067/001 Duvaxyn T10861/068/001 Duvaxyn IE Plus10861/069/001 Duvaxyn IE-T Plus

10996/203/001 Nobilis Diluent Oculo Nasal


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: [email protected]: http://www.imb.ie

10825/001/001 Johnsons for fleas Cat Collar10900/012/001 Ark Iodine Spray

10996/044/001 Intercrison 100

10021/051/001 Baycox Bovis 50mg/ml oral suspension

10277/092/001 Florvetol Swine Injectable10277/093/001 Florvetol Cattle Injectable10791/001/001 PHENOXYPEN Water soluble Powder

325mg/g powder for

10792/001/001 Kenostart 3 mg/g Teat dip Solution for cattle (dai

10800/001/001 Cosecure Cattle Bolus

Veterinary New Authorisations Issued (Mutual Recognition) (December 2006 – April 2007)

VPA Number Product Name VPA Number Product Name

Veterinary Product Authorisations Withdrawn (December 2006 – April 2007) VPA Number Product Name VPA Number Product Name

Veterinary Immunological New Authorisations Issued (Mutual Recognition Procedure) (December 2006 – April 2007) VPA Number Product Name VPA Number Product Name

Veterinary Immunological Review Authorisations Issued (December 2006 – April 2007) VPA Number Product Name VPA Number Product Name

Veterinary Immunological New Authorisations Issued (Decentralised Procedure) (December 2006 – April 2007) VPA Number Product Name VPA Number Product Name

Veterinary Immunological New Authorisations Issued (December 2006 – April 2007) VPA Number Product Name VPA Number Product Name

imb newsletter-issue no. 26-january-april 2007

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