IMB Newsletter-Issue No. 33-May-August 2009

PANDEMIC FLU BUSINESS CONTINUITY PLANNING

The Medicinal Products Newsletter is published quarterly by the Irish Medicines Board, Kevin O‟Malley House,

Earlsfort Centre, Earlsfort Terrace, Dublin 2, Ireland. Tel : 01-6764971 Fax: 01- 6767836 E-mail : [email protected]

IRISH MEDICINES BOARD MEDICINAL PRODUCTS NEWSLETTER

Since June, the flu caused by the

Pandemic (H1N1) 2009 virus has

spread to pandemic levels around the

world. The vast majority of cases of

flu have been mild with a small

proportion of severe cases. The virus

continues to spread within Ireland but

as of the end of August, its spread has

stabilised according to reports from

the Health Protection Surveillance

Centre in Ireland. Nevertheless an

increase in influenza-like illness is

expected over the coming months and

businesses are advised to ensure that

appropriate contingency plans are in

place to manage the potential impact

of the pandemic on their operations.

The severity of illness that 2009

H1N1 influenza flu will cause or the

amount of illness that may occur as a

result of seasonal influenza during the

2009–2010 influenza season cannot

be predicted with a high degree of

certainty. Therefore, employers

should plan to be able to respond in a

flexible way to varying levels of

severity and be prepared to refine

their pandemic influenza response

plans if a potentially more serious

outbreak of influenza evolves during

the autumn and winter.

The IMB has developed its own

business continuity plans in order to

ensure that services are maintained as

much as possible throughout the

pandemic period, and that in the

event of a high absence rate, we can

continue to provide critical services

to ensure patient safety.

The IMB expects all authorisation

holders and regulated bodies to

prepare for the pandemic flu by

assessing its likely impact on

operations and ensuring that

contingency plans are in place to

continue to meet all applicable legal

and regulatory requirements .

Particular attention should be paid to

measures to cope with the possible

absence of key staff such as the

qualified person for

pharmacovigilance and the quality

person for batch release. Given the

highly contagious nature of this

particular virus, companies are

advised to plan for the potential

simultaneous absence of the main

qualified persons and their deputies.

Authorisation holders and regulated

bodies are not required to submit

contingency plans to the IMB at this

time, but these may be requested as

the need arises or considered in the

context of inspection.

G E N E R A L

CONTENTS

GENERAL P

Pandemic Flu Business Continuity Planning 1

HUMAN MEDICINES

Variations Regulation (EC) No 1234/2008 2

Public Consultation Process on the “Guide to Electronic 2 Submissions of Applications for Authorisations and

Registrations for Human Medicines”.

Informed Consent Documents for Clinical Trials - 2

Priority Assessment

Guidance for Label/Leaflet Combinations 3

IMB Update on MEDDRA and the MSSO 3

Update on Status of Electronic Submission of Adverse Reaction Reports by Marketing Austhorisation holders

And Clinical Trial Sponsors. 4

VETERINARY MEDICINES Variations Regulation (EC) No 1234/2009 5

Pharmacovigilance Inspections 5

Replacement of Target Animals used in batch Safety

Testing of Veterinary Vaccines 5

Working Group on Classification of Method of Supply of

Veterinary Anti-Parasitic Agents for Companion Animals 5

IMB Veterinary Regulatory Fee Consultations 6

Organogram of Veterinary Medicines Department 6

Staff Changes 5

Resignation from the Advisory Committee for Veterinary Medicines 6

COMPLIANCE

EUDRAGMP 6

Issue of Free Sale Certificates for Medical Devices 6

STATISTICS 7

May–August 2009 Issue No. 33

VARIATIONS REGULATION (EC) NO 1234/ 2008

INFORMED CONSENT DOCUMENTS FOR CLINICAL TRIALS – PRIORITY

ASSESSMENT

T he date of implementation of

the new Variations

Regulation (EC) No 1234/2008 is 1

January 2010. The regulation is

available via the following link: http://eur-lex.europa.eu/LexUriServ/

LexUriServ.do?

uri=OJ:L:2008:334:0007:0024:EN:P

DF. Draft versions of the

Guidelines on all the details of the

various categories of variation

(„classification guideline‟) and

Guidelines on the operation of the

variation procedures („procedural

guideline‟) were published on the

Commission website earlier this

year for public consultation. These

draft guidelines along with

documents from the Commission

summarising the comments

received during the public

consultation are available via the

following link; http://ec.europa.eu/

enterprise/pharmaceuticals/

pharmacos/new_en.htm .

The comments received on the

documents during the public

consultation are currently being

discussed by the Commission and it

is hoped that the final guidelines

will be published on the

Commission website in September

or October of this year.

The IMB appreciates that the new

Variations Regulation and

associated guidelines will have a

significant impact on the regulatory

process for variations and is keen to

ensure that all stakeholders are

fully informed on this topic.

Therefore following publication of

the finalised guidelines by the

Commission, the IMB will also

publish further details on the IMB

website and will ensure

stakeholders are fully informed of

the changes on an ongoing basis.

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

T he IMB requires the submission for

approval of the informed consent

documents (subject information leaflet and

consent form) for clinical trials to be

conducted in Ireland. These documents are

approved within the 60-day timeline,

however, the ethics committee review process

may result in further amendments to the IMB-

approved documents. Where the amendments

are substantial*, they should be submitted to

the IMB as soon as possible for approval. In

order to minimise any delays to the

commencement of the clinical trial, the IMB

commits to ensuring that the amended

informed consent documents receive a priority

assessment.

To facilitate the review process, the cover

letter should indicate that the amendments

have been required by the ethics committee.

The IMB Guide to Clinical Trial Applications,

full details on the application process and

relevant links are available on the website www.imb.ie. *Amendments are regarded as „substantial‟ where

they are likely to have a significant impact on:

the safety or physical or mental integrity of

the subjects; or

the scientific value of the trial; or

the conduct or management of the trial; or

the quality or safety of any investigational

medicinal product used in the trial.

PUBLIC CONSULTATION PROCESS ON

THE ‘GUIDE TO ELECTRONIC

SUBMISSIONS OF APPLICATIONS FOR

AUTHORISATIONS AND

REGISTRATIONS FOR HUMAN

MEDICINES’

T he IMB is undertaking a public consultation

on electronic submissions of applications

for human medicines. Details of the consultation

are given in the consultation information note and

in the „Guide to electronic submissions of

applications for Authorisations and Registrations

for Human Medicines‟. Please submit any

comments that you may have by 30 September

2009 to [email protected]. We look forward to

your contributions to the process.

Page 2 May–August 2009 Issue No. 33

GUIDANCE FOR LABEL/LEAFLET COMBINATIONS

IMB UPDATE ON MEDDRA AND THE MSSO

T he purpose of this article is to

provide guidance to applicants on

the quality requirements for label/leaflet

combinations i.e. a label with the

Package Leaflet contained behind or

underneath it which is attached to the

immediate container. These label and

leaflet systems present greater technical

challenges in ensuring that the

information is presented in a legible

manner that is easily understood by

persons using the medicine.

In line with the European Commission

„Guideline on the Readability of the

Labelling and Package Leaflet of

Medicinal Products for Human Use

revision 1 January 2009‟, the type size

should be as large as possible to aid

readers. For the package leaflet a type

size of at least point 9 as measured in

font „Times New Roman‟, not narrowed

with a space between lines of at least 3

mm, is considered as a minimum.

However for marketing authorisation

applications until 1 February 2011, a type

size of 8 points may be accepted on a

case by case basis assuming legibility is

not compromised. The particulars

appearing on the label of all medicinal

products should be printed in characters

of at least 7 points leaving a space

between lines of at least 3 mm.

The outermost face of the leaflet and the

leaflet face in closest contact with the

packaging i.e. at the end of the leaflet are

both considered to be the immediate

packaging label and the information that

appears on each of these must be

identical and meet all requirements of

Directive 2001/83/EC for labelling of

medicinal products. This is considered

critical because in the event of the outer

label and leaflet becoming detached from

the product, the product must still be

identifiable to the user.

Factors for manufacturers to consider

when using these label/leaflet

combinations include the quality of paper

used (which must be sufficient to

withstand handling during repeated

opening and closing), the quality of

adhesive used to attach the leaflet

securely to the container and the ease

with which the user can access the leaflet.

The point of opening of the leaflet should

be clearly identifiable to the user,

applicants are encouraged to include

helpful phrases such as „open here‟ (or

similar) to facilitate the user. Applicants

should also ensure that the label/leaflet

combination system can be opened and

resealed for the duration of use of the

product bearing in mind the posology of

the product in question.

It is the responsibility of the applicant to

highlight the intention to use this label/

leaflet combination at the time of

submission of the application; in addition

to the provision of mock-ups, a sample of

the actual label and leaflet attached to the

packaging may also be requested during

assessment. In relation to the

incorporation of Braille into label/leaflet

combinations, if it is intended to place the

Braille on the outer most label it must be

ensured that the Braille is readable and

also that the readability of the non-braille

text is not compromised. A Braille

declaration (see IMB website www.imb.ie

„Guide to labels and leaflets of human

medicines‟ AUT-G0034-6 dated 5

August 2009) is also required. Further

information in relation to Braille has been

published in IMB Newsletters number

32, 31, 27, 26, 22, 21. In addition

applicants are required to conduct user

testing of these leaflets as presented for

use i.e. attached to the immediate

packaging.

For further information and guidance

regarding labels and leaflets please see

the IMB website www.imb.ie „Guide to

labels and leaflets of Human Medicines‟

and the European Commission website www.ec.europa.eu/enterprise/

pharmaceuticals/eudralex/vol2_en.htm.

„Guideline on the readability of the

labelling and package leaflet of medicinal

products for human use.‟

T he Medical Dictionary for

Regulatory Activities (MedDRA)

Terminology was developed under the

auspices of ICH and is the standard

international medical terminology for

electronic transmission of adverse reaction

and event reporting. However, the

terminology requires regular updates and

needs to be

appropriately maintained. The

Maintenance and Support Service

Organisation (MSSO) carries out this task

and distributes the terminology, on

license, to users in industry and regulatory

agencies. The use of MedDRA for single

case reports received electronically and for

all adverse drug reaction reporting has

been

mandatory since January 2003. The

Maintenance and Support Services

Organization (MSSO) acts as the source

for the most up-to-date information

regarding MedDRA and its application.

The IMB recommends that MAHs

regularly consult the MSSO website for up

-to-date guidance and information on

MedDRA (http://www.meddramsso.com).


UPDATE ON STATUS OF ELECTRONIC SUBMISSION OF ADVERSE REACTION REPORTS BY MARKETING

AUTHORISATION HOLDERS AND CLINICAL TRIAL SPONSORS

T he IMB continues to monitor

company compliance with electronic

reporting and is pleased to note the

increasing volume of such reports with

98% of all company reports submitted

electronically in July 2009. Up to now,

parallel reports submitted following

testing have been assessed, with paper-

based reporting discontinued on a case by

case basis, as dictated by the quality and

completeness of reports received. In light

of experience gained to date however, the

IMB will no longer require parallel

reporting following completion of

satisfactory testing from 1 October 2009,

unless particular technical issues impact

on the ability to generate complete reports

and the IMB will liaise directly with any

companies affected, in this regard.

As previously highlighted companies are

advised of the need for appropriate quality

control and validation measures to ensure

provision of accurate and complete

reports. Sender information, particularly

the „sender organization‟ field, must be

complete to facilitate receipt and

follow-up of the report by the IMB.

Companies that have not yet contacted the

IMB in regard to registration for electronic

reporting are asked to do so, by contacting

the IMB by email at eudravigilanceimb-

[email protected].

Details of the registration process can be

found in section 4 of the „IMB Guide to

the Electronic Submission of ICSRs and

SUSARs‟, which is available on the IMB

website www.imb.ie. Companies are

reminded that the Medicinal Products

(Control of Placing on the Market)

Regulations, 2007 (S.I. 540 of 2007),

which transposes the EU legislation

nationally, specifies the requirement for

electronic reporting by marketing

authorisation holders and holders of

certificates of traditional-use registration.

The website provides further information

on:

How to subscribe to MedDRA,

Free training programmes, including

on-line training modules and webinars,

The most recent version of MedDRA

and updates for future versions,

How to submit a proposed update for a

future version,

Standardised MedDRA Queries

(SMQs).

Numerous subscriber guidelines and

software tools such as desktop browsers

can also be downloaded through the

MSSO website. As MedDRA is a user-

responsive terminology, subscribers may

submit change requests to the MSSO for

consideration at any time. There are twice

yearly official updates, on 1 September

(for simple changes only) and

1 March (for simple and complex

changes). Subscribers must register a

suitable point of contact with the MSSO,

who will communicate with said person

regarding all new changes and updates.

In order to ensure consistency in reporting

around the time of a version update, the

EMEA released a „Notice to all

Stakeholders Reporting Individual Case

Safety Reports (ICSRs)‟ electronically on

23 August 2007 stating that the new

release version of MedDRA should

become the reporting version on the first

Monday of the second month after it is

released.

To synchronize this event over the three

ICH regions, the MSSO recommends

midnight GMT, Sunday to Monday, for

the switchover. The aim of this approach

is to avoid any disruptions with regard to

the electronic exchange of ICSRs.

This EMEA Notice to Stakeholders is

available on the EudraVigilance website

homepage

(http://eudravigilance.emea.europa.eu)

under the heading „MedDRA‟.

For any further information concerning

MedDRA, please contact the MedDRA

MSSO. Contact details and further

information can be found at http://www.meddramsso.com .


WORKING GROUP ON CLASSIFICATION OF METHOD

OF SUPPLY OF VETERINARY ANTI-PARASITIC

AGENTS FOR COMPANION ANIMALS

T he Board of the IMB at their meeting on 25 June 2009

approved the formation of a working group of the Advisory

Committee for Veterinary Medicines to:

Review the current methods of supply of veterinary anthelmintics and

antiparasitic agents intended for use in companion animals, and

Prepare a guidance document for the IMB on the most appropriate

criteria to allocate such products to the various national supply routes,

taking into consideration the effect of the 2007 legislative changes to

the distribution of veterinary medicines as well as the relevant risks and

benefits associated with use of the products and any practical

constraints.

The Chairperson of the working group is Dr. Iona Pratt, and the

members are Dr. J.G. Beechinor, Dr. Ruaidhrí Breathnach, Mr.

Diarmuid Dooge, Ms. Caroline Garvan and Professor Peter Weedle.

The working group will convene in September 2009 and will invite

submissions from interested parties before framing its report for

consideration by the IMB during 2010.

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

VARIATIONS REGULATION (EC) NO 1234/ 2008

T he date of implementation of the new Variations

regulation (EC) No 1234/2008 is 1 January 2010.

The regulation is available via the following link: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?

uri=OJ:L:2008:334:0007:0024:EN:PDF. Draft versions of

the Guidelines on the details of the various categories of

variation („classification guideline‟) and Guidelines on the

operation of the variation procedures („procedural

guideline‟), were published on the Commission website

earlier this year for public consultation.

These draft guidelines along with documents from the

Commission summarising the comments received during

the public consultation are available via the following

link: http://ec.europa.eu/enterprise/pharmaceuticals/

pharmacos/new_en.htm.

The comments received on the documents during the

public consultation are currently being discussed by the

Commission and it is hoped that the final guidelines will

be published on the Commission website in September or

October of this year.

The IMB appreciates that the new Variations Regulation

and associated guidelines will have a significant impact on

the regulatory process for variations and is keen to ensure

that all stakeholders are fully informed on this topic.

Therefore following publication of the finalised guidelines

by the Commission, the IMB will also publish further

details on the IMB website and will ensure stakeholders

are fully informed of the changes on an ongoing basis.

REPLACEMENT OF TARGET ANIMALS USED IN

BATCH SAFETY TESTING OF VETERINARY

VACCINES

R ecommendations from the Ph. Eur. 01/2008:0062, Vaccines for

Veterinary Use, states that “for an established vaccine the

routine application of the safety test may be waived by the

competent authority in the interest of animal welfare when a

sufficient number of consecutive batches have been produced and

found to comply with the test, thus demonstrating consistency of the

manufacturing process”. Data required for removing the Target

Animal Batch Safety Test (TABST) for Immunological Veterinary

Medicinal Products in the EU can be found in the CVMP position

paper EMEA/CVMP/865/03/Final. The IMB notes that it is the

commercial interests of companies to apply for a variation to have

the safety test waived. However, in the interests of animal welfare,

the IMB wishes to remind applicants of this provision and

encourages companies to follow up with suitable variation

applications. The IMB will consider reducing the fees for such

variation applications for 2010.

PHARMACOVIGILANCE INSPECTIONS

T he first IMB veterinary pharmacovigilance

inspection got underway in late August. A number

of others are planned before year-end. The inspection

team currently comprises personnel from both the

Veterinary Medicines and the Compliance Departments.

The IMB may be assisted by inspectors from overseas for

training and benchmarking purposes.


EUDRAGMP

IMB VETERINARY REGULATORY FEE

CONSULTATIONS

A s is usual around this time of the year, the IMB will

shortly begin a public consultation in respect of its

proposed fees for 2010.

The overall objective of any new fee proposal will be to

ensure that the IMB has adequate resources to meet its

ongoing financial needs, both in respect of protecting public

and animal health as well as customer service.

A particular challenge for 2010 fees will be the impact of

the Variations Regulations as well as the current economic

situation. Details of the fees will shortly be available on the

IMB website (www.imb.ie).

ORGANOGRAM OF VETERINARY MEDICINES

DEPARTMENT

I n response to queries from stakeholders concerning staff

changes and the departmental structure, we wish to point out

that an up-to-date organogram of the veterinary medicines

department is maintained on the IMB‟s website.

The organogram can be found as follows: Click on Home > About

Us > Organisational Structure > Personnel. Scroll down to the

Veterinary Medicines Department, beneath which is a hyperlink to

the latest organisational chart. The chart displays both the post

titles and the names of those filling them.

RESIGNATION FROM THE ADVISORY COMMITTEE

FOR VETERINARY MEDICINES

Mr. Matt Browne MPSI, resigned from the ACVM with effect

from 30 April 2009. The IMB wishes to thank Mr. Browne for

his contribution to its work over the last 3 years.

C O M P L I A N C E

T he EMEA has launched, in July

2009, version 2.0 of its

EudraGMP Community database.

This is the second release after the

version 1.0 launched on 27 April 2007.

EudraGMP v2.0 improves existing

features, delivers new ones and

provides access to the general public

for Manufacturing and Importation

Authorisations (MIAs) and GMP

certificates, with the exception of any

information of a commercially and/or

personally confidential nature.

EudraGMP can be accessed via the

EMEA website using the following

address : http://

eudragmp.emea.europa.eu.

The information in EudraGMP is

divided into two parts. The first part is

comprised of all manufacturing and

importation authorisations issued by

EEA competent authorities in their

respective territories. The second part

includes GMP information, in the form

of GMP certificates or GMP non-

compliance information, for all

authorised sites in the EEA and for

inspected sites in third countries.

It should also be noted that a new

procedure on dealing with serious GMP

non-compliance has been published in

the EU Compilation of Community

Procedures.

In common with a number of other

Member States, details of MIAs and

GMP certificates issued by the IMB are

not yet available via public access on

the EudraGMP database. The IMB is

currently working on a project to

electronically upload the necessary

information to EudraGMP and reformat

all MIAs into the required EU format.

ISSUE OF FREE SALE

CERTIFICATES FOR MEDICAL

DEVICES BY IMB COMPLIANCE

DEPARTMENT

T he issuing of free sale certificates

(FSC) transferred to the Licensing

Section of the Compliance Department on

the 2 June 2009. Applicants are reminded to

submit all applications electronically in

Word 2000 format to [email protected].

Applicants are also reminded that product

codes submitted on the application should

exactly match product codes held on the

Medical Devices database relevant to the

company, as inaccuracies, poor formatting or

omission of information could result in

delays to the issuing of the certificates. New

or updated product codes must be supported

by relevant hard copy documentation

submitted to the Compliance Department.

STAFF CHANGES

Mr. James McKenna, Veterinary Assessor, left the Veteri-

nary Medicines Department on 31 August 2009. We wish

James every success in the future.


HUMAN PRODUCT NEW NATIONAL AUTHORISATIONS ISSUED MAY– AUGUST 2009

Page 7

PA Number Product

PPA1463/023/001 Actonel Once a Week

PPA1500/015/001 Actonel Once a Week

PPA1151/047/002 ADALAT

PPA0465/218/001 Arimidex

PPA0465/236/001 Aromasin

PPA1151/107/001 Asacolon

PPA0465/214/001 Asasantin Retard

PPA1151/109/001 Atacand

PPA1447/038/001 Atacand

PPA1151/110/001 ATACAND Plus

PPA1447/037/001 Atacand Plus

PPA1328/089/001 Augmentin

PPA1473/015/001 Augmentin

PPA0465/230/001 Avelox

PA0966/017/001 Bexmirt



PPA0465/048/003 Canesten Combi Pessary & Cream

PPA0465/204/005 Cardicor



PPA1500/001/001 Cardura XL




PPA1151/102/001 Celluvisc

PPA0465/217/001 Cilest

PPA1151/108/001 Cilest

PPA1328/102/001 CILEST

PA0540/097/003 Clexane Multi Dose

PA1334/001/002 Clindamycin

PA1334/001/002 Clindamycin

PPA0465/226/001 Co-Diovan



PPA1151/122/001 Colofac

PPA1463/024/001 Coversyl Arginine






PPA1500/012/001 Coversyl Arginine Plus

PA Number Product

PPA1328/081/001 Cozaar




PPA1500/020/001 COZAAR

PPA1500/020/002 COZAAR

PPA1328/091/001 COZAAR Comp

PPA1328/091/002 COZAAR Comp

PPA1447/011/002 CREON

PPA1473/018/001 Creon

PPA1562/008/002 Creon

PPA1500/002/001 Crestor

PPA1500/021/001 Detrusitol SR

PPA0465/093/002 Diflucan

PPA1328/092/001 Ditropan

PPA1328/092/002 Ditropan

PPA1463/022/001 Dovobet Ointment

PPA1463/020/001 Dovonex

PPA1328/116/001 Dyazide

PA0281/136/003 Efaxil

PPA1328/118/001 Efexor

PPA1151/076/004 Efexor XL

PPA1151/076/005 Efexor XL

PPA1328/103/001 Elantan LA



PPA1151/117/001 Epilim Enteric Tablets

PPA0465/227/001 Ezetrol

PPA0465/231/001 Fucibet Cream

PA0566/031/009 Glucose

PA0566/031/010 Glucose

PPA1328/094/001 Gopten

PPA0465/220/001 Half Inderal LA

PPA1328/025/002 Ikorel

PPA1500/028/001 Imdur

PPA0465/070/004 IMIGRAN Ftab

PPA1151/112/001 IMODIUM Plus

PPA1151/094/001 IMPLANON

PPA0465/220/002 Inderal LA

PPA1328/106/001 Inderal LA

PPA0465/223/001 Inegy

PPA0465/223/002 Inegy

PPA0465/223/003 Inegy


HUMAN PRODUCT NEW NATIONAL AUTHORISATIONS ISSUED CONTINUED

Page 8

PA Number Product

PPA1463/010/001 ISTIN

PPA1463/010/002 ISTIN

PPA1151/046/003 Klacid

PPA1500/025/001 Klacid LA

PPA1151/115/001 Lamictal





PPA1151/025/002 LEXAPRO

PPA1151/025/003 LEXAPRO

PPA1328/084/001 Lexapro





PPA0465/229/001 Lipantil

PPA1328/083/003 Lipitor




PPA1562/010/001 LIPITOR




PPA1151/103/001 Livial

PPA0465/234/001 Loceryl

PPA1463/021/001 Losec MUPS



PPA1473/019/001 Losec Mups




PPA0465/242/001 Macrodantin

PPA1151/088/001 Minocin SA

PPA1151/089/001 Movicol



PA1128/008/001 Moxelle

PPA0465/216/001 Mycostatin

PPA0465/219/001 NATRILIX SR

PPA1151/096/001 Natrilix SR

PA Number Product

PPA1500/029/001 Neurontin

PPA1500/029/002 Neurontin

PPA1328/029/002 Nexium



PPA1151/106/001 Nicorette

PPA1151/106/002 Nicorette

PPA1151/106/003 Nicorette Freshmint

PPA1151/106/004 Nicorette Freshmint

PPA1328/109/001 Nolvadex D

PPA1151/114/001 Non Drowsy Sinutab

PA0979/032/012 Nurofen Liquid

PA0979/032/013 Nurofen Liquid

PA0074/057/001 Omeprazole

PA0074/057/001 Omeprazole

PPA1463/025/001 Omnexel

PPA1151/116/001 One-Alpha



PA0095/007/006 Paralink Six Plus Paracetamol 250 mg/5 ml solution

PPA1328/098/001 Pariet




PPA0465/235/001 Pentasa

PPA1151/092/001 PENTASA

PPA1328/117/001 Pepcid

PPA1328/111/001 Premarin

PPA1328/111/002 Premarin

PPA1562/007/001 Prempak-C

PPA1562/007/002 Prempak-C

PA0754/005/001 Propofol TechnoPharm Ampoule

PA0754/005/002 Propofol TechnoPharm Vial

PPA1328/001/002 Protium





PPA0465/233/001 Provigil

PPA0465/233/002 Provigil

PPA1328/113/001 PULMICORT Turbohaler

PPA1328/113/002 PULMICORT Turbohaler

PPA1328/099/001 REDUCTIL


HUMAN PRODUCT NEW NATIONAL AUTHORISATIONS ISSUED CONTINUED

Page 9

PA Number Product




PPA0465/240/001 Scheriproct

PPA1151/113/001 Senokot

PPA1151/006/003 Seretide 100 Diskus

PPA1151/034/002 SEROXAT



PPA1473/026/001 Spiriva

PPA1328/100/001 Sporanox

PPA1463/018/001 Sporanox

PPA0465/238/001 Stemetil

PA0979/057/001 Strepsils Antiseptic

PA0979/058/001 Strepsils Throat

PPA0465/225/001 Symbicort Turbohaler

PPA0465/225/002 Symbicort Turbohaler

PPA1151/111/001 SYNDOL

PPA0465/224/001 Tambocor

PPA0465/237/001 Tavanic

PPA1328/107/001 Tenoret

PPA1500/016/001 Tenoret

PPA1328/108/001 Tenoretic

PPA1500/017/001 Tenoretic

PPA1328/110/001 Tenormin

PPA1328/110/002 Tenormin

PPA1151/118/001 Teveten

PPA1328/101/003 Tildiem LA

PPA1328/101/004 Tildiem LA

PPA1328/101/001 Tildiem Retard

PPA1328/101/002 Tildiem Retard

PPA0465/215/001 Traxam

PPA0465/163/005 Tritace

PPA1151/059/001 Ursofalk

PPA0465/221/001 VALCYTE

PPA1473/022/001 Ventolin Evohaler



PPA1328/104/001 Xatral

PPA1473/013/001 XATRAL

PPA1500/024/001 Xatral

PPA1328/114/001 XYZAL

PPA1463/019/001 XYZAL

PA Number Product

PPA1473/023/001 Xyzal

PPA1151/057/002 Zanidip

PPA1328/042/002 ZANIDIP

PPA1473/024/001 Zanidip

PPA1328/105/001 Zantac

PPA1328/105/002 Zantac

PPA1328/112/001 Zestril











PPA1500/006/001 Zimovane

PPA0465/207/002 Zispin SolTab

PPA0465/207/003 Zispin SolTab

PPA1328/115/001 ZISPIN SolTab 30mg

PPA1500/030/001 Zocor

PPA1500/030/002 Zocor

PPA1500/030/003 Zocor

PPA1500/014/001 Zomig

PPA1500/014/002 Zomig Rapimelt

PPA1328/078/001 Zoton Fastab

PPA1328/078/002 Zoton Fastab


HUMAN PRODUCT DECENTRALISED AUTHORISATIONS ISSUED MAY–AUGUST 2009

Page 10

PA Number Product

PA1049/006/001 Abstral




























PA0521/016/002 Albunorm 20%

PA0521/016/001 Albunorm 5%

PA0126/189/001 Amidex

PA0585/036/001 Anastrozole

PA0167/131/002 ARTISS Powders and Solvent for Sealant

PA0167/131/002 ARTISS Powders and Solvent for Sealant

PA0167/131/001 ARTISS Solutions for Sealant

PA0167/131/001 ARTISS Solutions for Sealant

PA1547/002/003 Blopress Plus

PA1547/002/004 Blopress Plus

PA1454/001/001 Buplex

PA1454/001/002 Buplex

PA1454/002/001 Buplex Rx



PA Number Product


PA0566/054/001 Cefuroxime


PA1445/004/001 Cetirizine Aurobindo

PA0711/166/001 Clodel

PA0568/022/002 Coversyl Arginine Plus

PA1419/001/001 Draxmibi

PA0585/037/001 Escitalopram




PA0749/041/001 Fluconazole Teva solution for infusion

PA1390/007/001 Gemcitabine

PA1390/007/002 Gemcitabine

PA0623/012/001 Gemcitabine medac



PA0711/155/001 Irbesan



PA1226/007/001 Irinotecan hydrochloride trihydrate

PA0623/013/001 Irinotecan medac

PA1380/021/001 Irkartaban



PA0865/017/001 Konverge



PA1469/001/001 Lercanidipine hydrochloride

PA1469/001/002 Lercanidipine hydrochloride

PA0566/050/001 Levofloxacin

PA0711/152/001 Levofloxacin

PA0126/171/002 Lochol

PA0126/171/002 Lochol

PA0126/171/003 Lochol

PA0126/171/003 Lochol

PA1380/005/001 Luvinsta

PA1380/005/002 Luvinsta

PA0577/109/001 Myclovear

PA1380/039/001 Mycophenolate Mofetil

PA0577/107/001 Mytanyl




HUMAN PRODUCT DECENTRALISED AUTHORISATIONS CONTINUED

Page 11

PA Number Product


PA0749/078/001 Nebtev

PA0577/106/001 Nelet

PA0678/071/016 NiQuitin Mini Mint

PA0678/071/017 NiQuitin Mini Mint

PA1380/033/001 Noctissin

PA1380/033/002 Noctissin

PA1474/009/001 Ovogrel

PA1422/004/001 Oxaliplatin


PA0749/073/001 Oxcarbazepine TEVA



PA0913/015/012 Palladone




PA0711/118/004 Pendrex

PA0568/022/001 Perindopril tert-butlyamine/Indapamide Servier

PA0568/023/001 Perindopril tert-butylamine/Indapamide Servier

PA1339/001/001 Piperacillin with Tazobactam

PA1339/001/002 Piperacillin with Tazobactam

PA1130/016/001 Proxal

PA1380/018/001 Quelor

PA1380/018/002 Quelor

PA1380/018/003 Quelor

PA1380/018/004 Quelor

PA1380/018/005 Quelor

PA0711/156/001 Quetex

PA1380/020/001 Riluzole Actavis

PA1327/013/001 Rivastigmine Orion




PA1330/003/001 Scippa

PA1330/003/002 Scippa

PA1330/003/003 Scippa

PA1330/003/004 Scippa

PA0568/023/002 Teraxans

PA0585/038/001 Topotecan Pliva

PA1498/001/001 Tradorec XL

PA1498/001/002 Tradorec XL

PA1560/001/001 Trostad

PA Number Product

PA1380/013/001 Valaciclovir Actavis



PA0290/079/001 Vigamox

PA1380/035/001 Zolmiles





HUMAN PRODUCT MUTUAL RECOGNITION AUTHORISATIONS ISSUED MAY–AUGUST 2009

Page 12

PA Number Product

PA0573/002/002 Budenofalk

PA0577/030/002 Diaclide MR

PA0577/112/001 Gerformin



PA1530/001/001 Haemopressin

PA0566/030/005 Hartmann's

PA1347/007/001 Losartan/Hydrochlorothiazide Krka

PA1347/007/002 Losartan/Hydrochlorothiazide Krka

PA0002/069/002 Perfalgan

PA1380/058/001 Raporsin

PA0126/185/001 Seroquin




PA1380/062/004 Simcovas



PA Number Product


PA0711/179/001 Sitrane

PA0711/179/002 Sitrane

PA1380/067/001 Tizaflex

PA1380/067/002 Tizaflex

PA1063/035/001 Tizanidine

PA1063/035/002 Tizanidine

PA1380/063/001 Velexor




PA0566/053/001 Water for Injections

PA1302/002/001 Xefo

PA1302/002/002 Xefo

PA1302/002/004 Xefo Rapid

HUMAN PRODUCT AUTHORISATIONS WITHDRAWN MAY–AUGUST 2009

PA Number Product

PA0144/010/001 Acetoxyl

PA0144/010/003 Acetoxyl 10

PA0144/010/002 Acetoxyl 5

PA0144/028/001 Acnegel

PA0002/018/001 Adcortyl in Orabase 0.1% w/w oromucosal paste

PA1330/002/001 Alendronic Acid 70mg 'once weekly'

PA0021/055/001 ALEVE

PA0021/052/001 Alka Rapid Crystals

PA1327/001/001 Alprox

PA0711/095/001 Amoxicillin/Clavulanic Acid 250/125mg Film-coated

PA0844/003/001 Anapolon

PA0144/017/004 Anthranol 0.4

PA0144/017/001 Anthranol 1.0

PA0144/017/002 Anthranol 2.0

PA1410/036/001 Aspro C Effervescent Tablets

PA0501/001/001 Ayrtons Antiseptic Ointment

PA0126/160/002 Benprotan

PA0144/025/001 Brasivol Fine

PA0144/025/002 Brasivol Medium

PA0187/061/003 Cabaser 4mg Tablets

PA Number Product

PA0711/093/001 Calcil



PA0585/019/002 Cholstat 20mg tablets

PA0585/019/003 Cholstat 40mg tablets

PPA1328/074/001 CIPROXIN

PA1410/015/003 Climara

PA0979/003/001 Codis Dispersible Tablets, 500mg Aspirin, 8mg Codeine

PA0100/001/007 Colomycin

PPA1328/022/002 Coversyl

PA0979/004/001 Dettol Antiseptic

PA0007/053/001 Dexa-Rhinaspray Duo

PA0289/009/001 DIABEX

PPA0465/045/001A Diamicron

PA0979/008/001 Disprol Paracetamol Oral Suspension

PA0979/008/002 DISPROL SOLUBLE PARACETAMOL

PA0915/012/001 DOXAZOSIN DISPHAR



PA0144/012/002 Driclor


Page 13

HUMAN PRODUCT AUTHORISATIONS WITHDRAWN CONTINUED

PA Number Product

PA1077/105/001 Duagen

PA0748/025/001 EPREX

PA0748/025/002 EPREX

PA0748/025/003 EPREX

PA0282/078/001 EQUORAL




PA1410/017/001 Fludarabine Phosphate

PA1380/003/001 Fludarabine Phosphate Actavis

PA0118/048/001 Fortinol LA

PA0118/048/002 Fortinol LA

PA0711/114/001 Galtam

PA0711/114/002 Galtam

PA0711/114/003 Galtam

PA0988/002/001 Gammaderm 200mg/g Cream

PA0521/014/001 Gammanorm

PA1380/019/001 Glemide




PA0002/008/002 Graneodin Ointment

PA0002/053/003 Half Capozide

PA0966/009/005 Hyraz 1 mg and 2 mg Tablets. Titration pack.

PA0966/009/004 Hyraz 1 mg Tablets




PA0043/006/001 Ibuprofen

PA0566/019/012 Intralipid

PA0566/019/001 INTRALIPID 10%,100ml Emulsion for Infusion




PA0566/019/007 INTRALIPID 30%, 333ml Emulsion for Infusion

PA0144/031/002 Isotrex Cream 0.05%

PA0144/031/003 Isotrex Cream 0.10%

PA0144/042/001 Isotrexol Cream 0.05 %

PA0144/042/002 Isotrexol Cream 0.10 %

PA0002/009/002 Kenacomb Cream

PA0002/009/001 Kenacomb Ointment

PA0002/033/001 Kenacomb Otic Ointment.

PA0818/004/001 Levonelle

PA Number Product

PA0013/083/003 Lopresor SR

PA0372/010/001 Meloxicam

PA0372/010/002 Meloxicam

PA0022/078/001 Meningitec

PA0240/008/002 Meta-Iodobenzylguanidine

PA0409/019/001 Methadone

PA1317/001/001 Metronidazole/Metrovex

PA0544/024/002 M-M-R ™ II Powder and Solvent for Solution for Inj

PA0544/024/001 M-M-RTM II Powder and Solvent for Solution for Inj

PA0979/032/004 Nurofen 200 mg Meltlets

PA0943/007/001 OCCLUSAL LS

PA0144/022/005 Oilatum Fragrance Free

PA0074/054/003 ONDANSETRON

PA0074/054/004 ONDANSETRON


PA0970/016/001 Paludrine Tablets 100mg

PA0144/011/008 PanOxly 5

PA0144/011/010 Panoxyl 10

PA0144/011/009 PanOxyl 5

PA0144/011/011 PANOXYL AQUACREAM

PA1380/045/001 Percarnil

PA0144/030/001 Polytar Anti-fungal

PA0144/004/001 Polytar Plus

PA1161/005/001 PREDENEMA

PA0002/034/002 Pronestyl

PA0144/045/001 Pruricalm

PA0988/001/001 Psorimed

PA0966/012/001 QUINAPRO




PA0506/017/001 Radian B Muscle Lotion

PA0506/016/001 Radian B Pain Relief Spray

PA0593/012/001 RANITISTAD 150

PA0593/012/002 RANITISTAD 300

PA0535/006/008 Reminyl XL (starter pack)

PA0688/012/001 Respintel








Page 14

PA Number Product

PA0002/074/001 REVIA

PA0688/006/001 Risperidone








PA0050/068/025 ROFERON-A PRE-FILLED SYRINGE 18MIU/0.5ML

PA1380/004/005 Ropinirole

PA0144/035/001 Rosac Metronidazole Gel

PA0144/014/001 SARNOL

PPA1328/034/001 Serc

PA0593/036/001 Simvastad

PA0593/036/002 SIMVASTAD



PA1081/002/001 Simvastatin



PA1081/001/001 Simvastatin ct




PA0819/028/001 Simvastatin SH

PA0819/028/002 SIMVASTATIN SH



PA0240/018/001 SODIUM IODIDE



PA0144/032/001 SOLABAN A + B

PA0678/061/001 Solpaflex Sustained Release

PA0144/007/001 Spectraban 15

PA0144/021/001 Spectraban 4

PA0144/027/001 Stiefel Acne

PA0144/041/001 Stiefel Anti-Perspirant Solution

PA0144/023/002 Stiefel Dry Skin

PA0144/044/001 Stiefel Emollient

PA0144/043/001 Stiefel Sunblock Lotion

PA0144/016/002 Stiemycin

PA1063/022/001 Sumatriptan Niche

HUMAN PRODUCT AUTHORISATIONS WITHDRAWN CONTINUED

PA Number Product

PA1063/022/002 Sumatriptan Niche

PPA1328/038/001 Symbicort Turbohaler 100/6 Inhalation Powder

PA0144/034/001 TARMED

PA0144/036/001 Tarmed AF

PA0240/031/001 THERACAP

PA0405/054/001 Topamat Film Coated Tablets




PA0566/023/001 VAMIN 14 Electrolyte - Free Solution for Infusion,


PA0566/022/002 VAMIN 14 Solution for Infusion, 1000ml

PA0566/022/001 VAMIN 14 Solution for Infusion, 500ml



PA0566/012/002 Vamin 9 Glucose

PA0566/012/003 Vamin 9 Glucose

PA0711/161/005 Vedixal 150 mg Tablets



PA0030/015/002 VIOFORM HYDROCORTISONE

PA0030/015/001 VIOFORM-HYDOCORTISONE

PA0144/040/001 WARTICON

PA1027/002/002 WinRho SDF

PA1027/002/003 WinRho SDF

PPA1328/004/001 Zinnat

PA1332/008/001 ZOPICLONE

PPA1151/003/001A Zoton

PPA1151/003/002A Zoton

PPA0465/017/001A Zyloric


VETERINARY PRODUCT AUTHORISATIONS ISSUED MAY–AUGUST 2009

VETERINARY PRODUCT AUTHORISATIONS WITHDRAWN MAY–AUGUST 2009

Page 15

VPA Number Product

10987/070/001 Animec 0.8 mg/ml Oral Solution for Sheep

10987/081/001 Chanectin 0.8 mg/ml Oral Solution for Sheep

10879/036/001 Clindamycin 300 mg Tablets

10999/124/001 Closamectin Pour-on Solution for Cattle

10988/076/002 Effipro 134 mg spot-on Solution for medium dogs

10988/072/001 Effipro 2.5 mg/ml Cutaneous Spray Solution for Cats and Dogs

10988/076/003 Effipro 268 mg spot-on Solution for large dogs

10988/076/004 Effipro 402 mg spot-on Solution for very large dogs

10988/075/001 Effipro 50 mg spot-on Solution for cats

10988/076/001 Effipro 67 mg spot-on Solution

10999/111/001 Endectomectin 1% w/v Solution for Injection

10786/001/001 Enro-K 10% Oral Solution

10774/001/001 Enrox Flavour 15 mg Tablets

10774/001/003 Enrox Flavour 150 mg Tablets

10774/001/002 Enrox Flavour 50 mg tablets

10815/008/001 Florkem 300 mg/ml Solution for Injection

10782/007/001 HydroDoxx 500 mg/g Powder for Use in drinking water

10786/004/001 Kariflox 25 mg/ml Oral Solution for Calves

10786/003/001 Kariflox 5 mg/ml Oral Solution for Piglets

10782/006/002 Pharmasin 100 mg/g Premix for medicated feeding stuff

10782/001/002 Pharmasin 20 mg/g Oral Granules

10782/006/003 Pharmasin 250 mg/g Premix for medicated feeding stuff

VPA Number Product

10988/071/002 Powerflox 100 mg/ml Solution for Injection

10988/071/001 Powerflox 50 mg/ml Solution for Injection

10861/101/001 Propoclear 10 mg/ml Emulsion for Injection

10987/080/001 Topimec 0.8 mg/ml Oral Solution for Sheep

10999/112/001 Ultimectin 1% w/v Solution for Injection

10787/003/001 Unisol 0.5% Oral Solution for Piglets

10787/002/001 Unisol 10% Oral Solution

10787/004/001 Unisol 2.5% Oral Solution for Calves

VPA Number Product

10996/198/001 Cobactan IU 900 mg Intrauterine Suspension

10277/084/001 Intrac

10825/002/001 Johnson forfleas Dog Collar

10996/002/002 Laurabolin

10835/013/001 Lopatol 500mg Tablets

10996/012/001 Nandrolin 25 mg/ml Solution for Injection

10835/024/002 Program Tabelts 204.9mg

VPA Number Product

10835/024/003 Program Tablets 409.8mg

10835/024/001 Program Tablets 67.8mg

10825/014/004 Sentinel Spectrum Tablets for Large Dogs

10825/014/003 Sentinel Spectrum Tablets for Medium Dogs

10825/014/002 Sentinel Spectrum Tablets for Small Dogs

10825/014/001 Sentinel Spectrum Tablets for Very Small Dogs

10861/050/001 Suvaxyn Parvo


Date post:	20-Dec-2016
Category:	Documents
Upload:	doanthuy
View:	228 times
Download:	0 times