MAIL - GOV.UK · PDF fileMAIL 121 September/October 2000 2 MC A MCA NEWS The Committee on Safety of Medicines (CSM) and the MCA have updated the Yellow Card by

MAIL 121

MAIL

The MCA updating service

� Updated Yellow Card and changes implemented to the

company ADR reporting form

� New monographs for the British Pharmacopoeia

September/October 2000

1 MAIL 121 September/October 2000

Items in MAIL give general guidance

and must not be treated as a complete

and authoritative statement of the law

on any particular case. Copies of the

Medicines Act and of the Orders and

Regulations made under the Act

are available from The Stationery

Office bookshops.

ISSN 1360-8738

©

Crown Copyright 2000

* Direct dialling is available to all MCA

staff. Please refer to Appendix 10 for

MCA contact points. Before each

extension quoted simply dial 020-7273.

If you do not know who to contact

please telephone 020-7273 0000.

MAIL is published bimonthly by the

Medicines Control Agency (MCA),

Department of Health, Market Towers,

1 Nine Elms Lane, London SW8 5NQ.

Telephone: 020-7273 0000*

Fax: 020-7273 0353

Home Page:

h t t p : / / w w w . o p e n . g o v . u k / m c a /

mcahome.htm

Editor: Ed Scully

Deputy Editor: Hilke Dettmeier

Distribution: Ronke Omotayo

Design: Paul Hylton

Layout: Hilke Dettmeier

Contents MAIL 121

ED SCULLY

The Editor, MAIL, 10th floor, Market Towers.

Telephone 020-7273 0345.

MCA NEWS ...................................................................................... 2

Leading issues ................................................................................ 2

Enforcement ................................................................................... 3

PHARMACOPOEIAL NEWS ...................................................... 4 .

British Pharmacopoeia ................................................................... 4

PUBLICATIONS ............................................................................. 6

APPENDICES .................................................................................. 7

M C A

WELCOME to MAIL 121. Our leading

issue this month concerns the updated

Yellow Card launched on 7 September

2000 and the changes that have been implemented

to the company ADR reporting form. We include

an example of the new form at Appendix 2, and

also provide a useful list of articles in previous MAIL

editions relating to ADR reporting. Concerning the

British Pharmacopoeia and the British

Pharmacopoeia (Veterinary), we list in this issue

preparations for which the development of new

monographs has been initiated, and we invite

manufacturers to submit their comments. Finally,

we have a reminder to readers that Amendments

No. 1 to the British Pharmacopoeia 2000 will be

issued in November together with an updated version

of the CD-ROM.

MAIL 121 September/October 2000 2

MCA NEWSM C A

The Committee on Safety of

Medicines (CSM) and the MCA

have updated the Yellow Card by

modifying some of the information

requested about suspected

adverse drug reactions from health

professionals. We are now

requesting the patient’s initials and

age instead of the patient’s name

and date of birth. This removal of

patient personal identifiers

allows reporting without gaining

express patient consent.

Changes implemented to the

Yellow Card for health

professionals

The updated Yellow Card has

been changed as follows:

• Personal patient identifiers

have been removed. Instead of

asking for the patient’s name and

date of birth we now only require

patient initials and age.

• A local identification number is

requested. This may be a practice

or hospital number or any

reference number which enables

the reporter, but not the MCA, to

identify the patient if follow up

information is required.

• Tick boxes have been added to

the Yellow Card to help the reporter

identify whether the reaction was

serious or not. This is in line with

the serious adverse reaction

Updated company ADR reporting form

‘A reportable adverse drug

reaction (ADR) requires the

following minimum

information:

b) an identifiable patient –

The patient can be identified by

initials or patient number, or date

of birth (or age information if date

of birth not available) or sex. The

information should be as complete

as possible’.

It is now felt more appropriate to

use patient initials and age, rather

than name and date of birth, when

reporting suspected adverse drug

reactions to the CSM/MCA.

THE updated Yellow Card was launched on 7 September 2000. This new card is in accord with

the recently published General Medical Council (GMC) guidelines on confidentiality.

criteria given in Annex 1 of the MCA

EuroDirect Publication No.

PhVWP/108/99.

Changes implemented to the

Company ADR Reporting Form

These changes have been extended

to company reporting. For company

reporting, the patient’s name and date

of birth have been removed but age

and/or initials are still required (and

local identification number if given by

reporter). A copy of the updated

company reporting form is included

in Appendix 2.

Reminder of the legal

pharmacovigilance obligations by

MA holders

Statutory pharmacovigilance

obligations for marketing

authorisation (MA) holders are

through the European Community

(EC) Regulation 2309/93 and

Directive 75/913. In UK law they

are included as The Medicines for

Human Use (Marketing

Authorisation etc.) Regulations

[SI 1994/3144]. The Notice to

marketing authorisation holders

pharmacovigilance guidelines

summarises the relevant EC

legislation. This document is

included in The rules

governing medicinal products

in the European Union (Volume

9) and is available as MCA

EuroDirect Publication No.

PhVWP/108/99. The recent

changes to personal patient

identifier details are still

encompassed by these

guidelines, as follows:

This removal of

patient personal

identifiers allows

reporting without

gaining express

patient consent.

Leading issues

continued on page 3


MCA NEWS

It should be noted that previous MAIL articles might

include advice that has since been superseded by

subsequent articles.

• MAIL 119, May/June 2000, Reminder –

pharmacovigilance regulatory obligations

• MAIL 105, Jan/Feb 1998, Handling of Clinical trial

ADRs – Reminders!

• MAIL 105, Jan/Feb 1998, Update on the Medical

Dictionary for Regulatory Activities (MedDRA).

• MAIL 104, Nov/Dec 1997, Studying the safety of

marketed medicines – Guidelines for company – sponsored

safety assessment of marketed medicines (SAMM).

• MAIL 101, May/June 1997, New ICH guideline on

periodic safety update reports.

• MAIL 100, Mar/Apr 1997, Reporting of pregnancy

outcomes derived from prospective registries.

• MAIL 100, Mar/Apr 1997, New handling of clinical trial

ADRs.

• MAIL 96, Jul/Aug 1996, Reminder about adverse

reaction reports notified to companies by regulatory

authorities.

• MAIL 96, Jul/Aug 1996, Important reminders about

clinical trial exemptions.

Previous MAIL editions containing information relating to the reporting of ADRs

• MAIL 95, May/June 1996, ADR reporting for authorised

medicinal products – Reminders!

• MAIL 90, Jul/Aug 1995, Anonymised Single Patient

Prints and reminder of definition of ‘serious’.

• MAIL 88, Mar/Apr 1995, Clinical trials – adverse

reaction reporting by companies.

• MAIL 87, Jan/Feb 1995, Pharmacovigilance in the new

European System.

• MAIL 87, Jan/Feb 1995, AEGIS update – new version

of AEGIS includes electronic ADR reporting for industry.

• MAIL 85, Sep/Oct 1994, Acknowledgement of ADR

reports.

• MAIL 84, Jul/Aug 1994, ADR reporting for reactions

occurring outside the UK.

• MAIL 82, Mar/Apr 1994, ADR reporting for licensed

products.

For further information write to us at The

Pharmacovigilance Group, Post-Licensing Division,

Medicines Control Agency, Market Towers, 1 Nine Elms

Lane, London SW8 5NQ or phone the National Yellow

Card Information Service on Freephone 0800-7316789.

Alternatively visit the MCA website at www.open.gov.uk/

mca/mcahome.htm.

Leading issues

ON 6 JUNE 2000 at Maidenhead Magistrates Court, James

McDonald pleaded guilty to one count of placing a relevant

medicinal product (melatonin) on the market without a

marketing authorisation contrary to Schedule 3 paragraph

(1) of the Medicines for Human Use (Marketing

Authorisations etc.) Regulation 1994 and a further count

of possessing melatonin knowing or having reasonable

cause to believe that it was or is intended to be placed on

the market contrary to Schedule 3 paragraph (2) of the

same Regulations.

In addition he pleaded to two counts of selling

melatonin, not being a medicinal product on the general

sale list, by retail in contravention of Section 52 of the

Medicines Act 1968 contrary to Section 67 of the Medicines

Act 1968 and one count of unlawfully supplying a

controlled drug of Class C namely DHEA to another

contrary to Section 5(2) of the Misuse of Drugs Act 1971.

McDonald who worked as a nutritionist and had been

selling both melatonin and DHEA through a company

named Nutrizec was sentenced at Reading Crown Court

on 28 July 2000. Judge Critchlow commented that

McDonald had been aware that his actions were unlawful

and that the matter should be regarded as serious but was

content that he would not re-offend and imposed a

community service order of 50 hours on each count to run

concurrently.

If you would like to know more about the work of

our Enforcement Group, please contact Mrs Jackie

Gearey on 020-7273 0025.

Prosecutions

Enforcement

continued from page 2


British Pharmacopoeia 2000 and British Pharmacopoeia

(Veterinary) 2000

FROM 1 December 2000 the current

edition of the British

Pharmacopoeia will be the British

Pharmacopoeia 2000 as amended

by Amendments No 1 and the current

edition of the British

Pharmacopoeia (Veterinary) will be

the British Pharmacopoeia

(Veterinary) 2000. The two

publications are presented together

as a package which includes the CD-

ROM on which the full text of all

three volumes, together with that of

British Approved Names 1999, is

searchable.

Amendments No 1 to the

British Pharmacopoeia 2000 will be

issued in November together with an

updated version [4.1] of the CD-ROM.

For technical matters concerning

these publications please contact

the scientific editor-in-chief, Miss

Marie Rabouhans, on

020-7273 0560 or other members

of the BP Secretariat (see contact

points in Appendix 10). The

publications are available from

Government Bookshops or from

The Stationery Office, PO Box 29,

Norwich NR3 1GN, telephone

0870-600 5522, fax 0870-600

5533.

For information regarding

network licences please contact the

Electronic Publishing Sales Office

at the above address.

British Pharmacopoeia

PHARMACOPOEIAL NEWS

DEVELOPMENT of new monographs for the

preparations listed below has been initiated. Known

manufacturers are being invited to co-operate with us

in the development of these monographs for

publication. We invite any manufacturer who has not

already received a letter from us to submit proposals

New monographs for the British Pharmacopoeia and British

Pharmacopoeia (Veterinary)

for appropriate standards and analytical procedures

together with suitable samples (please see

Supplementary Chapter III C, British Pharmacopoeia

2000).

Note: (V) denotes a preparation intended for

inclusion in the BP (Vet).

Acitretin Capsules

Albendazole Oral Suspension (V)

Albendazole Oral Suspension with Minerals (V)

Aminophylline Modified-release Tablets

Amlodipine Tablets

Carbomer Eye Drops

Carmellose Gelatin Paste

Cefamandole Injection

Ceftazidime Injection

Cetirizine Tablets

Cetirizine Oral Solution

Cilastatin and Imipenem Injection

Co-amoxiclav Injection

Cocaine Eye Drops

Co-codamol Capsules

Co-codamol Effervescent Tablets

Co-cyprindiol Tablets

Conjugated Estrogen Tablets

Conjugated Estrogens Vaginal Cream

Dexamethsone and Neomycin Ear Spray

Diclofenac Capsules, Modified-release

Enalapril Tablets

Fenoterol and Ipratropium Pressurised Inhalation

Gentamicin and Hydrocortisone Ear Drops

Glycerol Eye Drops

Haloperidol Oily Injection

continued on page 5


Alfentanil Injection

Alfentanil Intensive Care Injection

Amiloride and Cyclopenthiazide Tablets

Amphotericin Intravenous Infusion

Azelastine Nasal Spray

Budesonide Insufflation

Budesonide Nasal Spray

Budesonide Nebuliser Solution

Budesonide Pressurised Inhalation

Bupivacaine Hypertonic Injection

Buprenorphine Injection

Buprenorphine Tablets

Calcitriol Capsules

Calcitriol Injection

Cefalexin Oily Injection (V)

Cefixime Paediatric Oral Suspension

Cefixime Tablets

Chlorhexidine and Neomycin Nasal Cream

Clindamycin Topical Solution

Clioquinol and Flumetasone Ear Drops

Clotrimazole and Hydrocortisone Cream

Clozapine Tablets

Co-beneldopa Capsules, Modified-release

Co-phenotrope Tablets

Diltiazem Capsules, Long-acting

Droperidol Oral Liquid

Erythromycin Gastro-resistant Capsules

Erythropoetin Injection

Estradiol and Norethisterone Tablets

Estradiol and Norethisterone Transdermal Patch

Etynodiol Diacetate Tablets

Felodipine Tablets

Fentanyl Transdermal Patch

Flumazenil Injection

Fluticasone Propionate Insufflation

Fluticasone Propionate Liquid Nasal Spray

The following items were initiated some time ago, but proposals (data and samples) are still awaited. If you have

an interest in any of these items, you are invited to submit proposals as noted above.

British Pharmacopoeia

Isosorbide Mononitrate Modified-release Tablets

Ivermectin Injection (V)

Ivermectin Oral Solution (V)

Ivermectin Paste (V)

Ivermectin Pour-on (V)

Medroxyprogesterone Injection

Medroxyprogesterone Tablets

Mefenamic Acid Tablets

Methylthioninium Chloride Injection

Miconazole and Hydrocortisone Nitrate Cream

Miconazole and Hydrocortisone Nitrate Ointment

Nifedipine Modified-release Tablets

Nizatidine Capsules

Nizatidine Injection

Potassium Phosphate Injection

Propofol Injection

Simvastatin Tablets

Sodium Chloride Aqueous Spray, Sterile

Sodium Picosulphate Oral Solution

Streptokinase and Streptodornase Topical Powder

Sumatriptan Injection

Sumatriptan Nasal Spray

Sumatriptan Tablets

Fluticasone Propionate Press. Inhalation

Ibuprofen Tablets, Slow

Indapamide Tablets, Modifed-release

Interferon Alfa Injection

Iopamidol Injection

Iopamidol Oral Solution

Iopamidol Oral Suspension

Ipratropium Nebuliser Solution

Lidocaine Ointment

Lithium Citrate Tablets, Slow

Malathion Lotion (Aqueous and Alcoholic)

Malathion Shampoo

Mefloquine Tablets

Metronidazole (Benzoate) Oral Suspension

Minocycline Capsules, Slow

Morphine Sulphate Modifed-release Oral Suspension

Morphine Sulphate Modified-release Capsules

Netilmicin Injection

Omeprazole Capsules

Oxybutynin Oral Solution

Paracetamol and Metoclopramide Tablets

Paracetamol and Metoclopramide Oral Powder

Ramipril Capsules

Salbutamol Tablets, Slow

Senna and Ispaghula granules

Senna Oral Solution

Simeticone Suspension for Infants

Sodium Perborate Mouthwash

Sulfadoxine and Pyrimethamine Tablets

Terbutaline Pressurised Inhalation

Terbutaline Sulphate Insufflation

Testosterone Enantate Injection

Tiaprofenic Acid Modifed-release Capsules

Tiaprofenic Acid Tablets

Ticarcillin and Clavulanic Acid Injection

Zopiclone Tablets

For further information please contact Mrs Hillary Judd on 020-7273 0558.

continued from page 4

PHARMACOPOEIAL NEWS


PUBLICATIONS

EuroDirect Publications

SINCE the last isues of Mail (July/

August 2000), the following

guidelines were released for

consultation:

• 269/95 Note for guidance on

plasma-derived medicinal products

Rev. 2 (BWP).


organisation of Common Technical

Document for the registration of

pharmaceuticals for human use

(ICH).

• 1940/00 Maintenance of note for

guidance on impurities: residual

solvents - permissible daily exposure

(PDE) for Tetrahydrofuran and N.

Methylpyrrolidone (ICH).

• EC10/00 Note for guidance on

Good Manufacturing Practice for

active pharmaceutical ingredients.

• 1143/00 Position statement on

the use of tumorigenic cells of human

origin for the production of biological

and biotechnological medicinal

products (BWP).

• 2284/99 Points to consider on

clinical investigation of medicinal

products for the management of

Crohn’s disease (draft 5) (EWP).


evaluation of anticancer products in man

(EWP).

• 602/95 Points to consider in the

assessment of an anti-HIV medicinal

product Rev. 2.


medicinal gases: pharmaceutical

documentation (draft) (QWP).

The following documents were adopted:


repeated dose toxicity (SWP).

• 2711/99 Note for guidance on clinical

investigation of medicinal products in

the paediatric population (ICH).


choice of control group in clinical

trials (ICH).

• 1080/00 Concept paper on the

development of a CPMP note for

guidance on the quality of water for

pharmaceutical use (draft) (QWP).


pharmacokinetics and

pharmacodynamics in the

development of antibacterial

medicinal products (EWP).


plasma-derived medicinal products -

revision of section 3.2.5 of CPMP/

BWP/269/95 Rev. 2 - albumin and

other plasma-derived products used

in the manufacture and formulation

of medicinal products (BWP).


switching between superiority and

non-inferiority (EWP).

For further information about

our EuroDirect Publication Service

please contact Ms Tania Pereira,

Room 10-238, Market Towers.

Telephone 020-7273 0352, fax

020-7273 0353.

Recent MLX and Statutory Instruments

THE following MLX has been

published since our last issue:

• MLX 266 - Licence Fees for

Medicinal Products for Human Use

Only: Proposals relating to the

introduction of a new fee category

for regulatory assistance in

connection with outgoing mutual

recognition applications.

Copies of this document are

available from the MCA Information

Centre on 020-7273 0228/0352, fax

020-7273 0353 or on the MCA web site.

The following Statutory Instruments

have been published since our last

issue:

• The Prescription Only Medicines

(Human Use) Amendment Order 2000

[SI 2000/1917].

• The Medicines (Sale or Supply)

(Miscellaneous Provisions) Amendment

(No. 2) Regulations 2000 [SI 2000/1918].

• The Medicines (Pharmacy and

General Sale-Exemption) Amendment

Order 2000 [SI 2000/1919].

• The Medicines (Sale or Supply)

(Miscellaneous Provisions)

Amendment (No.3) Regulations 2000

[SI 2000/2492].

Statutory Instruments may be

purchased from The Stationery

Office, PO Box 29, Norwich NR3

1GN, telephone 0870-600 5522.

They may also be accessd on the

website at http://www.hmso.gov.uk/

stat.htm.


THE targets for the assessment of new active substances are based on the time from receipt of a valid application to the

date on which the assessment report is completed for submission to the advisory committees.

The graph shows mean assessment time based on new active substance numbers and product licence numbers.

Figures incorporate new active substance applications assessed by the NCE and Biological and Biotechnological Units.

They include incoming NCE mutual recognition applications and the assessment of centralised applications (both parts

A and B) when the United Kingdom is acting as either rapporteur or co-rapporteur.

Abridged applications – net processing times

New active substance applications - mean assessment times

APPENDIX 1


Abridged licensing - additional statistics

THE following graphs provide more detailed information on abridged applications to enable applicants to judge the

length of time applications are taking. All abridged applications are included.

The receipt to assessment figure

represents the mean number of

calendar days that have elapsed

from the date of receipt of an

application to the date of the start

of the assessment of the dossier.

The assessment times for non-

committee cases figure represents

the mean number of calendar days

that have elapsed from the date of

receipt of an application to

the completion of the assessment

report.

The assessment times for

committee cases figure represents

the same information as the

previous figure but is for those

applications scheduled to be seen

by the Committee on Safety of

Medicines.

APPENDIX 1


Variations - Performance

THE targets for processing variations are based on the time from the notified procedure start date (the “acknowledgement”

letter) to the completion of assessment. For Type I variations, this is the time to the “notification with grounds” letter or

“approval” letter. For Type II variations, this is the time to the “request for supplementary information” letter or “approval”

letter.

Performance data reflect all national and Mutual Recognition variations where the UK is a concerned Member State.

Additionally, the following graph shows the number of Mutual Recognition variations, where the UK is a concerned

Member State, at various stages of the procedure. It reflects the total number of variations received, the numbers waiting

a procedure start date or in-process, and the number of procedures completed.

APPENDIX 1


APPENDIX 2


New

m

an

ufactu

rer’s an

d w

holesale d

ealer’s licen

ces

issu

ed

in

Ju

ly an

d A

ugu

st 2000

Fo

r f

urth

er i

nfo

rm

atio

n p

lea

se c

on

ta

ct M

r D

av

id

Kw

ok

ori o

n 0

20

-7

27

3 0

58

5.

APPENDIX 3

Licence

Licence H

older

MA

17872

Medical G

as S

ervices L

im

ited, 1

98 H

igher R

oad, U

rm

ston, G

reater M

anchester, M

41 9

BH

MA

18121

Day’s A

nim

al H

ealth L

td, N

ew

Day H

ouse, F

irst A

venue, W

eston R

oad, C

rew

e, C

heshire, C

W1 6

BE

MS

14717

How

ard A

nd P

alm

er L

td, S

wansea E

nterprise P

ark, C

astell C

lose, L

lansam

let, S

wansea, S

A7 9

FH

WL

10256

Stephar (

UK

) L

td, 3

Waveney P

ark, H

ew

ett R

oad, G

t. Y

arm

outh, N

orfolk, N

R31 0

NN

WL

17862

Orbis C

onsum

er P

roducts L

td, U

nit 3

1 N

orthfields I

nd. E

state, B

eresford A

venue, W

em

bley, M

iddlesex, H

A0 1

NW

WL

18072

Genrx P

harm

aceuticals L

im

ited, T

aylor G

roup H

ouse, W

edgnock L

ane, W

arw

ick,W

arw

ickshire, C

V34 5

YA

WL

18081

Topkins L

td, 6

Station R

oad, H

arpenden, H

erts, A

L5 4

SE

WL

18117

Berkshire W

holesale S

upplies L

td, P

ark P

harm

acy, 4

Cookham

Road, M

aidenhead, B

erkshire, S

L3 8

AH

WL

18183

Salvesen L

ogistics L

td, P

arkhouse I

ndustrial E

state, N

ew

castle-U

nder-L

ym

e, S

taffordshire, S

T5 7

DU

WL

18198

Ratiopharm

(U

K) L

td, 2

440 T

he Q

uadrant, A

ztec W

est, A

lm

ondsbury, B

ristol, B

S32 4

AQ

WL

18203

Maxim

Logistics L

td, 2

Darw

in R

oad, W

illow

Brook E

ast I

ndustrial E

state, C

orby, N

ortham

ptonshire, N

N17 5

XZ

WL

18291

Genplus L

im

ited, U

nit 3

B, L

ancer H

ouse, H

ussar C

ourt, B

ram

bles B

usiness P

ark, W

aterlooville, H

am

pshire, P

07 7

SG

WL

18327

Edenw

est L

td, 1

2a F

allocourt A

venue, L

ondon, N

12 0

EB

AO

8215

Kent P

harm

aceuticals L

im

ited, W

otton R

oad, A

shford, K

ent, T

N23 6

LL

MA

18315

Elan T

ransderm

al T

echnologies (

UK

) L

td, G

em

ini H

ouse, B

artholom

ew

’s W

alk, E

ly, C

am

bridgeshire, C

B7 4

EA

MS

18315

Elan T

ransderm

al T

echnologies (

UK

) L

td, G

em

ini H

ouse, B

artholom

ew

’s W

alk, E

ly, C

am

bridgeshire, C

B7 4

EA

MS

14717

How

ard A

nd P

alm

er L

td, S

wansea E

nterprise P

ark, C

astell C

lose, L

lansam

let, S

wansea, S

A7 9

FH

WI

18250

Schering-P

lough A

nim

al H

ealth D

ivision o

f S

chering-P

lough L

td, B

reakspear R

oad S

outh, H

arefield, U

xbridge, M

iddlesex, U

B9 6

LS

WL

18016

Pharm

aceuticals D

irect L

td, 2

Delta C

lose, W

orcester P

ark, S

urrey, K

T4 7

HR

WL

18174

Selective S

upplies L

im

ited, O

akfield H

ouse, 3

5 P

errym

ount R

oad, H

ayw

ards H

eath, W

est S

ussex, R

H16 3

BW

WL

18246

Mayors H

ealthcare L

im

ited, 1

27 T

he G

rove, S

tratford, E

15 1

EN

WL

18250

Schering-P

lough A

nim

al H

ealth D

ivision O

f S

chering-P

lough L

td, B

reakspear R

oad S

outh, H

arefield, U

xbridge, M

iddlesex, U

B9 6

LS

WL

18263

MediN

et C

orporation L

im

ited, F

loor 1

, C

loister H

ouse, N

ew

Bailey S

t, R

iverside, M

anchester, M

3 5

AG

WL

18264

Richm

ond P

harm

aceuticals L

td, C

oom

b H

ouse, 7

St J

ohn’s R

oad, I

slew

orth, M

iddlesex, T

W7 6

NA

WL

18295

Web P

harm

a L

td, 1

Liddington H

all D

rive, G

uildford, S

urrey, G

U3 3

AF


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Finance Department

Medicines Control Agency

Room 21-145, Market Towers,

1 Nine Elms Lane,

London SW8 5NQ

United Kingdom

VAT No. GBGD 150

All prices are £STERLING. Payment can

only be made by cheque and MUST be in

£STERLING and drawn on a UK bank.

Please make your cheque payable to:


To avoid delays in processing your order,

please can you enter your cheque number in

the box below.

Cheque Number:

(block capitals please)

NAME: ...........................................................................................................................................................................

ORGANISATION: ........................................................................................................................................................

ADDRESS: .....................................................................................................................................................................

POSTCODE: ............................................................. COUNTRY: ...............................................................................

TEL NO: .................................................................... FAX NO: ...................................................................................

TOTAL COST OF ORDER £ .......................................................................................................................................

SIGNED: .................................................................... DATE OF ORDER: ...................................................................

*Any changes in VAT will be passed on

APPENDIX 4


EuroDirect Annual Subscription and Individual Copies Order Form

Annual EuroDirect Subscription - 1 December 2000 - 30 November 2001

Name of Subscriber to be used for mailing purposes........................................................................................

Price per subscription £300.00 VAT at 0%* (includes first class mail/airmail and packaging. For locations outside

the EC please add £50.00 for each subscription). Subscriptions received before 1 November 2000 £275 (outside

EC add £50.00)

Total number of subscriptions requested ...................................... Total Cost £ ...............................................

Retrospective Subscription - 1 December 1993 - 30 November 1999

Name of Subscriber to be used for mailing purposes.......................................................................................

Price per subscription £650.00 VAT at 0%* (includes first class mail/airmail and packaging. For locations outside

the EC please add £50.00 for each subscription).


Order for individual copies of guidelines

Price per guideline £15.00 (unless otherwise stated) VAT at 0%* (includes first class mail/airmail and packaging.

For locations outside the EC please add £2.00 per guideline unless otherwise indicated).


Order for Binders

Price per binder is £4.00 VAT at 0%* (includes first class mail/airmail and packaging. For locations outside the

EC please add £1.25 per binder).

Total number of binders required ..................................................... Total Cost £ ...............................................


should be sent to:

Finance Department



1 Nine Elms Lane,

London SW8 5NQ

United Kingdom






To avoid delays in processing your order,

please can you enter your cheque number in

the box below.

Cheque Number:


NAME: ...........................................................................................................................................................................

ORGANISATION: ........................................................................................................................................................

ADDRESS: .....................................................................................................................................................................


TEL NO: .................................................................... FAX NO: ...................................................................................




VAT No. GBGD 150

APPENDIX 5


MCA VIDEO ORDER FORM

Risk & Benefit’

No. of copies ........................... @ £.35.25 (inc VAT)* £...........................

‘Medicines Under Control’

No. of copies ........................... @ £35.25 (inc VAT)* £...........................

Both videos

No of sets ........................... @ £70.50 (inc VAT)* £...........................

Please add postage and packaging of £1.50 per video £...........................

Total £...........................

Please tick format required: VHS SECAM US Format


NAME: ...........................................................................................................................................................................

ORGANISATION: ........................................................................................................................................................

ADDRESS: .....................................................................................................................................................................


TEL NO: .................................................................... FAX NO: ...................................................................................




Please allow 28 days for delivery from receipt of order, subject to availability.


should be sent to:

Finance Department



1 Nine Elms Lane,

London SW8 5NQ

United Kingdom

VAT No. GBGD 150






To avoid delays in processing your order, please

can you enter your cheque number in the box

below.

Cheque Number:

APPENDIX 6



Annual Reports for 1999

Medicines Act 1968 Advisory Bodies

Price per copy £10.00 VAT at 0%* (includes first class mail/airmail within EC. For locations outside the EC

please add £2.00 for each).



NAME: ...........................................................................................................................................................................

ORGANISATION: ........................................................................................................................................................

ADDRESS: .....................................................................................................................................................................


TEL NO: .................................................................... FAX NO: ...................................................................................





should be sent to:

Finance Department



1 Nine Elms Lane,

London SW8 5NQ

United Kingdom

VAT No. GBGD 150








below.

Cheque Number:

APPENDIX 7



Manufacturer’s Licences and

Wholesale Dealer’s Licences Registers

Manufacturer’s Licences Register




Wholesale Dealer’s Licences Register





NAME: ...........................................................................................................................................................................

ORGANISATION: ........................................................................................................................................................

ADDRESS: .....................................................................................................................................................................


TEL NO: .................................................................... FAX NO: ...................................................................................





should be sent to:

Finance Department



1 Nine Elms Lane,

London SW8 5NQ

United Kingdom

VAT No. GBGD 150








below.

Cheque Number:

APPENDIX 8



Guidance Notes on Applications for Clinical Trials

Exemptions and Clinical Trial Certificates

Price per copy £25.00 VAT at 0%* (includes first class mail / airmail within EC. For locations outside the EC

please add £10.00 for each copy.) For all export shipments please quote international airway bill.



NAME: ...........................................................................................................................................................................

ORGANISATION: ........................................................................................................................................................

ADDRESS: .....................................................................................................................................................................


TEL NO: .................................................................... FAX NO: ...................................................................................





should be sent to:

Finance Department



1 Nine Elms Lane,

London SW8 5NQ

United Kingdom

VAT No. GBGD 150








below.

Cheque Number:

APPENDIX 9


MCA ORGANISATIONAL STRUCTURE

AND CONTACT POINTS

THE policy of the Agency is to respond to all enquiries

promptly and courteously. For all normal enquiries, please

contact the person whose name is listed against the

subject of your enquiry. If you cannot obtain an answer,

or if you have reason to be dissatisfied, please contact

the Manager or Head of Division as appropriate.

Complaints Procedure

The MCA operates formal procedures for dealing with

complaints about the Agency’s administrative services

(not licensing and enforcement decisions) and our aim is

to respond to all written complaints within seven

working days. The procedures ensure that all complaints

are subject to a full and fair investigation, are handled

confidentially, receive a full response and are examined

for ways of improving our service provision in the future.

If you remain dissatisfied with the way your enquiry was

handled, having first contacted the head of the relevant

unit or Division, you are invited to write to Mr Michael

Gosling, Head of Corporate Services and MCA Central

Complaints Officer. If, following his reply, you remain

dissatisfied you will have access to the Independent

Complaints Advisor (ICA) who will also

fully investigate your complaint.

Separate procedures cover complaints made under the

Code of Practice on Access to Government Information

(the Code). If we cannot give you the information you

have asked for, or have to charge for that information,

we will explain the reasons why. If you are dissatisfied

with the MCA’s reply to your request, or the decision to

impose a charge, you can, as a first step, request a formal

internal review. A senior member of the Agency who

was not involved in the original decision will undertake

that review. If you remain dissatisfied, you can ask a

Member of Parliament to refer your complaint to the

Parliamentary Commissioner for Administration (the

Ombudsman) who may decide to conduct his own

investigation.

Direct dialling to all MCA staff is available by dialling

020-7273 before each extension number. If you do not

know whom to contact, please telephone our Central

Enquiry Point on 020-7273 0000.

Postal Address: Medicines Control Agency

Department of Health

Market Towers

1, Nine Elms Lane

London SW8 5NQ

Fax: 020-7273 0548

Chief Executive

Dr Keith Jones x 0100

Scientific Support Manager to the Directorate

Mr Shaun Delaney x 0695

Chief Executive’s Secretary

Ms Judith Thompson x 0546

DIRECTORATE

LICENSING DIVISION

CLINICAL TRIALS APPLICATIONS: CTC, CTX, DDX

ONLY

Fax: 020-7273 0443

Unit Manager

Dr Brian Davis x 0487

Secretary

Vacancy x 0456

General enquiries

Mrs Salma Syed x 0327

Preclinical enquiries

Mr Tim Berridge x 0391

Pharmaceutical enquiries

Dr Elaine Godfrey x 0463

Medical enquiries

Dr Brian Davis x 0487

Fax: 020-7273-0493

Acting Director of Division

Dr Alex Nicholson x 0200

Secretary

Mrs Ingrid Calvert x 0483

LICENSING GROUP I

Fax: 020-7273 0196

Acting Group Manager

Dr Julia Dunne x 0380

Secretary

Mrs Evelyn Russell x 0471

APPENDIX 10


EU ENQUIRIES

Mutual recognition applications (NCE products)

Professional aspects/strategy planning/updating of

dossiers and Expert Reports

Dr Julia Dunne x 0380

Dr Matthew Thatcher x 0635

Administrative issues

Mr Leslie Whitbread x 0451

Mrs Carole Stronell x 0454

Mutual recognition applications (abridged products)

Professional aspects/strategic planning/updating of


Mr David Hook x 0037

Dr Malcolm Summers x 0359


Dr Lincoln Tsang x 0465

Administrative support



Notification of need for Assessment Report prior to filing

in other Member States (for outgoing applications)



ASSESSMENT UNIT 4 (CHEMICAL ABRIDGED)

Fax: 0207-273 0190

Unit Manager


Secretary

Miss Wendy Wales x 0356

General and Pharmaceutical enquiries


Herbal Medicines (marketing authorisation enquiries)

Dr Linda Anderson x 0370

Prelinical enquiries

Mr Henry Stemplewski x 0388

Clinical enquiries

Dr David Woodings x 0148

COMMITTEE SUPPORT UNIT

Fax: 0207-273 0493

Unit Manager


Secretary

Miss Pauline McLeod x 0477

Administrative enquiries


ASSESSMENT UNIT 3 (CHEMICAL ABRIDGED)

Fax: 0207-273 0195

Unit Manager


Secretary

Ms Evelyne Doh x 0358




Dr Mahta Jahanshahi x 0297

Clinical enquiries

Dr Peter Feldschreiber x 0459

ASSESSMENT UNIT 2 (BIOLOGICAL AND

BIOTECHNOLOGICAL APPLICATIONS)

Fax: 0207-273 0062

Acting Unit Manager


Secretary

Miss Katrina Elder x 0221




Dr David Jones x 0469

Medical enquiries

Dr Frances Rotblat x 0440

BIOSTATISTICS UNIT

Unit Manager

Prof John Lewis x 0112

Secretary

Miss Susan Ramage x 0476

ASSESSMENT UNIT 1 (NEW CHEMICAL ENTITIES

AND ABRIDGED)

Fax: 0207-273 0170

Acting Unit Manager


Secretary

Miss Louise Cooper x 0472


Dr Andrew French x 0479


Dr David Snodin x 0438

Clinical enquiries


APPENDIX 10


PARALLEL IMPORTS, HOMOEOPATHICS, DRUG/

DEVICE UNIT

Acting Unit Manager

Mrs Elizabeth Baker x 0467

Parallel Imports

General Administrative enquiries

Mrs Renu Raizada x 0302


Mr Geoffrey Lay x 0375

Scientific enquiries

Dr Elizabeth Griffiths x 0298

Parallel Imports Renewals

Mrs Monika Clarke x 0322

Extension Directives (Radiopharmaceuticals)/Review


Homoeopathics

General Administrative enquiries




Scientific enquiries

Dr Elizabeth Griffiths x 0298

Advisory Board on the Registration of Homoeopathic

Products


Drug/Device Consultations


LICENSING GROUP 2

Parallel Imports, Homoeopathics, Drug/Device

Consultations, Extension Directives

(Radiopharmaceuticals) and Licensing Administrative

Support

Fax: 020-7273 0170

Acting Group Manager

Dr Siu Ping Lam x 0384

Secretary

Miss Meher Talati x 0484

Variations to mutual recognition authorisations

Administrative issues

Miss Anjali Vaidya x 0313

Professional aspects

Miss Shirley Norton x 0390

Dr Keith Pugh x 0427

Professional aspects (biological/biotechnological

products)


Written responses to Room 10-136, Market Towers for

the attention of Mrs. Stronell

Centralised Annex A applications and

Annex B applications for blood products under

Regulation 2309/93


Centralised Annex B applications under Regulation

2309/93 (including New Active Substance applications)


CSM – general questions (excluding adverse reactions)

Safety, Efficacy Sub Committee (administrative matters

only), appeals before the CSM (administrative matters

only)


Fax: 020-7273 0453

Biologicals Sub-Committee/CPS Sub Committee

(administrative matters only for both Sub Committees)


Mutual recognition applications (biological products)

Professional aspects/strategic planning/updating of



Administrative support



Notification of need for Assessment Report prior to filing

in other Member States (for outgoing applications)



APPENDIX 10


Pharmacopoeia Secretariat

see under INSPECTION AND ENFORCEMENT

POST-LICENSING DIVISION

Fax: 020-7 273 0675

Director of Division

Dr June Raine x 0400

Secretary

Ms Eugenie Elson x 0285

• Contact point for urgent drug safety matters

PHARMACOVIGILANCE

Group Manager

Dr Philip Harrison x 0113

Secretary

Ms Angela Phinn x 0276

Fax: 020-7273 0205

Specialist in Pharmacovigilance

Dr Patrick Waller x 0269

Secretary

Ms Doreen West x 0279

Fax: 020-7273 0205

Specialist in Pharmacovigilance Information systems

Mr Shaun Fiddes x 0708

Fax: 020-7273 0060

• Information on ADROIT

LICENSING ADMINISTRATIVE SUPPORT UNIT

REGISTRATION, DATA ENTRY, LICENCE

ISSUANCE AND GENERAL LICENSING POLICY &

ADMINISTRATIVE ENQUIRIES

Unit Manager

Mr Mike Heritage x 0365

General enquiries

Mr Rob Dyer x 0422

Drug Master Files enquiries

Mr Rob Dyer x 0422

Licence Issuance & Support

Mrs Keely Kennedy x 0314

Change of Ownership Application enquiries

Mrs Keely Kennedy x 0314

Registration enquiries

Mrs Jo Ellis 020-8398 9283

• Technical assistance for AEGIS subscribers and

AEGIS helpline (ADROIT Electronically Generated

Information System)

Information Manager

Mr Mick Foy x 0153

Fax: 020-7273 0060

• Reporting of ADRs by companies and provision of

information to companies

• Requests for ASPPs (Anonymised Single Patient

Print Outs)

• Special reporting Directive: Issues relating to the

Black triangle status of products

• Information on administrative procedures and

despatch of fortnightly ASPPs

• General pharmacovigilance enquiries

• Information and subscription details for AEGIS

Pharmacovigilance Assessment teams

National and Epidemiology team

Dr Peter Arlett x 0115

• Enquiries on drug safety assessment on national

authorisations

Mutual Recognition team

Dr Paul O’Mahony x 0257

• Enquiries on drug safety assessment on mutually

recognised authorisations

Centralised team

Dr Panos Tsintis x 0146

Fax: 020-7273 0205/0675

• Enquiries on drug safety assessment on

centralised authorisations

POST-LICENSING ASSESSMENT GROUP

Group Manager

Miss Shirley Norton x 0390

Secretary

Mrs Veronica Popo x 0648

Fax: 020-7273 0293

Variations Processing

Mr Robin Fraser x 0311/2/3

Fax: 020-7273 0310

• Variation tracking queries

Renewals Processing

Mrs Pratibha Madan x 0337

Fax: 020-7273 0124

• Renewals tracking queries

National Variation Team

Dr Keith Pugh x 0427

Fax: 020-7273 0293

• Variation enquiries

APPENDIX 10


Mutual Recognition Variation Team

Dr Richard Hart x 0399

Fax: 020-7273 0293


Centralised Variation Team

Dr Mark Caldwell x 0122

Fax: 020-7273 0293


Patient Safety and Renewals

Dr Nigel Baber x 0270

Fax: 020-7273 0293

• Renewals and reclassification enquiries

Mrs Amanda Williams x 0270

Fax: 020-7273 0293

• Advice on current legal classification/reclassifica-

tion applications

Mr Dugan Cummings x 0366

Fax: 020-7273 0293

• General enquiries about reclassification proce-

dures

Product Information and Advertising Team

Mrs Jan MacDonald x 0267

Fax: 020-7273 0293

• General enquiries on product information and

advertising

Mr Ian Park x 0149

• Product information application tracking queries

Mrs Aisha Dewangree x 0689

Fax: 020-7273 0109

• Advertising enquiries

INSPECTION AND ENFORCEMENT

Fax: 020-7273 0676

Head of Division

Dr Gordon Munro x 0500

Secretary

Ms Janet Rickards x 0577

INSPECTION GROUP

Group Manager

Mrs Linda Ambrose x 0580

Secretary

Vacancy x 0609

REGIONAL MANAGERS

North West Region

Mrs Elizabeth Allanson

Medicines Inspectorate

Chantry House

City Road

Chester CH1 3AQ

Tel: 01244-351515. Fax: 01244-319762

North East Region

Mr Bryan Wright


Prudential House

28/40 Blossom Street

York YO24 1GJ

Tel: 01904-610556. Fax: 01904-625430

Southern Region

Mr Paul Hargreaves


G23, 3 East Grinstead House

London Road

East Grinstead

West Sussex RH19 1RR

Tel: 01342-316184. Fax:01342-410676

Central Region

Ms Bronwyn Phillips


Crown House

Bridge Street

Hitchin

Herts SG5 2DG

Tel: 01462-435433. Fax 01462-421195

Biological Inspections

Dr Mike Kavanagh x 0576

Mr Paul Hargreaves x 0599

Head of GCP Inspections Compliance Unit

Vacancy, contact Group Manager x 0589 or inspector

GCP Inspectors

Mr David Cockburn 01904-673566

Mr Ian Oulsnam x 0702

Dr Anya Sookoo x 0722

Head of GLP Monitoring Authority

Dr Roger Alexander x 0590

GLP Inspectors

Mr Steve Monk x 0160

Mrs Mandy Flynn x 0154

Ms Scilla Cullen x 0155

APPENDIX 10


POLICY, BORDERLINE AND STANDARDS

Group Manager

Mr John Turner x 0589

Secretary

Miss Cheryl Bill-James x 0578

Policy and Borderline Unit Manager

Mr John Kneale x 0131

Pharmaceutical Advisor

Mrs Bernadette Sinclair-Jenkins x 0215

Policy Advisors

Ms Keely Duddy x 0442

Mr David Olszowka x 0573

Borderline Section Manager

Mr David Carter x 0613

Borderline Classifiers

Mr Simon Parker x 0612

Miss Jane Cole x 0602 (Mon-Thurs)

Quality Systems

Mr John Taylor x 0461

LABORATORIES & LICENSING

Group Manager

Dr Ged Lee x 0568

Secretary

Mrs Marine Cumberbatch x 0582

Defective Medicines Report Centre

Tel: 020-7273 0574 (weekdays 9.00 - 17.00)

Tel: 020-7210 3000/5371 (other times)

Pharmaceutical Enquiries

Mr Nigel Goulding x 0608

Laboratory (Canons Park)

Tel: 020-7972 2000. Fax: 020-8951 3069

Head of Canons Park Laboratory

Dr Amirul Islam x 020-7972 1030

BP Chemical Reference Substances

Mr Richard Turner x 020-7972 1032

Licensing and Exports Unit Manager

Mr Chris Brown x 0601

Manufacturer’s & Wholesale Dealer’s Licences

Section Manager - Mrs Caroline Beaumont x 0570

General Enquiries - Mr David Kwokori x 0585

Export Certificates and Import Notifications

Section Manager - Mrs Geraldine Richter x 0605

Export Certificates - Mr Andrew Graham x 0593

Import Notifications - Mr Colin Atkinson x 0593

ENFORCEMENT GROUP

Chief Enforcement Officer

Mr Norman Greenaway x 0607

Secretary

Mrs Marine Cumberbatch x 0582

Senior Investigation Officer

Licensed Medicines

Mr Bob Gillespie x 0175

Senior Investigation Officer

Unlicensed Medicines

Ms Anne Greaves x 0618

Intelligence Unit

Senior Analyst

Vacancy x 0203

Enforcement enquiries x 0025

Pharmacopoeia Secretariat

(for Laboratory (Canons Park) - see above

under Laboratories and Licensing)

Fax: 020-7273 0566

Group Manager:

Dr Robin Hutton x 0559

Biologicals/blood products/immunological

products

BP (Vet) - General

General Monographs

Labelling/Storage

Preservation/Sterilisation

Miss Marie Rabouhans x 0560

Inorganic Substances

Organic Substances

Radiopharmaceutical Preparations

Vegetable Drugs

Mrs Hillary Judd x 0558

Information Technology

Nomenclature BAN/INN

Organic Substances

Mr Roger Trigg x 0557

Organic Substances

New Monographs

Dr Patience Holland x 0555

APPENDIX 10


FINANCE DIVISION

Fax: 020-7273 0528

Director and Chief Operating Officer

Mr Graham Savage x 0700

Secretary

Mrs Sam Delahay x 0315

FINANCE

Financial Accountant

Mr Earnest Snow x 0711

Management Accountant

Ms Audrey Cahill x 0527

Systems Accountant

Ms Geraldine Burke x 0524

Sales Ledger Supervisor:

Mrs Mariam Khodabacksh x 0530

Company names

A to CP Mr Keith Wood x 0236

CQ to HM Miss Bushra Ali x 0532

HN to NE Miss Nicky Malik x 0533

NF to SE Mr Karl Faherty x 0511

SF to Z Miss Rica Tailor x 0531

EXECUTIVE SUPPORT

Fax: 020-7273 0353

Director of Division

Mr Roy Alder x 0600

Secretary

Ms Delphine Baccas x 0544

Fax: 020-7273 0737

CORPORATE SERVICES

Head

Mr Mike Gosling x 0514

Secretary

Miss Sandra Bryan x 0654

Personnel

Head

Mr Simon Fuchs x 0649

Fax: 020-7273 0522

Facilities and estates

Mr Ewan Robinson x 0639

Fees Policy

Mrs Sue Jones x 0652

INFORMATION CENTRE

Enquiry Point x 0000

Fax: 020-7273 0353

E-mail: [email protected]

Medical Information

Mrs Diane Leakey x 0678

EuroDirect Publications Service

Ms Tania Pereira x 0352

General Methods

Reagents

Mr Richard Middleton x 0556

Antibiotics

Dr Fiona Swanson x 0567

European Pharmacopoeia - general

Surgical Dressings/Sutures

Mrs Matilda Vallender x 0562

BP Chemical Reference Substances

(see Laboratory (Canons Park) - under Laboratories

and Licensing)

MEDICINES COMMISSION SECRETARIAT

Secretary

Mrs Sue Jones x 0652

Deputy Secretary

Mrs Judith Thompson x 0216

EUROPEAN SUPPORT, POLICY

COORDINATION AND DIRECTORATE

Group Manager

Miss Margaret Jackman x 0406

European Support

Unit Manager

Mrs Chris Bantock x 0395

Medicines Act Part III, Policy Co-ordination

Ms Angela Field x 0394

POLICY ON UNLICENSED HERBAL MEDICINES

Group Manager

Mr Richard Woodfield x 0068

LEGAL & LITIGATION COORDINATION

Miss Ruth Hobson x 0132

APPENDIX 10


Fax: 020-7273 0041

Manager

Dr Louise Wood x 0698

Secretary

Ms Juli Arthurs x 0206

Strategy Manager

Mr A Black x 0636

Special Projects Co-ordinator

Dr C Martinez x 0458

Business Development Manager

Ms L Morrison x 0633

Operations Manager

Dr Debbie Barbour x 0656

GENERAL PRACTICE RESEARCH

DATABASE

INFORMATION DIVISION

Fax: 020-7273 0140

Head of Division

Miss Doreen Hepburn x 0410

Secretary

Ms Janice Herod x 0409

MANAGERS

PLUS

Dr David Wheeler x 0350

ADROIT

Mr Shaun Fiddes x 0708

IT Services and Support

Mr Chris Read x 0653

Information Management Strategy

Ms Frances Law x 0372

Divisional Enquiries to Ms Frances Law x 0372

Fax: 020-7273 0140

Purchase Ledger

Miss Denise Erdel x 0508

Cashier

Ms Mira Mendes x 0507

Ms Debbie Sargent x 0507

Mr Luke Eacott x 0507

APPENDIX 10

‘Risk & Benefit’

This video follows the progress of a new drug through the regulatory systems, showing the activities of

the MCA’s departments responsible for assessment, control and inspection and post-licensing evaluation

and explains the influence of the new European licensing systems. The video also explains the function

of company regulatory affairs departments and the professional training and information role of the

British Institute of Regulatory Affairs (BIRA). Cost: £30 + VAT.

Running time: 30 mins. Available in VHS, SECAM and US format.

To order copies of the videos, please complete the form at Appendix 6

‘Medicines Under Control’

This video provides a good introduction and insight to the work and structure of the Medicines Control

Agency and is highly recommended to complement ‘Risk and Benefit’. Cost: £30 + VAT.

Running time: 26 mins. Available in VHS, SECAM and US format.

These popular videos have now been available for several years

and contain some information which has been superceded. We

have therefore decided to offer the remainder at the special

price of £30 + VAT each.

*Videos*


Order for individual copies of MAIL

Price per issue £5.00. VAT 0%* (includes first class mail/airmail within EC. For locations outside theEC please add £2.00 for each subscription).Issue No of MAIL required (eg. 109).........................................................................................................................

You do not need to subscribe to MAIL if you are a marketing authorisation holder, manufacturer

of wholesale dealers licence holder, hospital, health authority, health association or body with

direct regulatory responsibility. CTC, CTX and DDX holders are eligible for free subscription

to MAIL, if requested.

MAIL Subscription Form


NAME: ...............................................................................................................................................................................

ORGANISATION: ............................................................................................................................................................

ADDRESS: .........................................................................................................................................................................

POSTCODE: .............................................................. COUNTRY: ................................................................................

TEL NO: ..................................................................... FAX NO: .....................................................................................

TOTAL COST OF ORDER £ ...........................................................................................................................................

SIGNED:..................................................................... DATE OF ORDER: ....................................................................


All orders, together with your payment,should be sent to:

The CashierMedicines Control AgencyRoom 21-138, Market Towers,1 Nine Elms Lane,London SW8 5NQUnited Kingdom

VAT No. GBGD 150

All prices are £STERLING. Payment canonly be made by cheque and MUST be in£STERLING and drawn on a UK bank.



To avoid delays in processing your order,please can you enter your cheque number inthe box below.

Cheque Number:

Total number of copies requested ......................... Total Cost £ ...........................................................

Total number of copies requested ......................... Total Cost £ ...........................................................

Name of Subscriber to be used for mailing purposes .............................................................................................Price per subscription £25.00 VAT at 0%* (includes first class mail/airmail within EC. For locationsoutside the EC please add £10.00 for each subscription).

Annual Subscription - 1 January 2000 - 31 December 2000

Documents

MAIL - GOV.UK · PDF fileMAIL 121 September/October 2000 2 MC A MCA NEWS The Committee on Safety of Medicines (CSM) and the MCA have updated the Yellow Card by