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Transcript of MAIL - GOV.UK · PDF fileMAIL 121 September/October 2000 2 MC A MCA NEWS The Committee on...
MAIL 121
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
3 MAIL 121 September/October 2000
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
MAIL 121 September/October 2000 4
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
5 MAIL 121 September/October 2000
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
MAIL 121 September/October 2000 6
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).
• 2887/99 Note for guidance on
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).
• 205/95 Note for guidance on
evaluation of anticancer products in man
(EWP).
• 602/95 Points to consider in the
assessment of an anti-HIV medicinal
product Rev. 2.
• 1719/00 Note for guidance on
medicinal gases: pharmaceutical
documentation (draft) (QWP).
The following documents were adopted:
• 1042/99 Note for guidance on
repeated dose toxicity (SWP).
• 2711/99 Note for guidance on clinical
investigation of medicinal products in
the paediatric population (ICH).
• 364/96 Note for guidance on
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).
• 2655/99 Points to consider on
pharmacokinetics and
pharmacodynamics in the
development of antibacterial
medicinal products (EWP).
• 1595/00 Note for guidance on
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).
• 482/99 Points to consider on
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.
7 MAIL 121 September/October 2000
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
MAIL 121 September/October 2000 8
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
9 MAIL 121 September/October 2000
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
MAIL 121 September/October 2000 10
APPENDIX 2
11 MAIL 121 September/October 2000
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
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MAIL 121 September/October 2000 12
Price per copy at 0% VAT* (includes first class mail/airmail within EC. For locations outside the EC please
add £2.00):
1-9 copies @ £10.00 per copy
10-99 copies @ £7.50 per copy
100+ copies @ £6.00 per copy
Total number of copies requested ....................... Total Cost £ ...........................................................
MCA PUBLICATION ORDER FORM
Good Laboratory Practice
The GLP Pocket-Book
All orders, together with your payment,
should be sent to:
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:
Medicines Control Agency
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
13 MAIL 121 September/October 2000
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).
Total number of subscriptions requested ...................................... Total Cost £ ...............................................
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).
Total number of subscriptions requested ...................................... Total Cost £ ...............................................
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 £ ...............................................
All orders, together with your payment,
should be sent to:
Finance Department
Medicines Control Agency
Room 21-145, Market Towers,
1 Nine Elms Lane,
London SW8 5NQ
United Kingdom
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:
Medicines Control Agency
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
VAT No. GBGD 150
APPENDIX 5
MAIL 121 September/October 2000 14
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
(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
Please allow 28 days for delivery from receipt of order, subject to availability.
All orders, together with your payment,
should be sent to:
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:
Medicines Control Agency
To avoid delays in processing your order, please
can you enter your cheque number in the box
below.
Cheque Number:
APPENDIX 6
15 MAIL 121 September/October 2000
MCA PUBLICATION ORDER FORM
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).
Total number of copies requested ....................... Total Cost £ ...........................................................
(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
All orders, together with your payment,
should be sent to:
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:
Medicines Control Agency
To avoid delays in processing your order, please
can you enter your cheque number in the box
below.
Cheque Number:
APPENDIX 7
MAIL 121 September/October 2000 16
MCA PUBLICATION ORDER FORM
Manufacturer’s Licences and
Wholesale Dealer’s Licences Registers
Manufacturer’s Licences Register
Price per copy £5.00 VAT at 0%* (includes first class mail/airmail within EC. For locations outside the EC
please add £2.00 for each).
Total number of copies requested ....................... Total Cost £ ...........................................................
Wholesale Dealer’s Licences Register
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).
Total number of copies requested ....................... Total Cost £ ...........................................................
(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
All orders, together with your payment,
should be sent to:
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:
Medicines Control Agency
To avoid delays in processing your order, please
can you enter your cheque number in the box
below.
Cheque Number:
APPENDIX 8
17 MAIL 121 September/October 2000
MCA PUBLICATION ORDER FORM
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.
Total number of copies requested ....................... Total Cost £ ...........................................................
(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
All orders, together with your payment,
should be sent to:
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:
Medicines Control Agency
To avoid delays in processing your order, please
can you enter your cheque number in the box
below.
Cheque Number:
APPENDIX 9
MAIL 121 September/October 2000 18
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
19 MAIL 121 September/October 2000
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
dossiers and Expert Reports
Mr David Hook x 0037
Dr Malcolm Summers x 0359
Dr Matthew Thatcher x 0635
Dr Lincoln Tsang x 0465
Administrative support
Mr Leslie Whitbread x 0451
Mrs Carole Stronell x 0454
Notification of need for Assessment Report prior to filing
in other Member States (for outgoing applications)
Mr Leslie Whitbread x 0451
Mrs Carole Stronell x 0454
ASSESSMENT UNIT 4 (CHEMICAL ABRIDGED)
Fax: 0207-273 0190
Unit Manager
Dr Malcolm Summers x 0359
Secretary
Miss Wendy Wales x 0356
General and Pharmaceutical enquiries
Dr Malcolm Summers x 0359
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
Mr Leslie Whitbread x 0451
Secretary
Miss Pauline McLeod x 0477
Administrative enquiries
Mr Leslie Whitbread x 0451
ASSESSMENT UNIT 3 (CHEMICAL ABRIDGED)
Fax: 0207-273 0195
Unit Manager
Mr David Hook x 0037
Secretary
Ms Evelyne Doh x 0358
General and Pharmaceutical enquiries
Mr David Hook x 0037
Preclinical enquiries
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
Dr Lincoln Tsang x 0465
Secretary
Miss Katrina Elder x 0221
General and Pharmaceutical enquiries
Dr Lincoln Tsang x 0465
Preclinical enquiries
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
Dr Matthew Thatcher x 0635
Secretary
Miss Louise Cooper x 0472
Pharmaceutical enquiries
Dr Andrew French x 0479
Preclinical enquiries
Dr David Snodin x 0438
Clinical enquiries
Dr Matthew Thatcher x 0635
APPENDIX 10
MAIL 121 September/October 2000 20
PARALLEL IMPORTS, HOMOEOPATHICS, DRUG/
DEVICE UNIT
Acting Unit Manager
Mrs Elizabeth Baker x 0467
Parallel Imports
General Administrative enquiries
Mrs Renu Raizada x 0302
Pharmaceutical enquiries
Mr Geoffrey Lay x 0375
Scientific enquiries
Dr Elizabeth Griffiths x 0298
Parallel Imports Renewals
Mrs Monika Clarke x 0322
Extension Directives (Radiopharmaceuticals)/Review
Mrs Monika Clarke x 0322
Homoeopathics
General Administrative enquiries
Mrs Monika Clarke x 0322
Pharmaceutical enquiries
Mrs Elizabeth Baker x 0467
Scientific enquiries
Dr Elizabeth Griffiths x 0298
Advisory Board on the Registration of Homoeopathic
Products
Mr Leslie Whitbread x 0451
Drug/Device Consultations
Mrs Elizabeth Baker x 0467
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)
Dr Lincoln Tsang x 0465
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
Dr Lincoln Tsang x 0465
Centralised Annex B applications under Regulation
2309/93 (including New Active Substance applications)
Dr Matthew Thatcher x 0635
CSM – general questions (excluding adverse reactions)
Safety, Efficacy Sub Committee (administrative matters
only), appeals before the CSM (administrative matters
only)
Mr Leslie Whitbread x 0451
Fax: 020-7273 0453
Biologicals Sub-Committee/CPS Sub Committee
(administrative matters only for both Sub Committees)
Mr Leslie Whitbread x 0451
Mutual recognition applications (biological products)
Professional aspects/strategic planning/updating of
dossiers and Expert Reports
Dr Lincoln Tsang x 0465
Administrative support
Mr Leslie Whitbread x 0451
Mrs Carole Stronell x 0454
Notification of need for Assessment Report prior to filing
in other Member States (for outgoing applications)
Mr Leslie Whitbread x 0451
Mrs Carole Stronell x 0454
APPENDIX 10
21 MAIL 121 September/October 2000
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
MAIL 121 September/October 2000 22
Mutual Recognition Variation Team
Dr Richard Hart x 0399
Fax: 020-7273 0293
• Variation enquiries
Centralised Variation Team
Dr Mark Caldwell x 0122
Fax: 020-7273 0293
• Variation enquiries
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
Medicines Inspectorate
Prudential House
28/40 Blossom Street
York YO24 1GJ
Tel: 01904-610556. Fax: 01904-625430
Southern Region
Mr Paul Hargreaves
Medicines Inspectorate
G23, 3 East Grinstead House
London Road
East Grinstead
West Sussex RH19 1RR
Tel: 01342-316184. Fax:01342-410676
Central Region
Ms Bronwyn Phillips
Medicines Inspectorate
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
23 MAIL 121 September/October 2000
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
MAIL 121 September/October 2000 24
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
25 MAIL 121 September/October 2000
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*
MAIL 121 September/October 2000 26
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