Principles and Practice of Pharmaceutical Medicine

(Elle) #1

Notice to applicants of the EU Commission – guideline
on the categorisation of new applications versus
variations applications Jan 2002 (currently under
revision to reflect the new regulations in force since
Oct 2003).
EMEA CPMP: post-authorisation guidance (Human
medicinal products), February 2004. Document
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‘Changing the legal classification in the United
Kingdom of a medicine for human use’ guidance
booklet, MCA 2002.
The Prescription Only Medicines (Human Use), Order
1997 (The POM Order).
The Medicines (Products other than Veterinary Drugs)
(General Sale List), Order 1984 (the GSL Order).
The Medicines (Pharmacy and General Sale –
Exemption) Order.
The Medicines (Sale or Supply) (Miscellaneous Provi-
sions) Regulations.
The Medicines Act 1968 (as amended).
MHRA document ‘generic’ overdose sections for
selected SmPCs, Feb 2004.
MHRA: Best practice guideline on labelling and
packaging of medicines. Guidance note no. 25, June
2003.
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the Medicines (Advertising) Regulations 1994 (as
amended): the Medicines (Advertising) Regulations
1994, SI No. 1932; the Medicines (Monitoring of
Advertising) Regulations 1994, SI No. 1933; the
Medicines for Human Use (Marketing Authorisa-
tions, etc.) Regulations 1994, SI No. 3144; The
Medicines (Advertising) Amendment Regulations
1996, SI No. 1552.
The Medicines (Advertising and Monitoring of
Advertising) Amendment Regulations 1999, SI
No. 267.
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COREC New Operational procedures for NHS RECs,
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tees.
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radiopharmaceuticals and use of sealed radioactive
sources, ARSAC Dec 1998.
The ionising Radiations Regulations 1999 SI no 3232
and the ionising radiation (medical exposure)
Regulations 2000.
Guide to Good Manufacturing Practice. The Orange
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Guidance for notified bodies. Devices, which incorpo-
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MHRA Guidance note no. 18, revised June 2003.
Supplementary remarks of the BfARM in addition to
the Joint Notification by BfARM, BgVV and PEI of
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CIOMS IV form for reporting of serious unexpected
suspected adverse drug reactions: http://www.cioms.ch.
ABPI Code of Practice 2003.
ABPI Guidelines, 4th edition, draft 2004 (MJ Boyce).
Prescription medicines code of practice authority, con-
stitution and procedure, operative from July 1, 2001.
Presentation notes from MHRA breakfast meeting,
Thursday, February 26, 2004.
EMEA web site: http://www.emea.eu.int
EuDRACT database homepage: http://eudract.emea.
eu.int
ICH web site: http://www.ich.org
BfArm web site: http://www.bfarm.de
Swissmedic web site: http://www.swissmedic.ch
MHRA web site: http://www.mhra.gov.uk
COREC web site: http://www.corec.org.uk
The ABPI web site: http://www.abpi.org.uk
EMEA. Procedure for European Guidelines and related
documents within the pharmaceutical legislative
framework. London. June 20, 2005. Doc. Ref.
EMEA/P/24143/2004.
European Commission. Detailed guidance on the
European clinical trials database (EuDRACT Data-
base). April 2003, and successor documents CT 5.1
Amendment describing the development of
EUDRACT-Lot 1 (May 1, 2004) and CT 5.2
EUDRACT core dataset.
European Commission Directive 2003/94/EC. Principles
and guidelines of good manufacturing practices in
respect of medicinal products for human use and
investigational medicinal products for human use.
European Commission Directive 2005/28/EC. Princi-
ples and detailed guidelines for good clinical prac-
tices as regards investigational medicinal products
for human use as well as the requirements for
authorization of the manufacturing or importation
of such products.
EMEA. Guidance for companies requesting scientific
advice and protocol assistance, June 2008. EMEA/
H/4260/01/Rev.2.
European Commission. Proposal for a guideline on the
definition of a potential serious risk to public health,
November 2005.
European Commission. Proceduresfor marketing author-
ization: Chapter 3. Community Referral, February 2004.

REFERENCES AND RESOURCES 485
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