end of the trial, April 2003 (Brussels, ENTR/F2/BL D
(2003)).
EC Commission. Detailed guidance on the collection,
verification and presentation of adverse reaction
reports arising from clinical trials on medicinal
products for human use, April 2004, revision 1
(Brussels ENTR/CT3).
The Common Technical Document for the registration
of pharmaceuticals for human use: organisation of
common technical document (CPMP/ICH/2887/99)’
ICH M4 guideline.
ICH E6 Guideline for good clinical practice (CPMP/
ICH/135/95).
ICH Topic E2B (M). Clinical safety data management:
data elements for transmission of individual case
safety report.
ICH Topic E2C. Clinical safety data management:
periodic safety update reports for marketed drugs.
Council Regulation (EEC) No 2309/93, of July 22, 1993,
laying down Community procedures for the author-
isation and supervision of medicinal products for
human and veterinary use and establishing a Eur-
opean Agency for the Evaluation of Medicinal Pro-
ducts. Amended by Commission Regulation (EC) No
649/98 of March 23, 1998 amending the Annex to
Council Regulation (EEC) No 2309/93 (EMEA).
European Pharmacopoeia document ‘Standard Terms’,
January 2000.
Commission Regulation (EC) No 1084/2003 of 3 June
2003 concerning the examination of variations to the
terms of a marketing authorisation for medicinal
products for human use and veterinary medicinal
products granted by a competent authority of a
member state (mutual recognition variations).
Commission Regulation (EC) No 1085/2003 of 3 June
2003 concerning the examination of variations to the
terms of a marketing authorisation for medicinal pro-
ducts for human use and veterinary medicinal products
falling within the scope of Council Regulation (EEC)
No 2309/93 (centralised procedures variations).
Orphan designation. Regulation (EC) No 141/2000 and
No 847/2000, ENTR/6283/00.
Detailed guidance on the European clinical trial data-
base (EuDRACT database) ENTR/F2/BL D (2003).
Regulation 540/95 arrangements for reporting sus-
pected unexpected adverse reactions which are not
serious.
The European Commission. Notice to applicants, a
guideline on Summary of product characteristics,
December 1999 (included in the rules governing
medicinal products in the European Community
Vol. 2A and 2B).
Summary of product characteristics for benzodiaze-
pines as anxiolytics or hypnotics (Eudralex Vol.
III BC1A).
Summary of product characteristics for ACE inhibitors
(Eudralex Vol. III BC2A).
User leaflet for oral contraceptives (Eudralex Vol. III
BC3A).
Summary of product characteristics for antimicrobial
medicinal products (Eudralex Vol. III BC4A).
Summary of product characteristics for antibacterial
medicinal products (Eudralex Vol. III BC5A).
CPMP/108/99 SARG role and responsibilities.
SOP 2072/99 on scientific advice by the CPMP.
Council Regulation (EC) No 297/95, of February 10,
1995, on fees payable to the European Agency
for the Evaluation of Medicinal Products. Amended
by Council Regulation (EC) No 2743/98 of
14 December 1998 amending Regulation (EC) No
297/95 on fees payable to the European Agency for
the Evaluation of Medicinal Products. Council reg-
ulation 2743/98 (fees for scientific advice).
Notice to marketing authorisation holders – pharma-
covigilance guidelines no. PhVWP/108/99.
CPMP Note for Guidance on Electronic Exchange of
Pharmacovigilance Information for Human and
Veterinary Medicinal Products in the European
Union, August 1999.
CPMP Joint Pharmacovigilance plan for the Implemen-
tation of the ICH E2B M1 and M2 requirements
related to the electronic transmission of individual
case safety reports in the community.
Conduct of pharmacovigilance for medicinal products
authorised through the mutual recognition procedure
EMEA, June 1997.
Conduct of Pharmacovigilance for centrally authorised
products EMEA, April 1997.
CPMP SOP 986/96 Rev 1 (Trade mark review).
Commission Regulation (EC) No 847/2000 of April 27,
2000 laying down the provisions for implementation
of the criteria for designation of a medicinal product
as an orphan medicinal product and definitions of the
concepts ‘similar medicinal product’ and ‘clinical
superiority’.
Quick-Look Leaflet: ‘Orphan Medicinal Product Des-
ignation in the European Union’ (EMEA/COMP/
661801), updated Oct 2003.
CPMP note for guidance (CPMP/EWP/QWP/1401/98)
on the investigation of bioavailability and bioequi-
valence.
CPMP/3097/02. Guidance on the comparability of bio-
tech derived proteins as active substances in med-
icinal products.484 CH34 MEDICINES REGULATION IN THE EUROPEAN UNION