Pharmacos 4; Directive 92/27/EC; Directive 91/
356/EEC; Directive 87/22/EEC; Directive 97/43/;
Directive 92/28/EC; Directive 89/105/EEC; Eur-
opean Patent Convention Part II; CPMP/ICH/
2887/99; ICH E6 Guideline for good clinical prac-
tice; ICH Topic E2B (M); ICH Topic E2C; Eur-
opean Pharmacopoeia document ‘Standard
Terms’; Regulation 540/95; Eudralex Vol. III
BC1A; Eudralex Vol. III BC2A; Eudralex Vol. III
BC3A; Eudralex Vol. III BC4A; Eudralex Vol. III
BC5A; CPMP/108/99; SOP 2072/99; Council
Regulation (EC) No 297/95; PhVWP/108/99;
CPMP Note for Guidance on Electronic Exchange;
CPMP Joint Pharmacovigilance plan; Conduct of
pharmacovigilance for medicinal products; Con-
duct of Pharmacovigilance for centrally authorised
products; CPMP SOP 986/96 Rev 1; Commission
Regulation (EC) No 847/2000; Quick-Look Leaf-
let; Notice to applicants of the EU Commission;
EMEA/H/19984/03/Rev 2; MCA 2002; The Pre-
scription Only Medicines; The Medicines (Pro-
ducts other than Veterinary Drugs) (General Sale
List); The Medicines (Pharmacy and General Sale -
Exemption) Order; The Medicines (Sale or Sup-
ply) (Miscellaneous Provisions) Regulations; The
Medicines Act 1968; Guidance note no. 25, June
2003; Promotion of Medicines in the UK; The
Medicines (Advertising and Monitoring of Adver-
tising) Amendment Regulations 1999; Department
of Health; Guidance note no. 26, June 2003;
COREC New Operational procedures for NHS
RECs; ARSAC Dec 1998; The ionising Radiations
Regulations 1999; The Orange Book, 1997; Gui-
dance for notified bodies; Supplementary remarks
of the BfARM; CIOMS IV form; ABPI Code of
Practice 2003; ABPI Guidelines, 4th edition, draft
2004 (MJ Boyce); Prescription medicines code of
practice authority; Presentation notes from MHRA
breakfast meeting; EMEA/P/24143/2004;
European Commission; EMEA/H/4260/01/Rev.2.486 CH34 MEDICINES REGULATION IN THE EUROPEAN UNION