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Regulatory Affairs

 
 

Number 22
May 2007

Renewal of marketing authorisations
  for medicinal products intended for human use

Number 21
July 2006

• Application for pharmaceutical variations
  Specifically french characteristics 

Number 20
December 2005

Good pharmacovigilance practices

Number 19 
May 2005

• Pharmaceutical variation application

Number 18
May 2004

Orphan medicinal products

Number 17
September 2003

CTD Format
Module 3 – Quality

Number 16
March 2003

Directive 2001/83/EC of the European Parliament
  and of the Council
on the Community code relating
  to medicinal products for human use

Number 15
October 2002

Pharmaceutical variations related to a change
  in the composition of a product 

Number 14
May 2002

Packaging of medicinal products

Number 13
November 2001

Advertising of medicinal products to health-care
  professionals. Reasons for prohibition of
  advertising materials

Number 12
September 2001

"The role of Regulatory Affairs in the context
  of a change of manufacturing site" 

Number 11
March 2001

Review of ICH 5

Number 10
November 1999

The Summary of Product Characteristics

Number 9
February 1999

The pricing committee for medicinal products

Number 8
April 1998

Mutual recognition procedure

Number 7
November 1997

The European Pharmacopoeia

Number 6
June 1997

Advertising of medicinal products to
  health-care professionals

Number 5
February 1997

"Generics"

Number 4
September 1996

Medical devices

Number 3
May 1996

ICH: International Conference on Harmonisation

Number 2
March 1996

The European Agency for the Evaluation of
  Medicinal Products (EMEA). Consultative body
  of the European Union

Number 1
January 1996

ATU - French compassionate-use program
  (in French only)