Pharmaceutical industry: Legislation, guidance and policy

Pile of books with a gavel on topThis page provides links to information on medicines legislation, guidance and policy. It includes an overview of medicines legislation, including preparing a medicinal product for sale in the UK or EU marketplace, how the MHRA develops policy, the 'Sunset Clause' (statutory requirements to inform the Licemsing Authority of any disruptions in supply of medicines), and current MHRA consultations relevant to industry.

 

Overview of medicines legislation and guidance

Preparing a medicinal product for sale in the UK or EU marketplace

Herbal and homeopathic medicines

Inspection

Importing and exporting

Pharmacovigilance

Borderline products

Advanced therapy medicinal products

Glossary of legislation

he unwanted display of the text is removed here...dont delete this
 

Review of medicines legislation project

The unwanted display of the text is removed here...dont delete this
 

Review of unlicensed medicines project

The unwanted display of the text is removed here...dont delete this
 

Sunset Clause

The unwanted display of the text is removed here...dont delete this
  
 

 Better Regulation of Medicines Initiative (BROMI)

The unwanted display of the text is removed here...dont delete this
 

Ministerial Industry Strategy Group (MISG) New Technologies Advisory Panel

The unwanted display of the text is removed here...dont delete this
 

Developing policy

The unwanted display of the text is removed here...dont delete this
 

Current consultations

Public consultation (ARM 81): Request to reclassify Imodium Instants (loperamide hydrochloride) 12 tablet pack size from Pharmacy (P) to General Sales List (GSL) - the deadline for comments is 5 March 2012

Public Consultation (MLX 374): Transposition of Pharmacovigilance Directive 2010/84/EU - the deadline for comments is 28 February 2012

 

 

he unwanted display of the text is removed here...dont delete this


Page last modified: 10 February 2012