Statutory Instruments

The Medicinal Products (Control of Manufacture) Regulations 2007

The main purpose of these Regulations is to implement TITLE IV of Directive 2001/83/EC (as amended by Directive 2004/27/EC) relating to the manufacture and importation of medicinal products for human use

The Regulations also implement Article 13 of Directive 2001/20/EC and Chapter 3 of Directive 2005/28/EC, which relate to the manufacture and import of investigational medicinal products. The Regulations also fully implement Commission Directive 2003/94/EC laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use

The Regulations also consolidate all the controls relating to the manufacture of medicinal products and investigational medicinal products into one set of Regulations

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