Welcome to MHRA-GMDP

The MHRA-GMDP database contains the following information issued by the MHRA relating to manufacturing and wholesale authorisations and certificates.

• Manufacturing and Import authorisations

  Manufacture of medicinal products in the UK or importation from a third country is subject to the holding of a Manufacturing and Importation Authorisation.

• Good Manufacturing Practice (GMP) certificates

  A certificate of Good Manufacturing Practice (GMP) is issued to a manufacturer if the outcome of the inspection confirms that the manufacturer complies with the principles of Good Manufacturing Practice.

• Statements of non-compliance with GMP

  If the outcome of the inspection is that the manufacturer does not comply, a statement of non-compliance may be issued and entered into MHRA-GMDP.

• Wholesale Distribution Authorisations

  The wholesale distribution of medicinal products and importation of medicines certified by a Qualified Person in accordance with Article 51 of Directive 2001/83/EC from listed countries is subject to the holding of a Wholesale Distribution Authorisation.

• Good Distribution Practice Certificates (GDP)

  A certificate of Good Distribution Practice (GDP) is issued to a wholesale distributor if the outcome of the inspection confirms that the wholesale distributor complies with Good Distribution Practice.

• Registration of manufacturers, importers and distributors of active substances for human use located in the UK

  Manufacturers, importers and distributors of active substances are required to register their activities with the MHRA. Since inspections of manufacturers of active substances are based on risk, some active substance manufacturers may not be in possession of a GMP certificate. The absence of a GMP certificate should not be understood as meaning that the active substance manufacturer in question does not comply with GMP.