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Code of Manufacturing Practice

Manufacturing Requirements

The Act required the Authority to issue a Code of Manufacturing Practice (the Code) relating to the manufacture of psychoactive substances. The Code came into force on 17 January 2014, six months after the commencement of the Act.

The Code outlines the quality control requirements for manufacturers of psychoactive substances.  The Code was structured into two documents; the technical requirements of the Code and the Implementation Plan (the Plan). All holders of interim licences to manufacture psychoactive substances were required to comply with the Code and meet the Plan’s staged timeframes. This staged implementation approach was designed to allow manufacturers sufficient time to develop the documentation that would allow them to move to a fully compliant Good Manufacturing Practice (GMP) environment, while providing more immediate assurances around the manufacturing process used during the interim transition period.

Implementation code cancelled

The Psychoactive Substances Regulations 2014 (the Regulations) which took effect 3 November 2014 signal the commencement of the full regulatory regime and closure of the transition period. To this end, the Implementation Plan of the Code has been cancelled.

With cancellation of the Plan, manufacturers will no longer be bound by the timeframes of the Plan. All manufacturers now wishing to apply for a full licence to manufacture will need to demonstrate compliance with GMP before being granted a licence.

Details of the requirements for GMP are described in the Code and manufacturers will be encouraged to progress towards full GMP.