Supplying authorised medicines to Northern Ireland

Supply of authorised medicines to Northern IrelandOverview

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Licensing requirements for medicines containing controlled drugs

There will be no changes to licensing requirements for medicines containing controlled drugs. This is covered by UK legislation.

Controlled drugs are controlled in the UK under the Misuse of Drugs Act 1971 (‘the 1971 Act’), the Misuse of Drugs Regulations 2001 (‘the 2001 Regulations’), and the Misuse of Drugs Regulations (Northern Ireland) 2002.

Home Office controlled drug import-export licensing requirements for trade in controlled drugs within the UK will not change.

Home Office controlled drug import-export licensing requirements for trade in controlled drugs from the UK, including from Northern Ireland, to the EU, and vice versa, will not change.

See the the list of the controlled drugs most enquired about. The list is not exhaustive and, in the event of a substance not being listed, youreference should also referbe made to the 1971 Act and the 2001/2002 Regulations at legislation.gov.uk.

There are no new licensing requirements under the 1971 Act for companies moving medicines containing controlled drugs from Great Britain to Northern Ireland as a result of the Protocol.

See guidance on on how to apply for a Home Office controlled drug import-export licence for for trade in controlled drugs from the UK.

ThereMedicinal areproducts issuescontaining regarding ephedrine and pseudoephedrine containing medicinal products which fall within the definition of ‘Category 4’ drugDrug precursorPrecursor chemicals.Chemicals. TradeAs such, trade between GB and NI will be subject to licensing in accordance with the requirements in precursorPrecursor chemical export and import authorisation. See Home Office guidance on precursor chemical licensing.

Contact

For further information, email our Customer Services Centre at info@mhra.gov.uk or call 020 3080 6000. Alternatively, contact your trade association.