Classification switching

In the UK the Medicines Act 1968 and Council Directive 2001/83/EC control the sale and supply of medicines. The legal status of medicinal products is part of the marketing authorisation (MA) and products may be available:

  • Prescription Only Medicines (POMs)

  • without prescription, under the supervision of a pharmacist (P)

  • On general sale (GSL)

Requests for change of legal classification of medicines and associated policy matters are dealt with by the Vigilance and Risk Management of Medicines (VRMM) Division of the Medicines and Healthcare products Regulatory Agency (MHRA). Which makes decisions on legal classification for products granted through National, Mutual Recognition (MR) and Decentralised (DC) procedures. The European Commission (EC) makes decisions for products authorised through the Centralised Procedure. For products authorised through the Centralised Procedure, where necessary, the appropriate National Competent Authorities legal status and other national information will be confirmed on the outer packaging (in a ’Blue box’) as set out in Article 57 of Directive 2001/83/EC.

SEQ has significant knowledge and experience in legal status and reclassification in the EU, particularly in Ireland and the UK.

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