POM to P reclassifications to get quicker
The reclassification of medicines is to become quicker following the launch of a new procedure and accompanying guideline "How to change the legal classification of a medicine in the UK", by the Medicines and Healthcare products Regulatory Agency (6 December 2012).
The guideline is for companies looking to have their product moved from the prescription-only medicine to the pharmacy medicine category, or from a pharmacy medicine to the general sales list.
It aims to cut the time from application to decision by three months. According to a statement from the MHRA, the new guidance will:
- Minimise the need for formal engagement during the assessment process by increasing engagement before submission, and encourage pre-application collaborative work with key stakeholders.
- Reduce the types of applications which would require engagement with stakeholders during the application process
- Minimise the occasions on which expert advice would be sought
- Make stakeholder engagement more focused and time limited
"Improving access to medicines is to be welcomed when it improves people’s long-term health and takes into account wider social and public health concerns. We know the MHRA appreciate the vast difference between a GSL and pharmacy-only medicine. As the medicines available for reclassification are potent we believe that the ability for the public to access independent expert advice from pharmacists prior to purchase would be essential to ensure patients make informed and safe decisions about treatment," said Neal Patel, the Royal Pharmaceutical Society’s head of corporate communications.
The Proprietary Association of Great Britain said it welcomed the new procedure to speed up the process of moving medicines from prescription-only to over-the-counter.
Citation: The Pharmaceutical Journal URI: 11113014
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