Medicines and Healthcare products Regulatory Agency (MHRA) has now issued a guideline aimed at companies considering applying to change the legal classification of a medicine.
The new rule will help the pharma industry to optimize submission of applications and thereby facilitate assessment and outcome at a faster pace. It aims to provide general advice on the procedures for changing the legal classification of a medicine, to help ensure a simple, speedy and transparent process wherever possible, according to the regulatory authority.
In the UK, the default legal classification of a medicine is pharmacy medicine (P). However new medicines, when first authorized, are usually restricted for use under medical supervision and made available only with a prescription. A medicine restricted in this way is classified as a Prescription Only Medicine (POM). If experience gained during use gives evidence to demonstrate that the medicine is safe for use without prescription control, reclassification as a non-prescription product may be undertaken, stated the regulator.
In some cases availability may be limited to supply under the supervision of a pharmacist as a ‘P’ medicine. However if access to professional advice is not required for safe use of the medicine, it may then be reclassified as a General Sale List (GSL) medicine to allow sale from a wider range of retail outlets on self selection. Following reclassification from POM to ‘P’ or ‘P’ to GSL, some products may be limited to specific indications with appropriate restrictions on strength, dose and pack size, the regulator stated.
The European guideline on ‘changing legal classification for supply of a medicinal product for human use’ was revised January 2006. Now the 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 MHRA.
The applicants are strongly encouraged to apply for Scientific Advice Meetings (SAMs) initially for preliminary advice and later as the application develops, to discuss queries and seek guidance and advice relating to a proposed reclassification, prior to submission. Guidance and advice from key experts is also strongly recommended prior to SAM.
The UK Licensing Authority makes decisions on legal classification for products granted through National, Mutual Recognition (MR) and Decentralized (DC) procedures. The European Commission (EC) makes decisions for products authorized through the centralized procedure. For products authorized through the centralized procedure, where necessary, the appropriate UK legal status will be confirmed in the ‘blue box’ information on the label.
Early analysis using this framework will allow applicants to evaluate potential risk minimization proposals which can then be discussed with MHRA. These could include proposals for reduced indications, pack sizes, target population and dose.
For a major reclassification application, the stage before submission is a key element of the procedure, during which the data requirements and content of the application will be established. An early stage SAM with MHRA is helpful to guide the pharma industry approach to develop the proposed reclassification. Issues for discussion would cover evidence required, additional studies, the Risk Management Plan (RMP) and potential for exclusivity. MHRA can also advise companies on the regulatory process and the timetable which might be followed including any expected public consultation time in any particular case. Applications to change legal classification of drugs can be submitted at any time during the year, according to the regulator.