Publication of List of Active Substances Suitable for Reclassification (Switching)
On Thursday July 17th 2014, the Health Products Regulatory Authority (HPRA) published a list of twelve active substances (or combinations of substances) contained in medicinal products (medicines) currently classified as prescription-only medicines (POM) for which it considers the method of sale and supply (MoSS) classification could be safely switched from POM to over the counter (OTC) (pharmacy sale not subject to medical prescription).
There are currently 34 medicinal products authorised in Ireland containing an active substance (or combination of substances) included on the list. In line with certain conditions these could be reclassified to be made available for supply through pharmacies without prescription.
The list is available here.
This is an important development in the HPRA’s role in assigning the MoSS for medicines. It is the first occasion on which the Authority has proactively invited the submission of reclassification applications. This proactive approach will ultimately increase the range of medicines that can be made available to Irish patients through pharmacies without prescription. Supply of the medicines in question will continue to be assisted by the interventional advice and healthcare support of a pharmacist. It is also consistent with current Irish healthcare policy which aims, where appropriate, to provide patients with increased access to healthcare at the lowest level of complexity and cost.
The criteria for inclusion on the list include inter alia an indication suitable to self-diagnosis and self-treatment (or where a pharmacist can appropriately identify the patient population and diagnose the indication), clear instructions for use, defined maximum dose and maximum daily dose, appropriate duration of use, an appropriate safety profile in terms of contraindications, special warnings, interactions, use in pregnancy/lactation, sedation, adverse effects and potential for overdose. It is considered that medicines containing substances on the list either meet these criteria currently or could meet these criteria following variation or amendment of their marketing authorisation (MA).
Expressions of Interest and Applications
The HPRA is requesting expressions of interest from MA Holders of their intention to apply to switch the MoSS of their medicines. Expressions of interest should be made by email to email@example.com by 31/8/2014 and should include the PA number and name of the medicine.
Following receipt of expressions of interest, the HPRA will engage with each MA Holder in order to determine an appropriate timeframe for submission of the relevant switching application and supporting documentation. Depending on demand, a slot system for submissions may be considered. Pre-submission scientific and procedural advice on individual applications will be available to all interested MA Holders, from the date of publication of the list, in the form of telecon, email correspondence and face-to-face meetings with HPRA.
For further information and requests for scientific or procedural advice relating to switching the legal classification of a particular medicine, please contact firstname.lastname@example.org.
Further information on the background to the HPRA’s development of this proactive approach and future developments in this area are outlined below.
Consultative Panel Review
In 2011 the Irish Medicines Board (IMB), now Health Products Regulatory Authority (HPRA), established a Consultative Panel on the Legal Classification of Medicines. The Panel was independently chaired and consisted of external representatives drawn from a wide range of interested stakeholders including patients, healthcare professionals, the Department of Health and relevant government agencies. The focus of the Panel was to review policies relating to the legal classification of human medicines and to develop recommendations to address current unmet needs in the availability of non-prescription medicines.
The Panel concluded its work in 2013 and made recommendations for IMB/HPRA to consider development of a proactive and transparent process to encourage applications for reclassification. The Panel also recommended more direct engagement between IMB/HPRA and the applicant, particularly during the pre-submission stage; this would facilitate clearer understanding of the requirements which have to be met to ensure a successful reclassification of the product and provide improved predictability with respect to the timeline for approval of an application and/or outcome.
The publication of this present list of active substances from which applications for reclassification are invited, represents the outcome of measures which have been undertaken by the HPRA to address the recommendations of the Panel.
The HPRA is continuing to review active substances which may be suitable for reclassification. Updates to the list and proactive invitation for further applications will be part of this process. The present focus involves reclassification of prescription medicines. This will be extended over time to include reclassification of medicines currently available for sale through pharmacies to make these available, where it is considered safe to do so, on general sale in retail outlets.