CMDh Best Practice Guide for authorisation of Non-Prescription Medicines in the Decentralised and Mutual Recognition Procedures CMDh/250/2012 Rev.2 happened in April 2022.
Main points of revision concerning pre-procedural phase (scientific and/or regulatory advice), validation phase, assessment of the classification (sharing of classification assessments, RMS role) and Annex 1 for reclassification from Prescription only to Non-prescription.
Scientific and/or regulatory advice in pre-procedural phase is now encouraged. It is explained, that to establish mutual interest in working together on an application and to facilitate a supportive role of the RMS, applicants are encouraged to get scientific and/or regulatory advice with the proposed RMS well in advance but at least six months prior to submission of an application that include novel non-prescription properties in order to discuss the regulatory strategy and the timing for the submission.
The applicant should submit in advance a comprehensive briefing document with specific questions to focus discussions and so that the NCA can ensure that assessors with the relevant knowledge and expertise are present at the meeting. It is valuable for the RMS to know the intention of the applicant regarding the classification of the specific medicinal product for which a MA is sought in all MSs concerned in the procedure at this stage of providing advice. Therefore, the applicant should present the situation in the respective CMSs in the briefing document if they are proposing a novel classification in one or several MSs.
For new DCP applications, where the acceptability of the prescription status in CMSs is uncertain and it is anticipated that the OTC and Prescription-Only SmPCs would differ, two parallel DCP procedures should be initiated with an aim to having a Prescription-Only outcome in one stream and an OTC outcome in the other. It is preferable, but not mandatory to keep both procedures with the same RMS. The CMSs to be added to each stream should be considered accordingly. For one product there can only be one set of common product information. Different strengths for a product can however have separate common product information.
A document should be submitted, which is separate from the clinical documentation, providing justification for Non-Prescription classification if the non-prescription classification is novel in any of the Member States concerned by the application, or the non-prescription properties of the product is extended, e.g. other indication or population (novel in this context is understood as new properties of a medicine regarding e.g. active substance, the therapeutic indication, the pharmaceutical form and the strength or the route of administration). This justification document is essential for assessing non-prescription legal status. Entitled, “Justification for Non-Prescription Classification” this document would be in module 1.2.
Validation phase – Classification should not be part of the validation process, as it is to be considered during the assessment phase. Therefore, validation of an application by a NCA should not be regarded as an agreement of the proposed classification which is a national issue.
Assessment of the classification of the medicinal product – anything affected by the proposed non-prescription classification, e.g. the product name and patient information, should be addressed as part of the initial dossier and made available at the beginning of the procedure. These are key parts of the assessment. In circumstances where the proposed classification is not accepted by a CMS due to a conflict with its national rules, the applicant can withdraw their application if they do not want the MA to be granted with a different classification to that proposed in their application.
New with sharing of classification assessments is that summary of the RMS preliminary or previous assessment (clearly stating that this is their national position) should preferably be included in the Overview (section Legal Status) of the Assessment Report.
RMS role is strengthen – Early discussion at CMDh could be initiated by the RMS if any clarification is required e.g. where a consensus cannot be reached by MSs involved in the procedure regarding details in the common product information necessary to obtain non-prescription classification in one or more MS. CMDh recognises that detailed discussion may be needed amongst NCAs concerned to reach consensus on indications (including population), posology and safety information that may enable Non-Prescription classification to be possible when this is considered in the national phase.
Annex 1 for reclassification from Prescription only to Non-prescription has some modifications. Firstly, giving more freedom to NCAs for providing information: details of national reclassification procedures may be found on each NCA’s website. “Justification for Non-Prescription Classification”, located module 1.2 of the eCTD, should be submitted. If it is established that it might be problematic to reclassify a product to Non-Prescription in the RMS and there is a realistic view to obtain non-prescription in at least 2 CMS, the applicant should consider starting a new MRP/DCP procedure for a Non-Prescription version of the product.
To ensure the NCA is best placed to discuss with the MAH the possibility of a successful procedure, the MAH is strongly recommended to prepare, for the advice meeting an overview of the classification of the product in all CMSs, including details of the differences between the SmPCs (Section 4.1, Section 4.2) and the relevant parts of the Package Leaflet (PL) in those MSs.
While there is no guarantee that the application for reclassification can be approved until full assessment of the application, the RMS is better placed to be supportive of the application if it has agreed the proposed Non-Prescription status in principle at the pre-submission/scientific advice meeting, and the MAH has submitted an application in accordance with current requirements of legislation and European guidelines.
Where the application is for a product that contains an active ingredient, which would be classified as non-prescription for the first time in the RMS or had previously been reclassified in the RMS, the RMS is encouraged to provide to all CMSs, their full preliminary or previous assessment of the change of classification or a summary of their preliminary or previous assessment of the proposal from the applicant for non-prescription classification, where available. A summary of the RMS preliminary or previous assessment (clearly stating that this is their national position) should preferably be included in the Overview (section Legal Status) of the Assessment Report.