Self-medication drugs, new AIFA guidelines for no prescription drugs and OTCs
A new decree of the Italian Medicine Agency is in the process of being published in the Official Journal, laying down the “Adoption of the new guidelines on the definition and classification of self-medication drugs (OTCs) and other medicinal products not subject to prescription (SOPs), replacing the Memorandum Letter of the Ministry of Health no. 13 of 16 October 1997”.
The new guidelines specify the definition and classification of the self-medication drugs: these include the so-called OTCs (Over The Counter), and no prescription medicinal products, called SOPs. The procedures to apply for the OTC or SOP classification for supply are also clarified.
OTCs and SOPs, what’s the difference?
The guidelines start by outlining the difference between OTC and SOP medicines. For the former, a direct access by users is provided for: they can be purchased in pharmacies or other stores specified in the regulations (law 4 August 2006, no. 248), including the so-called “parafarmacie” (drugstores that cannot sell prescription drugs) and corners in supermarkets and trade centres. For SOPs, on the other hand, the intervention of a pharmacist is required. For this reason, they cannot be displayed, nor advertised.
The 6 classification criteria for OTCs and SOPs
In order to be classified as OTC or SOP, a medicine must meet well-established characteristics, that are stressed by the guidelines.
The first criterion is the COMPOSITION.
Self-medication drugs can only contain active substances or their combinations whose medical use is well-known, wide and with proven efficacy and safety, that can be evidenced by a 5-year period of effective marketing in at least one country of the European Economic Area, also for one of its analogs.
Another essential criterion are the THERAPEUTIC INDICATIONS.
Only medicines for the symptomatic treatment of mild and transitory disorders, that can be identified and solved by the patients without doctor’s intervention, can be classified as OTC or SOP. Therefore, therapeutic indications must reflect a possible use with no diagnosis, prescription and surveillance by a doctor. They can also be used for recurring but short-lasting disorders, and only exceptionally for prevention.
The ROUTE OF ADMINISTRATION is also important.
Parental administration and all routes requiring the intervention of a health professional are excluded.
The POSOLOGY of OTCs and SOPs should have a wide margin of safety.
This must be considered with reference to the dose per posology unit, maximum number of daily dosing, maximum daily dose, total number of doses per pack and duration of the treatment.
The DURATION of the treatment must be limited.
The guidelines provide for that this is clearly indicated in the posology but, in any case, use is allowed only for short periods of treatment.
Finally, a careful RISK evaluation is needed.
Risks can be linked to an erroneous interpretation of the symptoms, inappropriate treatment, overdose, abuse or addiction, interactions with other drugs, special conditions or clinical pictures, severe undesirable effects, or correct understanding of posology and methods of administration.
How to apply for the SOP/OTC classification for supply
The most important part of the guidelines is where the procedures to apply for the classification of a drug as OTC/SOP are specified.
The Agency has explained that this classification for supply can be requested concomitantly with the marketing authorisation application or after its authorisation. However, in the case of medicines authorised by national, mutual recognition or decentralised procedure, a national variation application as C.I.5.z. (“unforeseen variation”) is to be submitted. A type IB variation should be only submitted if this is a change regarding the alignment of the classification for supply to the authorisation of another analogous product; in all other cases the variation will be a type II.
The case of medicines authorised by centralised procedure is different; for these products, the submission of an application to change the classification for supply (from medicinal product subject to prescription to medicinal product not subject to prescription) must be submitted to the European Medicine Agency (EMA).
In the guidelines it is stressed that the change of the classification for supply to SOP or OTC medicinal product must be applied only for drugs that have no pack sizes reimbursed by the Italian National Health System.
If, to meet the criteria imposed by the guidelines, a change in the therapeutic indication and/or posology regime is required, the variation application shall refer to the whole strength associated with the pharmaceutical form of the product, and not to a single pack size, to be submitted as per Regulation (EC) N. 1234/2008. For medicinal products authorised nationally, this variation can be submitted concomitantly in separate applications to change the classification of supply and to change/delete a therapeutic indication and/or to change the posology regime, or by a grouping also including the change of the classification for supply. For drugs approved by DCP or MRP, the change in the classification for supply can be requested only after the approval of the change/deletion of the therapeutic indication and/or change of the posology regime by the Reference Member State (RMS).
What changes if there are analog products already classified as OTC/SOP?
Finally, the guidelines list the documentation required to apply for the OTC and SOP classification. The factor that can make the difference is the presence of any analog medicines, that is medicines with the same active substance, method of release and route of administration, strength, therapeutic indications, posology and pack size that are the same as the ones of the product for which the classification is to be applied.
If there are medicinal products already classified in Italy as SOP or OTC, it is sufficient to attach to the application any documentation required to demonstrate the existence of these products.
In case there are no analog products registered with a SOP/OTC classification for supply, the documentation provided for by the national legislation and the European guidelines must be integrated with all documents that can demonstrate the compliance with the criteria for the classification of medicines as SOP or OTC. If a change is applied for a classification for supply already authorised, the documentation must include a critical review with reference to the guideline criteria and pharmacovigilance data.
As for the product information (Summary of Product Characteristics, Package Leaflet and Labelling), these must be drafted according to the QRD templates, and should include any specific information for medicinal products not subject to prescription.
Previous Post
Next Post