IFU, PL, SmPC – what is it about?
Abbreviations from the title of the article are an integral part of the drug dossier. For a common man, such concepts as “instruction for medical use (IFU)”, “leaflet (PL)” and “summary of product characteristics (SmPC)” are synonymous. However, for the regulatory affairs specialist, there is a significant difference between these concepts.
In order to understand the difference between IFU, PL and SmPC, it is necessary to refer to the definitions of these concepts. According to Decision # 78:
“Instruction for medical use (patient leaflet)” – a document approved by the authorized body of the Member State in accordance with the acts of the Union bodies, containing information for the consumer and accompanying the medicinal product in the package;
In this case, it is clear that IFU and PL are synonymous, but for the RA specialist this is not entirely true. The thing is that the concept of IFU, for example, when carrying out the procedure for bringing into compliance, is applicable only in the case of circulation of the medicinal product on the territory of the Russian Federation, and PL is provided if it is planned to circulate the medicinal product in several EAEU member countries or instead of the IFU on the territory of the Russian Federation.
At the RegLec 2022 conference, one of the experts of the Federal State Budgetary Institution “NTsESMP” of the Ministry of Health of Russia presented a very informative table on the necessary “instructions” as part of the procedure of brining into compliance:
“Summary of product characteristics” – a document approved by the authorized body of the Member State, in accordance with the acts of the Union bodies, containing information for medical workers on the safe and effective use of the medicinal product.
Clearly, the key difference between the concepts of the IFU (PL) and the SmPC lies in the “target audience”. If IFU (PL) are intended for the general consumer without a medical background, then the SmPC can only be used by healthcare professionals.
1. Materials of the SCIENTIFIC-PRACTICAL CONFERENCE “MODERN APPROACHES TO THE EXAMINATION AND REGISTRATION OF MEDICINES” REGLEK — 2022
Decision of the Council of the Eurasian Economic Commission dated 03.11.2016 No. 78 (ed. 23.12.2020) “On the Rules of Registration and Expertise of Medicines for Medical Use”