Risk Minimization Measures (RMM)

PharmExpert LLC supports marketing authorization holders on routine risk minimization measures (RMM). 

In line with the good pharmacovigilance practices company take these measures to reduce the risks with respective safety concerns of medicinal products.

• the summary of product characteristics;
• the labelling (e.g. on inner and outer carton);
• the package leaflet;
• the pack size(s);
• the legal status of the product.

Summary of Product Characteristics (SmPC) and Package Leaflet (PL)

The summary of product characteristics and the package leaflet are important tools for risk minimization measures. It is due to the fact that they constitute a controlled and standardized format for informing healthcare professionals and patients about the medicinal product.

Pack Size

Since every pack size is specifically authorized for a medicinal product, planning the number of “dosage units” within each pack and the range of pack sizes available can be considered a form of routine risk management activity.

Legal Status

Controlling the conditions under which a medicinal product may be available can reduce the risks associated with its use or misuse, accordingly.

Restricted Medical Prescription

In scope of RMM it is applicable to use the restricted medical prescription to control the one who may initiate treatment. Also, to prescribe the medicinal product and the conditions of the medicinal product usage.

Special Medical Prescription

Application of classification “Special medical prescription” to the medicinal products which contain:

• in a non-exempt quantity, a substance classified as a narcotic or a psychotropic substance;
• a substance which, by reason of its novelty or properties, belongs to the group envisaged in the second indent as a precautionary measure or;
• the medicinal product is likely, if incorrectly used, to present a substantial risk of medicinal abuse, to lead to addiction or be misused for illegal purposes.