Guidelines for the Regulatory Assessment of Medicinal Products for Use in Self-Medication
(2000; 31 pages) View the PDF document
Table of Contents
Close this folder1. Introduction
View the document2.4 Characteristics of self-medication
Open this folder and view contents3. General basis for regulatory assessment
Open this folder and view contents4. Collection and regulatory assessment of evidence for medicinal products intended for self-medication
View the documentAnnex
View the documentAcknowledgements

1. Introduction

Self-care can be defined as the primary public health resource in the health care system. It consists of the health activities and health-related decision-making of individuals, families, friends, colleagues at work, and so on. It includes self-medication, non-drug self-treatment, social support in illness, and first aid in everyday life.

The reclassification of medicinal products from sale on prescription only to non-prescription (over-the-counter, or OTC) sale is of great current interest in many countries. Drug regulatory and health authorities have to consider the types of medicinal products for which reclassification is appropriate, safe and rational in the interest of public health.

It has become widely accepted that self-medication has an important place in the health care system. Recognition of the responsibility of individuals for their own health and awareness that professional care for minor ailments is often unnecessary have contributed to this view. Improvements in people’s general knowledge, level of education and socioeconomic status in many countries form a reasonable basis for successful self-medication. New drugs with specific pharmacological action, such as histamine H2-receptor antagonists, nonsteroidal anti-inflammatory compounds (NSAID) and nicotine preparations for cessation of smoking, have been successfully reclassified from prescription to non-prescription status in many countries. Regulatory assessment of a change from prescription to non-prescription status should be based on medical and scientific data on safety and efficacy of the compound and rationality in terms of public health.

The purpose of the present guidelines is to suggest criteria and methods which drug regulatory authorities can employ in determining the suitability of medicinal products for use in self-medication. The term “assessment” is used rather than “clinical evaluation”, since in many cases the process will involve a review of existing data and experience and not the performance of new clinical trials or investigations, though the latter may occasionally be necessary. The guidelines are also intended for use by marketing authorization holders applying for the classification of a prescription medicinal product to be changed to non-prescription sale. Lastly, they provide guidance on documentation for new active substances which have not been marketed as prescription medicines to accompany applications for marketing authorization in self-medication.

The initiative for the review of prescription products or any new product that might reasonably be released for self-medication has generally been taken by the pharmaceutical industry in the form of documented proposals to national drug regulatory authorities. Occasionally, such authorities have themselves taken steps to reclassify medicinal products to make them available for self-medication. In some cases, moreover, products have been changed back from self-medication to prescription drug status because new safety issues have arisen. This underlines the fact that it is of crucial importance carefully to monitor the use of medicinal products and post-marketing data on adverse effects to be able to respond adequately and quickly to possible harmful developments.


If a new chemical entity or a prescription product meets the three basic criteria, the following additional criteria may favour consideration of change of status to non-prescription sale:

(1) The use of the product has been sufficiently extensive or in high enough volume.

(2) The product has been marketed on prescription for at least five years. The time considered appropriate for a product to have been on prescription varies widely, e.g. no time specified in the European Union, three years in New Zealand, six years in Japan, and up to 10 years in the Philippines.

(3) Its adverse events give no cause for concern, and their frequency has not increased unduly during the marketing period.

The reason for requiring five years of prescription marketing is that withdrawals from the market because of adverse events or the need for major changes in product information have usually occurred during the first three to five years after the start of marketing in countries with effective systems of safety monitoring. A high level of use permits detection of relatively rare but serious adverse effects, and sometimes the detection of an increased frequency of particular adverse events. High use also is likely to mean that the drug has been used in a broad range of people with a wide variety of concomitant diseases, concomitant drugs and risk factors for adverse events. It should be noted that the period of use may vary in countries with well-developed pharmacovigilance systems.

The criteria outlined above are based on the normal stepwise widening of exposed patients in three consecutive stages of drug development:

(1) Investigational use prior to marketing authorization, with limited controlled exposure of a relatively small group of people in clinical trials who are monitored closely for adverse effects.

(2) Prescription marketing, entailing exposure of potentially large numbers of people, though limited to those who go to a physician and for whom the physician considers the drug has a positive benefit/risk balance in the treatment of a disease.

(3) Marketing and commercial promotion for self-medication - involving the increasing exposure of potentially enormous numbers of people - when concomitant diseases and other medications used may vary, and other risk factors such as pregnancy, lactation, working conditions (driving), sport, alcohol use, and potential interaction with climate, sun or food may be present. It should be noted that systems to monitor adverse reactions to self-medication products may not always exist.

Only for a few drugs will information from the clinical trials prior to use be enough to support general availability in self-medication form, because such trials are conducted in selected populations monitored intensively for efficacy and safety. However, experience from marketing elsewhere in the world may provide suitably detailed data on exposure under conditions of use that are sufficiently similar to the situation in a particular country. Additional clinical studies may sometimes be necessary in the target consumer population where the product is expected to be used.

It should be borne in mind that consumers may consider that a medicinal product not subject to a medical prescription is less harmful than the same product when subject to a medical prescription. In such cases, labelling directed to the consumer should clearly communicate both the benefits and the risks of using the product for self-medication.

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