Non-prescription medicinal products

The marketing authorisation holder for a medicinal product can apply for a change of classification, for example from a prescription to a non-prescription medicinal product, or to sell non-prescription medicinal products over the counter in retail outlets other than pharmacies.

National or central authorisation

Decisions concerning classification are taken at national level except for centrally authorised medicinal products, where the decision is taken centrally and applies equally in all Member States.

However, decisions concerning the sale of medicinal products for human use over the counter in retail outlets other than pharmacies are always national.

How to apply for OTC status

The European Commission has published guidance to support applicants applying for OTC status for a medicinal product for humans. Applications for OTC status must fulfil the four criteria for prescription-only use which are described in the guidance.

The application must be accompanied by a cover letter in English. The Application must include:

• A clinical summary, including a critical analysis of the suitability and safety of the product with regard to self-medication. The proposed indication must be within the framework of the approved target population. If other similar products are authorised with non-prescription use, the proposed indication should be in accordance with the already approved. Any other proposed indication, dosage or packaging size must be specifically justified.
• A clear justification for the application must be provided for all products.
• Proposed package leaflet, label and mock-up. For certain substances there is an OTC substance report available to follow, for the substance and therapeutic area concerned.

Further information and guidance regarding applying for OTC status for medicinal products for human use is available in guidance from CMDh and the European Commission.

For medicinal products for animals OTC status may be granted if all conditions are met, in accordance with the regulation (EU) 2019/6, article 34.3.

Initial MA application

In the application form, indicate the legal status concerned for the application. Justification for OTC status for medicinal products for human use must be included in module 1.2 of the eCTD structure.

Timetable for change in classification

The evaluation time for change of classification and assessment to sell over the counter in retail outlets other than pharmacies is 120 days, with the possibility of ‘clock stop’.

Sales in retail outlets other than pharmacies

Description of certain products

The Swedish Medical Products Agency has reviewed the information provided in the package leaflet and the labelling on the packaging, as well as the packaging size and point of sale of certain selected pharmaceutical substances with many approved non-prescription medicinal products.

This review of up to now approved information for non-prescription medicinal products, is summarised in ‘OTC substance reports’, which are continually updated as new information becomes available. The information in these reports has also been standardised and, as far as possible, harmonised for substances in the same therapeutic field.

If there is an OTC substance report available to follow, when applying for OTC status, the OTC-information in the package leaflet and the labelling on the packaging should however also be kept within the framework of what is specified in the Summary of Product Characteristics.

OTC substance reports

Classification of medicinal products for human use are described in chapter 4 of Läkemedelslagen (2015:315) and in Läkemedelsverkets föreskrifter (HSLF-FS 2021:90) om godkännande för försäljning av humanläkemedel, chapter 6.

Classification of medicinal products for animals are described in regulation (EU) 2019/6, article 34.
Change in classification for medicinal products for animals are described in Läkemedelslagen (2015:315).