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Over the Counter (OTC)

Over the Counter (OTC)

Those of you in the OTC sector will be aware that OTC medicines play a vital role in healthcare, as many common illnesses can be easily managed by patients themselves, benefitting both the patient and the national economies.

It is worth noting that:

One out of two packages of medicines sold in Europe is a non-prescription medicinal product.

Source: Association of the European Self-Medication Industry web site

CambReg offers full regulatory support for OTC medicines

  • Preparation of MAA including OTC specific Labelling
  • User Testing of Patient Leaflet and Labelling
  • Handling of the registration procedure of your choice
  • Compliance with advertising codes of practice
  • Search for EU partners for pan European coverage if required
  • Reclassification from RX to OTC

Non-prescription medicines are those that:

  • Do not present a danger when used correctly, if utilized without medical supervision.
  • Even if used incorrectly they do not present a danger to human health
  • Do not contain substances for which the activity or adverse drug reactions do not require further investigation

Regulatory Procedures

Marketing Authorisation can be obtained for an OTC product using a National, Mutual Recognition or Decentralised Procedure

Annual statistics for the years pre-dating 2011 show that MRP/DCP were significantly underutilised by the self-medication sector. However, MRP/DCP can be an important regulatory route for Non-Prescription medicines as long as it is recognised that:

  • Classification of a medicinal product remains a national competence;
  • Different healthcare systems exist in Member States (MSs);
  • Procedures for determining the classification of a medicinal product differ between MSs – e.g. classification can be product based or substance based;
  • Product names of Non-Prescription medicines may differ between MSs;
  • Arrangements for access to Non-Prescription medicines differ between MSs.


Advertising and Labelling

As a healthcare professional is not necessarily involved in the recommendation of a non-prescription medicine, advertising directly to the public of the availability of non-prescription medicines is essential and makes an important contribution to public health. Monitoring of direct to consumer advertising is taken care of by the AESPG at a European level and at a national level for products that are not available EU wide

EU legislation allows advertising and limits the conditions under which Member States may impose restrictions on the advertising of non-prescription products (Directive 2001/83/EC, Article 88). Different countries have also moved from primarily government-led systems controlling the advertising of non-prescription medicines to a self-regulatory control environment. Self-regulatory bodies may control advertising before or after it is published or released.

The adoption of a self-regulatory approach has proven to improve the quality of the control while at the same time reducing a costly administrative burden for governments.


In the UK it is the PAGB that governs direct to consumer advertising:

PAGB operates a pre-publication approval system for member companies’ consumer advertising. It is a condition of membership that all advertising aimed at consumers must be submitted to PAGB for screening and PAGB approval has been given prior to its release into the public domain.

In addihe PAGB codes and guidance below, the Medicines and Healthcare products Regulatory Agency, MHRA, also provides detailed guidance on:

  • Advertising and promoting medicines: Blue Guide: advertising and promotion of medicines in the UK
  • Packaging: ‘how to package medicines for sale and what information you must provide to consumers and healthcare professionals’

More Information can be found at pagb.co.uk

If you require further advice in this area CambReg can help


Most medicines start life as Prescription only Medicines and when sufficient safety data has been accumulated that company can apply to ‘switch’ the legal status. Those companies that are looking to carry out a reclassification please follow this link Add Link to Reclassification web page

Products for self-medication may differ from country to country as legal status is dealt with at a National level. Most EU Member States have two categories Prescription and Non Prescription in a minority of Member States there is a third legal status category General Sale exist (as in the UK). For this category no intervention from the Pharmacist is required and the products can be sold in other non-pharmacy retail outlets

Europe – List of Non Prescription Medicines

A comprehensive list of drug substances and their legal status (Rx / Non Prescription) in each Member State can be found on the Association of the European Self-Medication Industry (AESPG) web site

This reference is good starting point when considering marketing an OTC product across the EU. CambReg can help with your registration strategy for such a project

For more information or an estimate, contact us »

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