What are OTC medicines? A comprehensive guide.

OTC medicines are easily accessible – they help us quickly manage common ailments such as headaches, colds, or stomach issues. Learn how OTC medicines differ from prescription drugs, dietary supplements, and herbal products.

Key Takeaways:

• OTC medicines are medicinal products available without a prescription, typically used for short-term and occasional treatment.
• OTC medicines are easily available in pharmacies; some can also be purchased in places such as drugstores, hypermarkets, grocery stores, herbal and medical stores, or gas stations.
• The Ministry of Health decides whether OTC medicines can be sold outside pharmacies.
• When a responsible entity wants to introduce an OTC medicinal product to the market, they must apply for approval from the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products.

OTC Medicines – Basic Information

OTC medicines are usually used for short-term and occasional treatment. Below, we explain what OTC medicines are and what the acronym OTC means.

OTC Medicines – Definition

An OTC medicine, according to European legislation, is a medicinal product available without a prescription, meaning it does not require a doctor’s prescription. OTC stands for “Over The Counter,” which translates to “without a prescription.”

Classification of Medicines by Availability

The Pharmaceutical Law Act distinguishes five categories of availability for medicinal products intended for human use:

• Medicines available without a prescription (OTC medicines);
• Medicines available by prescription (Rx medicines);
• Prescription medicines for restricted use (Rpz medicines);
• Prescription medicines containing narcotics or psychotropic substances (Rpw medicines);
• Medicines for use only in closed healthcare facilities (Lz medicines).

Characteristics of OTC Medicines

• OTC medicines are medicinal products available without a prescription, containing active substances that:
  • Have a very low risk of causing severe side effects;
  • Are considered safe;
  • Have been properly tested.

OTC medicines are an essential part of daily healthcare. They are easily accessible and provide quick relief for common ailments such as headaches, colds, or stomach problems.

Like prescription medicines, OTC medicines undergo testing and registration procedures.

Availability of Non-Prescription Medicines

OTC medicines are readily available in both physical and online pharmacies. Some OTC medicines can also be purchased in places such as drugstores, hypermarkets, grocery stores, herbal and medical stores, or even gas stations. The regulation of which OTC medicines can be sold outside pharmacies is determined by the Ministry of Health’s ordinance of December 21, 2021.

OTC Medicines – Safe Usage

OTC medicines used for short-term treatment are safe when patients follow the manufacturer’s recommendations. Each OTC medicine package includes a leaflet with information on how the medicine works, when, how, and in what doses it should be taken. It also outlines possible interactions and side effects.

Types of OTC Medicines

OTC medicines include cold medications, pain relievers, and anti-inflammatory drugs. A complete list of OTC medicines approved for sale in Poland can be found in the Central Register of Medicinal Products, maintained by the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products.

Comparison of OTC Medicines with Other Medicinal Products

OTC medicines differ from other medicinal products in terms of availability, legal regulations, and patient risk levels.

OTC Medicines vs. Prescription Medicines (Rx)

OTC medicines can be purchased in pharmacies, online stores, and supermarkets without a doctor’s prescription. Prescription medicines (Rx medicines) are available only with a prescription issued by a doctor.
OTC medicines are considered safe for patients without medical consultation if the manufacturer’s recommendations are followed. Rx medicines require a doctor’s supervision due to their stronger effects and/or potential side effects. They are used for more serious conditions requiring precise diagnosis.

OTC Medicines vs. Dietary Supplements

OTC medicines are designed to treat illnesses, while dietary supplements are food products intended to supplement the diet and maintain good health. Supplements are not subject to the same safety procedures as medicines and do not contain active ingredients with proven medicinal effects.

Want to know more? Check out our blog post on the differences between medicinal products and dietary supplements.

OTC Medicines vs. Herbal Products

OTC medicines contain active substances (synthetic or natural) with proven effectiveness in treating specific diseases. Herbal products rely on natural plant extracts, whose efficacy is not always backed by modern clinical research. OTC medicines must undergo rigorous registration and control processes before market introduction, while herbal products must meet specific safety and quality standards, similar to dietary supplements.

Read our article on types of medicinal products.

Legal Status of OTC Medicines

OTC medicines are strictly regulated by relevant authorities, such as the Office for Registration of Medicinal Products in Poland and the European Medicines Agency at the European level.

To introduce an OTC medicinal product to the market, an entity must apply for approval from the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products. Approval is based on the medicine’s efficacy, safety, usage, and active ingredient composition.

Manufacturers must meet legal, technical, and quality requirements, including GMP standards.

Summary

OTC medicines (non-prescription) undergo registration and testing procedures, just like prescription drugs. In Poland, the responsible registration authority is the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products. The Ministry of Health determines which OTC medicines can be sold outside pharmacies.

Frequently Asked Questions (FAQ)

What conditions must a manufacturer meet to start manufacturing OTC drugs?

To start manufacturing OTC drugs, a manufacturer must have the appropriate technical facilities and laboratories for production that meet GMP standards. The OTC drug must also be approved by the appropriate body, e.g. the Office for Registration of Medicinal Products in Poland.

What does the registration process for a new OTC drug look like?

When a given entity wants to introduce an OTC drug to the market, an appropriate application must be submitted to the office registering medicinal products. In Poland, the competent office for registration of medicinal products is the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products. The application must be accompanied by detailed documentation regarding the composition of the OTC drug, the method of production, as well as the results of clinical trials confirming the safety and effectiveness of the OTC drug.

Where can I find a full list of OTC drugs approved for marketing in Poland?

The full list of OTC drugs approved for sale in Poland can be found in the Central Register of Medicinal Products maintained by the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products.

Where can OTC drugs be sold?

OTC drugs can be purchased in pharmacies, both stationary and online. Those medicinal products that have been approved for non-pharmacy sale can also be distributed in places such as: drugstores, hypermarkets, grocery stores, herbal and medical stores or petrol stations.
Can every OTC drug be sold outside of a pharmacy?

Not every OTC drug can be sold outside of a pharmacy. Some OTC drugs that pose a higher risk to the patient (e.g. painkillers containing stronger active substances) can only be sold in pharmacies, even if they are available without a prescription.

BIBLIOGRAPHY

1. Zimmermann, A., Michalski, B. (2009). Categories of availability of medicinal products. Pharmacy Poland 65(6): 453-457
2. Pharmaceutical Law Act of 6 September 2001 (Journal of Laws 2008, No. 45, item 271).
3. Regulation of the Minister of Health of 21 December 2021 on the list of active substances included in medicinal products that may be admitted to circulation in non-pharmacy circulation facilities and pharmacy points, and the criteria for classifying these products into individual lists (Journal of Laws 2022, item 208)