Medicinal products

In the light of the legal regulations, the term “medicines” has been replaced by “medicinal products”, which reflects changes in the regulations concerning these substances. This change results from the introduction of new legal regulations in the European Union, which aimed to unify the terminology and adapt the regulations to modern standards. The basic regulation concerning medicinal products is Directive 2001/83/EC.

Medicinal products include a wide range of preparations, such as medicines, vaccines or biotechnological preparations, which aim to improve the health of patients and their quality of life. The change from the term “medicines” to “medicinal products” aims not only to expand the definition, covering various therapeutic forms, but also to adapt the regulations to increasingly diverse methods of treatment, such as gene therapy, cell therapy or biotechnological medicinal products.

What is a medicinal product?

The Pharmaceutical Law Act of 2001, through amendments, introduced new definitions and terms, replacing the previous ones. As a result of these changes, the term “medicinal product” was updated to “medicinal product”. So according to the new definition, medicinal products are substances or their combinations that have properties that allow them to be used to prevent diseases, treat diseases occurring in humans, administered for the purpose of making a diagnosis, restoring, improving or modifying the physiological functions of the body through pharmacological, immunological or metabolic action.

The most important features that distinguish medicinal products are:

• Therapeutic effect of the medicinal product – that is, the ability to affect the body in a way that leads to improving health, treating or alleviating the symptoms of the disease. This is the basic task of every drug – it improves the patient’s condition by affecting the disease mechanisms in the body.
• Pharmacological effect – medicinal products contain substances that have a specific mechanism of pharmacological action. These may be active substances that affect the body, such as painkillers, antibiotics, anti-inflammatory drugs or chemotherapeutic agents.
• Safety and effectiveness – before being allowed on the market, medicinal products must undergo clinical trials to confirm their safety and effectiveness in the intended use;
• assessment and approval by the relevant authorities (drug registration) – medicinal products must be registered and approved by the relevant regulatory institutions, which ensures their compliance with quality and safety standards.

It is worth emphasizing that medicinal products may have different mechanisms of action, and their use should always be consulted with a doctor to ensure appropriate and safe therapy.

Types of medicinal products

Medicinal products are divided into different categories depending on their purpose and form. The most important of them are:

• Prescription drugs – require consultation with a doctor and a prescription.
• OTC (Over-the-Counter) drugs – available without a prescription, used to treat less complicated ailments, such as headaches, colds, or infections.
• Vaccines – preparations used to prevent infectious diseases, often covered by the mandatory vaccination schedule.
• Biological preparations – including hormones, vaccines, enzymes, as well as immunosuppressive drugs and gene therapies.

The process of authorizing medicinal products for marketing

Before each medicinal product is released on the market, it must go through a marketing authorization process that ensures its safety, effectiveness and quality. In the European Union, this procedure is strictly regulated and supervised by the appropriate agencies and institutions.

Since 1995, the main institution responsible for the evaluation and approval of medicinal products in the European Union has been the European Medicines Agency (EMA). This agency evaluates medicines under the centralized procedure, which means that after obtaining a marketing authorization in one EU country, the medicine can be available throughout the Union. This system aims to simplify administrative processes and provide faster access to new medicines.
The basic legal regulations concerning medicinal products are:

• Directive 2001/83/EC – regulates the marketing authorization and supervision of medicinal products.
• Regulation (EC) No 726/2004 – establishes the rules for the centralized procedure for the evaluation of medicinal products by the EMA.

Safety and surveillance

The safety of medicinal products is a key element of their use in medicine. Once they have been authorised for sale, medicines continue to be monitored by the relevant authorities to detect any potential adverse side effects and respond to them appropriately. The European Union has a Pharmacovigilance system that allows for the collection, analysis and reporting of adverse drug reactions, both from patients and healthcare professionals. Thanks to this system, it is possible to quickly implement changes in the use of medicines, such as the withdrawal of a product batch, a change in the recommended dose or a modification of the information leaflet