What are medicinal products?

Generic medicinal products are medicines that contain the same active ingredient as an already approved original medicine.
They work in exactly the same way but  have a different name and are usually cheaper.

For a medicinal product to be considered a generic medicinal product, it must:

• contain the same active ingredient in the same amount,
• have the same form (e.g. tablet, syrup, suppository),
• and have the same effect in the body as the original medicinal product.

The original product to which the generic productrefers to is called the originator.

How is a generic medicinal product approved?

A generic medicinal product may only be sold if:

• the original product has been approved in the EU for at least ten years,
• and the generic product has been shown in a special study to have the same effect as the original.

This study is called a bioequivalence study.

What is a bioequivalence study?

This study examines:

• whether the active ingredient in the generic product enters the bloodstream as quickly and in the same quantity as in the original product.

If the results show that the effect in the body is almost identical, the generic medicinal product is considered equivalent.
The study must meet certain requirements that apply throughout Europe.

Are there any differences between the original and the generic medicinal products?

Yes, but only in certain respects:

• Excipients (e.g. fillers or colourings) may differ if they do not affect the effect.
• The manufacturing process may be different.
• The form may differ – e.g. tablet instead of capsule.

Important:
The quality must be equally high for both. The generic drug must submit all documentation relating to its manufacture and quality – just like the original.

When can a generic medicinal product be sold?

A generic medicine is only approved if:

• the bioequivalence study is valid,
• the safety is as good as the original’s,
• the excipients and manufacturing have no influence on the effect,
• all legal requirements are met (e.g. package insert, packaging, information for doctors and patients).

Only then can the generic medicine be placed on the market.
This means that doctors and patients can be sure that approved generic drugs are reliable and safe.