FAQ

1.  What is a generic drug?

Generic drug is identical (bioequivalent) to an innovative drug, contains the same active substance, it is applied in the same indication, on the same administrating way, at the same dosage and the same form. It is equal in quality and safety to an innovative drug, and can be manufactured after the patent protection of innovative drug has expired.

2.  What is an original (innovative) drug?

Innovative drug most often is a drug that contains new active substance, for which manufacturer has compiled complete documentation with clear evidence on efficacy, quality, and safety, that are based on his own experimental data, that include preclinical and clinical studies (for example, Summamed®). Based on this documentation, regulatory authorities on market (in Croatia, Agency for medicinal products and medical devices) evaluates quality and value of the drug and issue approval for licensing and supply of the drug. An innovative/original drug is usually patent protected for a period of 20 years.

3.  Does the generic drug look the same as innovative drug?

Generic version of the drug can sometimes have different color or form that differs from innovative/original drug. Those differences do not have influence on drug efficacy. They are present only to differentiate one drug brand from another.

4.  Why is generic drug more cost effective than an innovative drug?

Generic drug manufacturers can typically afford to sell their generic drugs for a lower price than their innovative counterparts, because the initial basic and clinical trials do not have to be repeated, so the cost that manufacturer has is lower than cost of innovative production.

5.  How does a drug innovator protect its product?

When a developer of a new chemical entity believes it has a useful product, it may decide to apply for a patent, which if granted, will typically last for twenty years, depending on the jurisdiction in which its issued. This means that, among other rights, that the drug developer – the originator of the drug – has the sole right to obtain regulatory approval of, manufacture and market the drug, or license others to do so, during the life of the patent. Also, the brand name of an innovative drug is often protected as a trade mark and cannot be used by any other party. Developers often secure additional patents after the initial patent is issued, in order to prolong their period of exclusivity.

6.  Are generic drugs really as good as innovative drugs?

The main predisposition for the marketing approval of a generic drug is to be equivalent in quality and bioequivalent, which ensures same safety and efficacy standards as for innovative drugs. This means that, in accordance with regulatory requirements, generic drug has to have the same active substance in the same quantity as the original drug and the rate of absorption and the quantity of absorbed substance in blood should be similar to the original drug(the majority of the oral administered drugs have to be absorbed in blood before they reach their medical effect). If the regulatory agency (ALMP in Croatia) is satisfied with results of such evidence on quality of the drug and its bioequivalence, it approves such generic drug and it is considered that it will have the same efficacy and safety as innovative drug.

7.  What is bioequivalence?

Bioequivalence is a comparison study of original and generic drug. Bioequivalence means that two drugs that have the same active substance, have similar bioavailability when administered at the same molar dose; to the extent that basically the same effect, including efficacy and safety, can be expected.

8. What does CHC stand for?

CHC is the English acronym for Consumer Healthcare, a division that provides a broad range of over-the-counter (OTC) products. OTC products include OTC medicines, dietary supplements and medical devices.

9.  What are OTC-drugs?

OTC-drugs (Over The Counter) are drugs that are in free sale, without prescription. They are proved to be safe in self treatment and for them previous physicians recommendation is not needed. Drugs without prescription are from manufacturing till marketing tested on rigorous control and as all other drugs are safe for administration in quantity and dosage as recommended on original packaging.

10. What is the difference between non-prescription medicines and dietary supplements?

Dietary supplements, unlike medicines, are not intended to cure or treat any disease, but only contribute to good health maintenance. They are preparations made from concentrated sources of nutrients or other substances with a nutritional or physiological effect. Their purpose is to supplement the normal diet and maintain good health, and not to treat diseases
Dietary supplements are regulated by the Food Act and their quality control is focused primarily on the analysis of health or sanitary validity.

11. How long does it take from the idea to the product launch?

The time period varies depending on which product is in question. For example, in case of the development of generic medicines that are subject to the strictly defined regulatory rules, it is necessary to gather a lot of scientific data on quality, safety and efficacy of the medicine, and the registration procedures take a long time. So, in this case the process takes two to three years.
In case of medicinal products and dietary supplements, development and registration procedures are slightly shorter. Dietary supplements are often very safe substances that contribute to the health and the registration procedures are less demanding. In this case, it may take a year.

12. What are adverse reactions?

Adverse reaction is every harmful and unintended reaction on drug which occurs at authorised dosages used for the prophylaxis or treatment of disease in humans. If patient notice some adverse effect after drug administration, he should inform his physician, pharmacist or drug manufacturer. Every drug manufacturer has to have qualified person for adverse reactions and available contact for notification 24 hours per day, 7 days in week. They are obligated to report adverse reaction to National centre for adverse reactions. Sometimes because of the serious and common adverse effects a drug has to be withdrawn from the market.

13. How to store drugs?

Drugs should be stored in their original package with attached leaflet, so that you can be sure which drug it is, its usage and expiration date. Drugs should be stored on dry and dark place, on room temperature (if not different prescribed), and out of the reach of children. After finishing the prescribed therapy, leftovers of the unused drug should not be stored. One should be careful not to have drugs with expired dates in “pharmacy in house”, because they are inefficient and dangerous for health. At home should be stored only small quantities of basic, not prescribed drugs that could be used, for example analgetics, antacid drugs , pastilles for throat, antipyretics and for case of minor accidents antiseptic, gauze, bandage and patch.

14.  What should we do with drugs that have expired?

The drugs that have expired should not be put in domestic waste. The only safe way of disposing expired drugs is thermal treatment in specialized incineration plant , what is also a legal obligation. In Croatia there is organized collection of non-useful drugs by disposing in special containers that are placed in pharmacy stores and some clinics.