1.What are generic medicines?
Generic medicines are the therapeutic equivalent of pharmaceutical products whose certificates expired. The generic medicines contain the identical active substances with the original ones, being used to treat the same conditions as the original products.
2.Are the generic medicines different from the original ones?
Generic medicines contain the same active substances as the original products. Considering the dose, concentration, administration means, safety, efficiency and therapeutic indications, they are equivalent to the original ones.
3.Who verifies the quality, safety and efficiency of a generic medicine?
In order to obtain the marketing approval, pharmaceutical companies need to prove that international criteria on quality, safety and efficiency of medicines are met. Al sites of the manufacturing medicine are audited and certified with quality norms Good Manufacturing Practices (GMP) by the National Agency of Medicine and of Medical devices (ANMDM).
4.Are the generic medicines as good as the original ones?
Yes, generic medicines are equally efficient as the original ones. They have identical dose, concentration, administration means, safety, efficiency and therapeutical indications.
5.Are the generic medicines cheaper than the original ones?
The prices for generic medicines are by 20%-80% lower than the original ones. In Romania, by Ministry of Health Order no. 75/2009, the price of a generic medicine cannot exceed 65% of the original medicine's price whose generic it is. The lower price of the generic medicines provides extensive and equal access to therapeutical first line solutions for all chronic diseases. In Europe, generic medicines play a primary role in providing sustainability and efficiency to health systems. It is estimated that the use of generic medicines leads to annual savings of over 30 billion Euros for patients and the health public budgets.
6.When a generic medicine can enter the market?
A company can develop a generic medicine, for the purpose of selling it, only after the certificates for the relevant original medicine expired.
7.For how long is a certificate for an original pharmaceutical product valid?
As in other industries, the standard certificate is valid for 20 years. In the specific case of the pharmaceutical industry, this term can be extended by up to five years through an Additional Protection Certificate.
8.Can a medicine have more than one certificate?
Yes, pharmaceutical products can have more than one certificate. In addition, one certificate for a new usage (â€śindicationâ€?) or formula can block the registration or market access for a generic medicine in case the primary certificate expired.
9.How long does it take to register a generic medicine in European Union?
Usually, registration for a generic medicine takes approximately 1-2 years but it can take longer. The generic medicine producers invest a lot of time and financial resources for product development. This process, occurring prior to the marketing of the product, can take more years. Moreover, in many EU member states, the market access of generic as well as original medicines is postponed due to the waiting period for price fixing and reimbursement level.
10.Do generic medicine companies have access to original product data?
No. Applications for generic medicine do not use data included in the registration file of the original product. Generic medicine producers cultivate their own research and development activity. Generic medicine developed by producers must then be approved in accordance to the same EU rules used for the original products.