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.

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).

Yes, generic medicines are equally efficient as the original ones. They have identical dose, concentration, administration means, safety, efficiency and therapeutical indications.

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.

A company can develop a generic medicine, for the purpose of selling it, only after the certificates for the relevant original medicine expired.

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.

Yes, pharmaceutical products can have more than one certificate. In addition, one certificate for a new usage (“indication”) or formula can block the registration or market access for a generic medicine in case the primary certificate expired.

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.

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.