In relation to the activities established by the Law on Medicines and Medical Devices (“Official Gazette of RS”, No. 30/2010), the following activities are performed at the National Centre for Information on Medicines and Medical Devices of the Medicines and Medical Devices Agency of Serbia (ALIMS):
Provision of information and suggestions for rational use of medicinal products and medical devices;
Disposal of reliable information on medicinal products is a prerequisite for implementation of rational use of medicinal products.
In the procedure of marketing authorization issuance, as an integral part of the marketing authorization, ALIMS approves the Summary of Product Characteristics (SmPC) and Patient Information Leaflet (PIL). SmPC is the basic information for health-care professionals on how to use a medicinal product in a safe and efficient manner. The Patient Information Leaflet (PIL), which contains information for the patient, is prepared in accordance with the SmPC content, in a form that is adapted for the patient. These two documents contain information about the medicinal product intended for the professional and general public, which are necessary for doctors who prescribe the medicinal product for approved indication in an appropriate dose and in order to assess the potential risks of treatment to the patient or patients, as well as to better understand the basic information about the medicinal product and its route of administration.
In addition to registration documentation, approved SmPCs and PILs, the basis for the provision of information on medicinal products is also a literature search.
Apart from information on a medicinal product pertaining to the approved indications, dosage of contraindication, adverse reactions and other information on medicinal products, which are an integral part of the SmPC, ALIMS also provides expert opinions on medicinal products regarding registration status of a medicinal product, status in relation to the documentation with which the medicinal product is registered (own research or bibliographic data), as well as on the existence of parallel medicinal products (medicinal products that have the same INN, expressed in the same pharmaceutical form, regardless of the dose).
The prices of marketed medicinal products in the Republic of Serbia are under state control, and are regulated more closely by the Decree on criteria for setting the prices of medicines (“Official Gazette of RS”, No. 87/10 and 41/11). In the process of setting the price of a medicinal product, according to the applicable regulations governing this field, the starting point is the status in relation to the type of documentation with which the marketing authorization was issued.
A reference medicinal product is a medicinal product for which the marketing authorization has been issued in the Republic of Serbia or in the European Union member states based on full documentation on a medicinal product quality, safety and efficiency in accordance with the current requirements.
A generic medicinal product is a medicinal product with the same qualitative and quantitative composition of active substances and the same pharmaceutical form as the reference medicinal product, and whose biological equivalence in relation to the reference medicinal product has been proven through suitable investigations of biological availability. Different salts, esters, ethers, isomers, mixtures of isomers, complexes and derivatives of active substances are considered to be the same active substances of a generic medicinal product, unless they significantly differ in their safety or efficiency. Different forms of oral medicinal products with immediate release are considered to have the same pharmaceutical form of the generic medicinal product.
An innovative medicinal product undergoes research and development the same as the original drug, therefore preclinical and clinical studies of manufacturers form a portion of the registration documentation. A medicinal product is considered to be a therapeutic innovation when covering the therapeutic indication for which there are no other alternatives, and shows the best results with absolute clinical significance.
An innovative medicinal product can be, as follows:
- Medicinal product with new INN;
- Medicinal product with a new indication of an existing original medicinal product;
- Medicinal product with a new route of administration of an existing original medicinal product;
- Medicinal product with a new pharmaceutical form of an existing original medicinal product;
- Medicinal product with a dosage method of an existing original medicinal product.
When forming an assessment of whether an innovative medicinal product provides an advantage in therapy, it is crucial to take into consideration the medicinal product’s efficiency and safety. It is necessary to have all the information required to explain the advantages as compared with medicinal products already in use regarding the new medicinal products with marketing authorization. It is necessary to compare the new treatment with the one that is being used and thus identify the advantage in treatment with new medicinal product.
The benefit/risk profile is based not only on the criteria for evaluation of safety and quality, but it is necessary to add a third vector – an economic assessment. It is important to compare the once determined benefit/risk ratio for a new medicinal product with other medicinal products already on the market in order to provide the best choice of therapy.