The Medicines and Medical Devices Agency of Serbia (ALIMS) is responsible for quality control of drugs and medical devices. In order to carry out these tasks, the National Control Laboratory was established in the agency, which performs:
A) Control of the quality of the drug before issuing a license for the drug and before putting the drug on the market, which includes:
- drug quality control in the process of issuing a drug license;if necessary.
- control of the quality of the drug in the process of changes and additions (variations), as well as the renewal of the license for the drug, if necessary,
- quality control of the first batch of the drug after the issuance of the license for the drug,
- quality control of each batch of medicine for vaccines, serums, toxins, allergenic medicines from blood and blood plasma.
B) Control of the quality of the drug after the issuance of the license for the drug and after the release of the drug into circulation, which includes:
- taking random samples – systematic control
solving the observed problem – emergency control
V) Quality control of magistral and galenic medicines
QUANTITY OF SAMPLES FOR MEDICINE QUALITY CONTROL
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NOTICE OF STANDARDS
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In order to ensure the circulation of only high-quality, safe and effective medicines on the domestic market, the National Control Laboratory controls the quality of medicines through laboratory testing or documentary control.
Documentary quality control of a drug is a procedure for assessing the certificate of analysis of a drug, issued by the manufacturer or an expert body for drug quality control of a country in the European Union or another country that has the same or similar requirements for issuing a drug license.
Documentary quality control of the drug includes the quality control of each imported batch of the drug from the European Union or another country that has the same or similar requirements for the issuance of a drug license as well as the quality control of each batch of imported drug, which does not have a drug license and for which ALIMS has issued an approval for import.
Laboratory quality control is the procedure of analytical testing of the drug, which is carried out according to analytical procedures accepted by ALIMS, according to the regulations of the European Pharmacopoeia, the national pharmacopoeia, other recognized pharmacopoeias, as well as proven methods of analysis.
Laboratory quality control of the drug includes: control of the first batch of the drug; special drug control; systematic control; extraordinary control; quality control of every imported batch of medicine that comes from countries outside the European Union, i.e. countries that do not have the same or similar requirements for issuing a drug license and control of magistral and galenic drugs.
Quality control is performed by highly educated experts of the National Control Laboratory who have undergone and are undergoing planned continuous training in accredited laboratories of EU countries.