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Liljana Ugrinova, Pharm. Spec.
Mob: (++ 389) 72 228 542

Aneta Dimitrovska, PhD, Full Professor

Majka Tereza 47,
PO Box 36,
1000 Skopje, R. Macedonia


In the activities of the Center for drug quality control (CDQC) are included: 11 analysts, 2 laboratory technicians, a hygienist, IT consultant and associates;

  1. Liljana Ugrinova,
  2. Aneta Dimitrovska,
  3. Suzana Trajkovikj Jolevska,
  4. Rumenka Petkovska,
  5. Ljubica Shuturkova,
  6. Zoran Kavrakovski,
  7. Vasil Karchev,
  8. Gjoshe Stefkov,
  9. Jelena Acevska,
  10. Katerina Brezovska,
  11. Natalija Nakov,
  12. Aleksandra Grozdanova,
  13. Ana Poceva Panovska,
  14. Jasmina Tonikj Ribarska,
  15. Svetlana Kulevanova,
  16. Marija Zafirova,
  17. Gabriela Petrovska-Dimitrievska,
  18. Liljana Atanasova,
  19. Marija Karapandzova,
  20. Slobodanka Fidanovska,
  21. Ljubica Bojcovska,
  22. Gordana Dimitrovska,
  23. Srgjan Cvetanovski.


The Center for Drug Quality Control is organized as an independent organizational unit with its own staff, working space and equipment, within the Faculty of Pharmacy, Skopje.

The Center is authorized by the Ministry of Health of R. Macedonia to control the quality of drugs, on the basis of Article 99, Paragraph 1 of the national Law on Medical Products and Medical Devices (Official Gazette of R. Macedonia No. 106/2007).

The CDQC has been accredited on national level, by the Accreditation Institute of the Republic of Macedonia since 2006 (Certificate for accreditation No. LT-003, from 17th November, 2006). Reaccreditations were received in 2010 and 2014. The maintenance of a Quality Management System was related to the implementation of the MKC EN ISO/IEC 17025 standard. The introduction of international quality standards in laboratory work enables international recognition of the CDQC which builds confidence in the issued test results.

The scope of accreditation of the Center includes a number of techniques and methods that fully carry out a physical and chemical examination of the parameters specified in the quality specification of the finished pharmaceutical products.

Since May 14, 2013, the Center for Drug Quality Control within the Faculty of Pharmacy – Skopje, has become a full member of the General European OMCL network (GEON), after successful Mutual Joint Audit by the European Directorate for Quality of Medicines (EDQM). The new received certificate is valid until March 2021. This enables our country to participate in the activities and work within this network of laboratories responsible for monitoring of the drug quality on in the European market and beyond.


The Center for Drug Quality Control has a total area of ​​~ 215 m2, which includes seven rooms: one sample room, four laboratories, a storage room for chemicals and glassware and a warehouse for documentation.

Our laboratories are designed in accordance with the standards for the implementation of the physical and chemical parameters: laboratory 1 and 2 (for physicochemical testing), laboratory 3 (for instrumental analyzes) and laboratory 4 (for liquid chromatography). The laboratories are equipped with state-of-the-art equipment for testing physical and chemical parameters for quality control of all pharmaceutical dosage forms:

  1. Five apparatus for high-pressure liquid chromatography (HPLC): Agilent HPLC/DAD 1100 series with Quaternary Pump; Agilent DAD/FLD 1200 series with Binary Pump and Rapid Resolution; Agilent DAD 1260 series with integrated cooling system; Shimadzu UHPLC/DAD/RID Nexera and Shimadzu UPLC/DAD-MS/MS Nexera;
  2. Shimadzu, AA-7000 Atomic Absorption Spectrophotometer;
  3. Agilent 8453 UV/VIS Spectrophotometer;
  4. Perkin Elmer, CLARUS 500 Gas Chromatograph and Headspace;
  5. Erweka DT 800 LH and SOTAX AT 7 smart (dissolution systems for pharmaceutical dosage forms) and Erweka ZT 72 (apparatus for disintegration of pharmaceutical dosage forms)
  6. Mettler Toledo, Karl Fischer Titrator;
  7. Mettler Toledo RM40 Refractometer and MCP 200 Polarimeter (Antor-Paar);
  8. Other laboratory equipment: two analytical scales (Sartorius, Mettler Toledo), pH meter/Conductometer/Ionometer (Mettler Toledo), WiFi data loggers for temperature for medical refrigerator, temperature control loggers, humidity meters, TLC chamber, centrifuge, ultrasonic baths, water baths, magnetic stirrers (with temperature controller and mixing speed), medical refrigerator and refrigerator (4°С, – 20°С), automatic pipettes, micropipettes and etc.


  1. The main activity of the Center for Drug Quality Control is to perform laboratory analysis of pharmaceutical products, as follows:
    • Laboratory (pharmaceutical-chemical and technological) testing of:Substances (active substances, excipients) and Finished products.
      The quality control of medicinal products, in accordance with Article 100 of the national Law on Medical Products and Medical Devices, refers to:
    • Regular quality control of all medicinal products placed on the market in the Republic of Macedonia (minimum once every five years);
    • Quality control of the first batch of the drug / parallel imported drug, before placing the drug on the market;
    • Quality control of each batch of drug / parallel imported drug;
    • Random quality control, quality assurance of pharmaceuticals carried out at the request of the Agency or during the procedure for obtaining a marketing authorisation or after issuing the authorisation;
      Laboratory testing before the clinical phase of the trial commences.
  1. Assessment and verification of Module 3
    The staff within the Center is appointed by the Macedonian Agency for Medicinal Products and Medical Devices in the assessment and verification of Module 3 of the documentation in the procedure for obtaining a marketing authorisation, renewal of the marketing authorisation for medicinal products as well as variations of the pharmaceutical documentation.
  2. Activities within the OMCL network
    Representatives from CDQC are actively involved in GEON as members of working groups, whose activity is related with the quality control of the active substance, medicines of suspicious quality and counterfeit medicines. They are participants in working groups for preparation of guidelines / quality management guides in laboratories, projects, and finally they take part in organized trainings / educational seminars in specialized areas.
    The CDQC continuously participates in inter-laboratory testing’s and collaborative studies to determine the quality of reference standards of the European Pharmacopoeia.
  3. Activities related to the fight against counterfeit medicines
    At national level, an anti-counterfeiting drug campaign has begun, in which the Macedonian Agency for Medicinal Products and Medical Devices runs a project entitled: “Building a national strategy for combating drug counterfeiting” where the project manager is Assoc. Prof. Katerina Brezovska, representative from the Center for Drug Quality Control.
  4. Participation in the work of the European Pharmacopoeia
    Considering that our country is a signatory state to the Convention for the Development of the European Pharmacopoeia in 1994, experts from CDQC are members of the Commission for the preparation of the European Pharmacopoeia monographs and other texts.
    The Center is conducting experimental work within the expert groups responsible for the elaboration of the European Pharmacopoeia monographs in order to revise and develop new analytical procedures envisaged in these monographs.
  5. Participation in legislative drafting
    Representatives of the Center are participating in the preparation and harmonization of the national Law on medicinal products and medical devices with the regulations of the European Union.
  6. Participation in educational purposes
    The Center is involved in the education process in postgraduate and specialist studies at the Faculty of Pharmacy in the area of Drug Quality Control, as well as in organizing seminars within the Center for Continuing Education.

The Center for Drug Quality Control receives financial income by charging the services in accordance with the Guideline for charging fees in accordance with the national Law on Medicinal Products and Medical Devices (Official Gazette of RM, No. 188 from 2nd November, 2015) and the adopted price list between the CDQC and the Macedonian Agency for Medicinal Products and Medical Devices for conducted laboratory analysis.

Ss. Cyril and Methodius University
Faculty of Pharmacy – Skopje
Center for Drug Quality Control
Majka Tereza 47,
POB 36, 1000 Skopje, Republic of Macedonia
Account: 100000000063095
Bank account: 160010455378827 income code 723813 program 41
Tax number: 4080009100227
Depositor: National Bank of RM

Ss. Cyril and Methodius University
Faculty of Pharmacy – Skopje
Center for Drug Quality Control
Majka Tereza 47,
POB 36, 1000 Skopje, Republic of Macedonia
Tel/fax: (++389) 2 232 2143