Quality Control

The Medicines and Medical Devices Agency has the authority to conduct laboratory quality control of medicinal products and medical devices. For the performance of these activities within the Agency: the National Control Laboratory has been established conducting the following:

A) Quality control of a medicinal product prior to granting a marketing authorization for the medicinal products includes:

  1. quality control of a medicinal product during the procedure for issuing the marketing authorization for medicinal products, if this is needed;
  2. quality control of the first batch release after the marketing authorization for a medicinal product has been granted;
  3. quality control of a medicinal product during the procedure for the variation, or the renewal of the marketing authorization, if this is needed;
  4. obligatory quality control for each batch release of vaccines, sera and other products made of blood;
  5. repeated quality control for a medicinal product that has the batch release certificate of the manufacturer, made by the national manufacturers that do not apply, or do not fully apply the guidelines for Good Manufacturing Practice, and in other cases if needed;
  6. repeated quality control for a medicinal product that has the batch release certificate of the manufacturer, made by the national manufacturers that do not apply, or do not fully apply the guidelines for Good Manufacturing Practice, and n other cases if needed;

B) Quality control after granting the marketing authorization and after marketing a medicinal product, namely:
by taking random samples;

  1. by testing the quality of sensitive medicinal products;
  2. by taking random samples;
  3. by solving identified problems;
  4. obligatory quality control for each batch release of vaccines, sera and other products made of blood;
  5. for every batch release of an imported medicinal product.

V) Quality control of magistral and galenic medicinal products


QUANTITY OF SAMPLES FOR QUALITY CONTROL OF DRUGS
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Activities regarding the evaluation of documentation during the procedure for issuing the authorization, activities regarding the membership in the European Pharmacopoeia Committee, as well as the quality assurance activities are performed in the National Control Laboratory.

Quality control is conducted by highly educated experts of the National Control Laboratory who work with the newest qualified and calibrated equipment, using validated analytical methods.