CONSULTATIONS ON QUALITY ISSUES

Licensing of import for medicines

According to Ukrainian legislation, implementation of economic activity on importation of medicines (except for active pharmaceutical ingredients) shall be licensed.

Licensing conditions are approved by the Decree of the Cabinet of Ministers of Ukraine №929 dated November 30, 2016 “On the approval of licensing conditions for the implementation of economic activity on the production of medicines, wholesale and retail trade of medicines, import of medicines (except for active pharmaceutical ingredients)”.

Medicines shall be imported with the availability of:

  • valid license on importation of medicines with up-to-date supplement (the list of medicines that are imported into the territory of Ukraine);
  • importer’s file approved by the enterprise
  • regulatory and technical documents and regulations establishing requirements for the medicine, its packaging, storage conditions and shelf life, and methods of medicine’s quality control.

Importation of medicines shall be carried out in compliance with the requirements of good manufacturing practices, good distribution practices, and good storage practices.

For getting legal opportunity of importation of medicines and obtaining of the relevant license, the importer shall ensure:

  1. compliance of material and technical base, staff qualification, as well as the conditions for implementation of quality control of medicines that will be imported into the territory of Ukraine, compliance with the requirements of regulatory documents on importation, quality control or production of medicines;
  2. compliance with the requirements of the legislation regarding the quality of medicines to be imported into the territory of Ukraine, quality control and its wholesale trade;
  3. availability of an authorized person (authorized persons) responsible for issuing permit for the release (sale) of a batch of medicines;
  4. availability of storage areas, premises for acceptance, warehousing and storage, in particular, quarantine storage, quality control sampling, sale of medicines.
  5. Introduction of pharmaceutical quality system that guarantees:
  • opportunity to continuously supply products with appropriate quality level;
  • clearly determines responsibilities and duties of the licensee’s management staff;
  • management of external (outsourcing) activity;
  • when producing a batch, taking into account the results of monitoring products and processes, investigation of deviations, taking measures for avoiding potential deviations that may occur in future;
  • change management;
  • application of an appropriate level of analysis of the main causes in the investigation of deviations, alleged product spoilage and other problems (in particular, using quality risk management principles);
  • failure to sell and deliver medicines before getting approval of the authorized person on its release (sale) thatproves that each batch of medicines is produced and controlled in accordance with the requirements of the registration dossier and any other requirements for production, control and release of medicines;
  • implementation of sufficient measures for ensuring medicines quality throughout the shelf life at all stages of circulation;
  • availability of self-inspection and/or quality audit procedure that regularly evaluates the effectiveness and applicability of pharmaceutical quality system.

«Archimed» Company will assist you in fulfilling of the licensing requirements providing counselling at all stages of the process:

  • selection of warehouse;
  • hiring staff of appropriate qualification;
  • writing of the importer’s file;
  • implementation of pharmaceutical quality management system;
  • support during inspections by the State Service for Medicines and Drug Control;
  • implementation of corrective measures;
  • obtaining of the license for importation of medicines.

You can get more detailed consultation by writing us a short request or by calling the number below.