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From March 1st, 2018 Importers Will Have to Meet the Requirements for a Quality System

01/ 02/ 2018

We draw attention of the subjects of the pharmaceutical market that on March 1st, 2018, the Conditions of Licensing the Production of Medicines, Wholesale and Retail Trade in Medicines, Import of Medicines (other than APIs) No. 929 approved by the Cabinet of Ministers as of November 30th, 2016 came into force. The Conditions establish the following obligations for importers of medicinal products (paragraphs 194-200, 258, 259, 265):

  • To ensure the quality of medicines, guarantee that a pharmaceutical quality system is introduced and functioning, including relevant elements of good manufacturing practices, good distribution practices, good storage practices and quality management in relation to medicines import activities.
  • It is necessary to establish a system for selecting and storing samples of medicines.
  • No series of medicinal products can be authorized for sale or delivery until the authorized person of the licensee confirms its compliance with the requirements of the registration dossier and import license.
  • It is necessary to carry out the stability tests of medicinal products together with the manufacturer after they are brought to the market (or it can be done by one subject upon agreement).
  • In relation to external (outsourcing) activities, a contract must be concluded between the customer and the contractor. Before the commencement of activities it is necessary to assess the legality, suitability and competence of the contractor; the customer should be able to conduct audits.

The specified requirements of the legislation should be settled from March 1st, 2018 in a contractconcluded by a licensee (importer) with a foreign manufacturer and / or a supplier of the medicinal product, and / or the owner of the registration certificate. In such a contract, the requirements of good manufacturing practices harmonized with the EU legislation concerning the import should be considered:

  • trained personnel with the necessary qualifications;
  • proper facilities and areas;
  • equipment and proper maintenance;
  • written procedures and instructions based on the pharmaceutical quality system;
  • appropriate means for storage and transportation;
  • instructions and procedures set out in the form of specific requirements for the implementation of processes (operations).

Let us remind you that earlier in accordance with the Conditions of Licensing the Economic Activities for the Import of Medicines approved by order of the Ministry of Health No. 143 as of February 20th, 2013 these requirements had to become mandatory for importers since March 1st, 2016.

Then, due to the entry into force on June 28th, 2015 of the Law of Ukraine “On Licensing of Economic Activities”, which provides that licensing conditions for all activities must be approved by the Cabinet of Ministers of Ukraine, there was a legal conflict. New Conditions of Licensing the Production of Medicines, Wholesale and Retail Trade in Medicines, Import of Medicines (other than APIs) were approved by the Cabinet of Ministers only on November 30th, 2016. The above requirements for the quality system of importers with some modifications were transferred to a new document with a deferred entry into force.

Thus, before March 1, 2018 importers should bring their activities in line with the current Licensing Conditions.

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