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Rules for inspection of distributors of medicines have been adopted in Belarus

 Rules have been adopted for inspection of distributors of medicines for conformity with EAEU GDP

 A requirement to inspect medicine distributors has been introduced by Presidential Edict No. 499 “On medicines circulation” (“Edict”). In furtherance of the Edict the Council of Ministers adopted Resolution No. 191 on 1 April 2020 (“Resolution”), laying down a Regulation on the procedure for inspections for conformity with the Rules for good distribution practice of the Eurasian Economic Union and issue of a decision as to the result (“Regulation”).
According to the document the Ministry of Healthcare is responsible for guidelines and organising inspections. The Ministry will also issue decisions on conformity with GDP EAEU. For this purpose, a new administrative procedure is envisaged. To obtain a decision an inspection by pharmaceutical inspectors of the State agency “Gospharmnadzor” (“Agency”) must first be carried out. Inspections will be carried out according to an annual plan, to be published not later than 10th of January each year.
A distributor included in the plan must be notified. The distributor then files an application for inspection enclosing a quality control policy, a description of the premises and equipment and a list of personnel responsible for complying with GDP EAEU in an established format.
The inspection will be performed under an agreement concluded with the Agency. Distributors (i.e. companies involved in pharmaceutical activities including wholesale trade in medicines under licence) will be inspected for conformity with all chapters of GDP EAEU. There is a list of cases when inspectors must collect samples of medicines established in the Regulation.
Following inspection, a report and notification are sent to the distributor. If the results of the inspection are positive, notification is also sent to the Ministry of Healthcare. After that the distributor may apply for issuance of a decision on conformity. The procedure takes 5 days and is free of charge. The decision is valid for three years. Information on decisions issued will be published on the Agency’s web-page.
The Regulation will come into legal force on 1 December 2020.