MZ: New obligations for pharmacies

The draft regulation specifies the requirements for entities operating pharmacies and updates them in a way that ensures compliance of the draft regulations with the applicable statutory provisions.

The introduced changes will allow for the adjustment of the requirements specified in the regulation to the regulations contained in other legal acts and the current realities related to running a pharmacy, in particular the method of keeping, verifying and securing pharmacy documentation kept in an electronic system, which will allow for limiting the keeping of this documentation in the paper version.

The regulations contained in the new ordinance will make it possible to increase the supervision over the quality of pharmaceutical raw materials, medicinal products and medical devices stored in a pharmacy by covering the conditions of their storage with 24-hour supervision, as well as introducing the obligation to periodically inspect prescription drugs, pharmaceutical drugs and homeopathic medicinal products prepared in pharmacies and the equipment necessary for their preparation, which will improve the quality and safety of these drugs and products used by patients.

In order to ensure the appropriate quality of medicines, it is foreseen that pharmacies will be obliged to monitor the temperature and humidity of rooms 24 hours a day where prescription and pharmacy medicines as well as homeopathic medicinal products are prepared, as well as in rooms and cooling devices used for storage of medicinal products, pharmaceutical raw materials and medical devices.
The solutions adopted are also intended to ensure better supervision over medicines prepared by pharmacies. In shaping the provisions of the proposed regulation, the solutions applied in the case of medicinal products placed on the market by manufacturers were followed. It is planned to use the drug quality control laboratories operating at the voivodeship pharmaceutical inspectorates to control devices used to prepare prescription drugs, pharmaceutical drugs and homeopathic medicinal products, in order to ensure the appropriate quality of these drugs and products.
The requirements for keeping pharmacy documentation were updated, based on the current regulations, as well as the method of archiving data, in particular those kept in the electronic system.

In order to verify persons performing professional activities, the method of access and confirmation of the identity of a professional employee issuing or receiving the drug has been regulated.

The obligation to secure access to the account after the employee leaves the workplace was provided for, and the method of storing and securing data in the electronic system was specified.

The scope of the pharmacy documentation was extended to include documents related to the free acquisition, sale or inter-warehouse transfer of medicinal products, records of the conditions for the preparation and storage of medicinal products.

The activities performed while admitting medicinal products to the pharmacy were extended by the obligation to control the conditions in which transport took place and the obligation to verify the authenticity of the product in accordance with the Commission Delegated Regulation (EU) 2016/161 of October 2, 2015 supplementing Directive 2001/83/EC of the European Parliament and of the Council by laying down detailed rules concerning safety features placed on the packaging of medicinal products for human use (Journal of Laws UE L 32 of 09/02/2016, p. 1).

Project: TU

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