medicinal products, packaging compounded drugs, supervision over compounded drugs, pharmacy records, procedure for the receipt of medicinal products at a pharmacy

Regulation of the Minister for Health on basic conditions for the operation of pharmacies

The draft Regulation stipulates that pharmacies will be required to ensure 24/7 monitoring of the temperature and humidity in the rooms where magistral and officinal drugs and homeopathic medicinal products are prepared, as well as in the rooms and refrigeration devices used to store medicinal products, pharmaceutical raw materials and medical devices. The measures adopted are also intended to ensure better supervision over compounded medicines. The draft provides for an obligation to submit a compounded drug or product for testing at least once every three years in order to ensure the quality of these drugs and products. The cost of the testing is borne by the pharmacy operator.

The requirements for the keeping of pharmacy records have been updated based on the regulations currently in force, and the manner in which data is to be archived, in particular when kept in a computerised system. In order to verify persons carrying out professional activities requiring particular qualifications, the manner in which access and the confirmation of the identity of qualified staff dispensing or receiving drugs are carried out has been regulated. The draft provides for an obligation to secure access to an account after the employee leaves the workplace and the manner in which the data will be stored and secured in the computerised system. The scope of the pharmacy records to be kept has been extended to include documents relating to unpaid acquisition, disposal or transfer of medicinal products between warehouses, and a record of the compounding and storage conditions of medicinal products.

The medicinal product reception activities carried out at a pharmacy have been extended to include the obligation to control the conditions under which the transport took place and the obligation to verify the authenticity of the product, in accordance with Commission Delegated Regulation (EU) 2016/161 of 2 October 2015 supplementing Directive 2001/83/EC of the European Parliament and of the Council by laying down detailed rules for the safety features appearing on the packaging of medicinal products for human use (OJ EU L 32 of 9.2.2016, p. 1, as amended).