The rules for proper storage and transportation of medicines* approved by the Russian Ministry of Public Health (the “Rules”) will take effect from 1 March 2017. The document is aimed at preserving the quality of medicines throughout the supply chain, from the producers to the consumers. In fact, these Rules represent the Russian equivalent of the guidelines on Good Distribution Practice (“GDP”) that have been in place in Western countries for many years.
The adoption of the Rules is the next logical step in the harmonisation of the Russian laws on circulation of medicines with the European laws. The concept of "good practices" has long been successfully applied in the EU and US pharmaceutical industries. Russia continues to take steps to draw on this positive experience. Less than a year ago, it approved the Good Clinical Practice*, which regulates clinical trials. Along with these Rules, the Good Pharmacy Practice* will enter into force to regulate the retail sale of medicines through pharmacy chains, etc.
The Rules will affect the activities of all pharmaceutical market players, including manufacturers, distributors and pharmaceutical warehouses. These players will need to ensure that their warehouses and logistics processes meet the new requirements, approve several new documents, check their existing quality systems and provide the necessary training for their employees.
New requirements for premises
Any premises for storing medicines should include a new separate area for storing fake, substandard and counterfeit medicines (this is in addition to the areas for acceptance of medicines and main drugs storeroom, as well as space for storing medicines that require special conditions and quarantine). This is intended to provide additional protection against such medicines being put on sale. Moreover, the Rules oblige the owners of premises to take any other measures in order to minimise the risk of circulating fake, counterfeit and substandard medicines.
Access to medicines storage premises will be significantly restricted. With effect from 1 March, only employees authorised according to their company’s internal documents can enter any medicine storage premises (previously such restriction applied only to narcotic and highly powerful drugs). At the same time, companies are required to put in place security systems that prevent unauthorised access to their medicine storage premises.
The total area of warehouses used by manufacturers and distributors must correspond to the volume of stored medicines but, in any case, it must be at least 150 square meters. The fit-out of such premises should prevent the accumulation of dust or penetration of insects.
Stricter requirements for staff
From 1 March, all employees involved in the storage and transportation of medicines will be subject to stricter requirements. Such employees will have to undergo regular briefings according to the schedule approved by their company. At the same time, all employees dealing with medicines that require special storage conditions (e.g. thermolabile drugs) will have to receive special briefings that reflect the specificity of their positions. All documents confirming that the relevant employees have been duly trained must be kept in the company’s archive and be available for audit.
Each company’s CEO will have to issue a separate order appointing an employee who is responsible for implementing and maintaining the quality system, monitoring the quality system’s efficiency, following up on compliance and updating standard operating procedures (“SOPs”).
Each company engaged in the storage and transportation of medicines must have its quality system and SOPs that regulate the course of action for its employees who handle the storage and transportation of medicines, the procedure for maintaining and calibrating measuring instruments, records keeping and reporting, as well as arranging for control over the implementation of such procedures.
For each fact of violation of the Rules or the SOPs, companies will be required to conduct an internal audit and develop remedial measures to eliminate the violations.
If a pharmaceutical company outsources the storage and/or transportation of medicines to an authorised warehouse (as is often the case with foreign pharmaceutical companies in Russia), the Rules require such company to constantly monitor the activities of such warehouse as to whether it complies with all the requirements on quality control of stored medicines. It is established that a contract between a pharmaceutical company and a warehouse must contain provisions on the warehouse’s responsibility for its operations, and before entering into such a contract, the potential client of the warehouse must audit the latter as to whether it has all the necessary licences, permits, premises, equipment and staff.
Failure to comply with these new Rules may be qualified by the regulatory authorities as a gross violation of the licensing requirements in the pharmaceutical industry. The offender may, as a minimum, be fined between RUB 100,000 and RUB 200,000 (approx. EUR 1,655 - 3,310) and ordered to remedy the violation. In the worst case, the court (if it deems that the violations are critical) may suspend the offender’s activities for up to 90 days and revoke its pharmaceutical licence.
Conclusions and necessary steps
There are all grounds to believe that the new requirements for warehouses, quality systems and professionalism of pharmaceutical warehousing staff will help reduce the number of substandard medicines on the market. However, market players should ensure that they are ready to comply with the new Rules and promptly take the necessary measures if necessary, namely:
- All the owners and tenants of pharmaceutical warehouses need to ensure that their warehouses meet all the new requirements applicable as of 1 March 2017, including those regulating the minimum total areas of such facilities, the availability of the necessary zones and entrance control systems, etc.
- Foreign pharmaceutical companies operating or intending to operate through authorised Russian warehouses should ensure that their contracts with the warehouses’ owners provide for responsibility for proper storage and that all the necessary valid licences and permits are in place.
- All companies involved in the storage or transportation of medicines should ensure that they have or develop and adopt any missing SOPs regulating the storage and transportation of medicines, the procedure for maintaining and calibrating instruments and equipment, records keeping and reporting, procedure for acceptance, transportation and placement of medicines.
- All companies involved in the storage or transportation of medicines should approve their schedules for the training of staff responsible for medicines storage and transportation, as well as internal audit schedules.
* in Russian