Update on legislation on storage and distribution of medicinal products in Russia
The beginning of 2017 has brought significant changes to Russian pharmaceutical legislation. On January 9th the Ministry of Justice of the Russian Federation registered the Order of Ministry of Health of Russia # 646n first proposed on August 31, 2016 "On approval of the rules of good practice for storage and distribution of medicinal products for medical use". This order will come into effect on March 1, 2017.
It is well known that appropriate storage and distribution of pharmaceuticals are critical to assuring both drug efficacy and patient safety. The new legislation is aimed at establishing a new framework of regulations for storage conditions and distribution requirements of medicines; redefines quality assurance requirements, addresses issues of safety and efficacy of drugs and safeguards against potential risks of distribution of falsified, substandard and counterfeit drugs.Here are some of the highlights of the most significant changes that will be implemented on March 1, 2017.
1. Packaging and Labeling
Shipment packages now must include name, lot number, manufacture date, number of secondary packages, manufacturer identification data, including name and address of the drug manufacturer, information regarding the shelf life of the drug, storage and transportation requirements.
2. Quality Management and Assurance
The head of the manufacturing organization is required to establish a quality management system and to designate competent staff that would be responsible for its implementation and maintenance. This quality management system should be focused on employees' compliance with products' transportation and storage rules. The head of the organization approves and signs off on the documents which describe the procedures for storage and transportation of medicines, the standard operating procedures for maintenance and verification of related measuring instruments and equipment. Drug receipt, storage and distribution policies must be followed in strict accordance with the aforementioned company procedures and are subject to periodic inspections.
3. Temperature Control
One of the most important changes pertains to temperature control at storage facilities. All applicable depots must be equipped with modern temperature monitoring systems. Temperature recordings should be documented daily in designated temperature control logs/forms on paper form and/or electronically, including weekends and holidays. These logs must be kept for at least 2 years.
4. Depot Capacity
The regulations have a number of requirements for storage facilities that are being maintained by manufacturers and distributors. One of these requirements is that the size of the designated storage should be equal or larger than 150 square meters.
This is a long-awaited measure that should ensure an improved level of quality and safety of medicinal products and minimize risks to the patients.
However, these regulations face considerable criticism. It is believed that it will have a strong prejudicial effect on the secondary distributors. Many of such organizations are small or have rather rudimentary distribution hubs, especially in remote locales. As it stands today, a large number of these secondary distributors will not be able to satisfy the requirements that are being put forth in new regulations and thus will become banned from participation in regional distribution of medicines. Some may not be able to survive the change and will have to leave the market. This may result in temporary shortage of drugs in Russia’s remote regions. On the other hand, it may open doors to large international players with established logistics and know-how and will allow them to expand their market share.We will continue to monitor the situation and will keep our readers updated.