New good practice for the storage and transportation of medicines intended for human use
Law firm Pepeliaev Group advises that on 9 January 2017 the Russian Ministry of Justice registered Order No. 646n of the Russian Ministry of Healthcare “On approving the Good Practice for the Storage and Transportation of Medicines Intended for Human Use” dated 31 August 2016 (“GPST”).
GPST will come into force on 1 March 2017.
GPST was developed in pursuance of Federal Law No. 61-FZ “On the circulation of medicines” dated 12 April 2010 for the purpose of establishing, across the territory of Russia, uniform requirements for the conditions under which medicines are stored or transported.
It should be taken into account that Resolution No. 80 of the Eurasian Economic Union (EAEU) dated 3 November 2016 approved the rules of the Good Distribution Practice (GDP) within the EAEU,. These rules regulate a wider range of matters that stretches beyond storage and transportation. The Federal Law “On the circulation of medicines” provides that the federal executive authority should approve both Good Distribution Practice and Good Practice for the Storage and Transportation of Medicines.
Therefore GPST will not be the only good practice document regulating the wholesale segment.
Please find below the content of GPST.
The primary emphasis of the GPST is that quality should be maintained systematically at all stages of storage and transportation. The manager of a party involved in the circulation of medicines should implement and maintain a quality control system by approving a set of documents.
The new Practice has established the scope of requirements and obligations for employees. In particular, employees should have specific qualifications and work experience. They are also required to undergo training (instruction) appropriate for their positions when they work with medicines for which special storage conditions have been established.
GPST provides for a whole range of requirements as to premises. The most important of these are requirements regarding the floor space of such premises, the zones into which they should be divided, lighting, and prohibitions on the storage of certain products together with medicines, as well as requirements for the temperature range, the interior finishing and non-admittance of certain persons to the premises.
GPST has clarified the list of documents regarding the storage and transportation to which it will apply. These documents include standard operating procedures, instructions, agreements and reports.
The new requirements define the process of the transportation of medicines and also establish the actions of an agent involved in the circulation of medicines in this sphere.
A list of requirements has been introduced which parties involved in the circulation of medicines should comply with during transportation. These are connected with the expiry dates of medicines, documentation, risk assessment, the storage temperature regime, means of transportation and equipment.
Please note that the party responsible for ensuring compliance with the requirements of GPST during the transportation of medicines is the party involved in the circulation of medicines.
In particular, GPST clarifies that medicines should be transported using transportation packaging that does not adversely affect the quality, effect and safety of the products and that ensures they are protected. Criteria have been established for the selection of such packaging.
We recommend that all parties operating on the market for medicines familiarise themselves with the new Good Practice for the Storage and Transportation, and take into account that when it comes into force, new requirements will be introduced for the system of managing the processes of storing and transporting medicines. Should you encounter any ambiguities, we recommend that you promptly send requests to the state authority. You can do this independently, through non-commercial sector-based associations, or by using the help of our firm’s experts.
Pepeliaev Group's lawyers have significant experience in providing advice to and representing clients in matters connected with the circulation of medicines. They stand ready to provide comprehensive assistance and legal support on these matters in connection with the developments discussed above. This may include drafting legal advice and documents as well as providing assistance to clients during audits by controlling authorities.
GPST will come into force on 1 March 2017.
GPST was developed in pursuance of Federal Law No. 61-FZ “On the circulation of medicines” dated 12 April 2010 for the purpose of establishing, across the territory of Russia, uniform requirements for the conditions under which medicines are stored or transported.
It should be taken into account that Resolution No. 80 of the Eurasian Economic Union (EAEU) dated 3 November 2016 approved the rules of the Good Distribution Practice (GDP) within the EAEU,. These rules regulate a wider range of matters that stretches beyond storage and transportation. The Federal Law “On the circulation of medicines” provides that the federal executive authority should approve both Good Distribution Practice and Good Practice for the Storage and Transportation of Medicines.
Therefore GPST will not be the only good practice document regulating the wholesale segment.
Please find below the content of GPST.
1. Requirements have been established for ensuring the quality of storage and transportation
Such requirements should be introduced so that all employees comply with uniform rules when medicines are stored and transported. GPST emphasises that such documents should contain requirements regarding the procedure for maintaining and inspecting measuring devices and equipment. There are also requirements regarding the keeping and storage of records and reports, as well as the acceptance, transportation and allocation of medicines and regarding how control should be organised of the compliance with the standard operational procedures.
Statutory control over outsourced activities has been enshrined. For example, GPST determines the scope of the client’s and the service provider’s liability for such activities.
2. Requirements as to employees have been set
3. Requirements have been determined for premises and equipment for the storage of medicines
The authors of the law have established the measures that should be taken to ensure that medicines of certain categories are stored separately.
With respect to equipment, GPST has established zones into which premises should be divided for the storage of products, and has specified the list of the equipment to be used during the storage and transportation of medicines. It has set a range of requirements for repairs to and the maintenance, checking and calibration of equipment; in particular, GPST provides that this work should be performed in accordance with an approved planning schedule.
4. Requirements for documentation have been made uniform
GPST provides that the content of such documents should be understandable, straightforward and should not permit ambiguous interpretations. The Practice makes reference to the legislation on archiving, thus making provision for how long such documents should be stored.
5. Rules have been established for the transportation of medicines
The Practice establishes the scope of liability of a party involved in the circulation of medicines with respect to transportation. The party involved in the circulation of medicines should:
- take measures to minimise the risk of falsified, counterfeit or poor-quality medicines entering the market;
- take into account the requirements and store the documentation that constitutes the registration dossier;
- properly arrange medicines on shelves and palettes;
- take measures to ensure protection from light sources.
Please note that the party responsible for ensuring compliance with the requirements of GPST during the transportation of medicines is the party involved in the circulation of medicines.
6. Requirements have been made uniform regarding transportation and unit packaging as well as the marking of medicines
With respect to the marking of the transportation packaging, a list of information has been established which should be placed on such packaging:
- name;
- series of medicines;
- manufacturing date;
- number of secondary (consumer) packs;
- information on the manufacturer including names of the manufacturer's locations;
- expiry date and terms and conditions for storage and transportation;
- cautionary warnings and manual handling signs.
PG comments: In our opinion, when GPST comes into force, it will help to solve the problem of ensuring the quality of medicines. It will enhance control over the safety of products at all stages from manufacturing to their sale by wholesale and retail traders. At the same time, the regulatory authority must be ready to give a timely and on-point answer to requests seeking explanations of certain provisions of GPST. It must apply a unified risk-oriented approach ensuring the uniform implementation of GPST. Otherwise, the unclear requirements and differences in understanding of GPST on the ground may lead to a significant increase in the administrative burden over the wholesale market.