The Federal Veterinary and Phytosanitation Service ("Rosselkhoznadzor") has issued Order No. 605 of June 13, 2018 (registered with the Ministry of Justice on July 20, 2018), entitled Approval of the Procedure for Veterinary Medicine Quality Control Sampling (the "Procedure"). The Procedure came into force on 3 August 2018. As of that date, Rosselkhoznadzor will exercise its powers under Art. 9 of Federal Law No. 61-FZ of April 12, 2010 On the Circulation of Pharmaceuticals to carry out quality control sampling of veterinary medicines ("VM") in accordance with the Procedure.
The objective of the sampling process is to ensure that VM and pharmaceutical substances meet the requirements set down by the official listing in the pharmacopeia or, if the substance is not listed, the requirements set down by statute or regulations.
The control process will enable the regulator to record the details of series and consignments of VM going into circulation in the RF. Officials will collect samples for laboratory testing, check that they meet statutory or regulatory requirements (the Procedure also sets out the grounds for and stages of the sampling process, the number of samples that should be taken and testing time frames) and make a decision as to whether the VM can go on to be distributed, whether they should be made subject to batch release testing (if more than one instance of non-compliance is found) and whether checks should be carried out at the entity that is putting the VM into circulation. All costs involved in batch release controls will be paid for by the producer or the holder or owner of the registration certificate.
If the expert report produced following sample testing does not clear the VM, Rosselkhoznadzor will issue a decision suspending the circulation of the VM batch on RF territory or, if a consignment of VM is found to be defective or fake, to withdraw it from circulation and destroy it (there is an official process for this). Notice of this will be published on Rosselkhoznadzor's website.
In addition, Rosselkhoznadzor will send the entity putting the VM into circulation (for VM registered in the RF) or the EEU controlling authority (for VM registered in another EEU member-state) an instruction for them to submit to Rosselkhoznadzor a program for averting threats to animal life and health. The program will have to be sent to Rosselkhoznadzor within 10 days.
The owner of defective or fake VM will be given 30 working days to comply with Rosselkhoznadzor's decision by withdrawing the VM from circulation and destroying them, although it will be possible to challenge decisions through the courts. In extreme cases, where urgent action is needed, Rosselkhoznadzor will have the power to order the owner of a consignment of VM to withdraw them from circulation within 2 days.
If other consignments of the batch of VM are in circulation and are found to meet statutory/regulatory requirements, Rosselkhoznadzor will issue a decision allowing them to remain in circulation and will publicly advise the entities distributing them of this.
The Procedure includes recommended forms for the sample request that Rosselkhoznadzor will send entities that distribute VM and the document recording the fact that samples have been taken and returned (called a sampling and dispatch act).
It is also important for VM producers to note that, under section 7 of the Procedure, entities that manufacture VM in Russia and/or import them to Russia will now have to give Rosselkhoznadzor the following details of batches and consignments of VM that are being put into circulation:
- the (invented) name of the VM;
- the INN;
- the form in which it is being released and number of units in a pack;
- the manufacturer's name;
- the amount of the batch/consignment being put into circulation on RF territory (for medicines – in terms of the number of packs; for pharmaceutical substances, in terms of units of measurement);
- the registration certificate number or the number of the record of the pharmaceutical substance in the State Medicines Register;
- the address of the site at which the consignment is being stored following confirmation by the manufacturer's authorized representative that the medicines meet the requirements set down during the state registration (release permit) process (for manufacturers in the RF);
- the date that the manufacturer's authorized representative confirmed that the medicines meet the requirements set down during the state registration (release permit) process (for manufacturers in the RF);
- the name of the entity putting the medicines into circulation on RF territory (for those importing to the RF);
- the address of the site at which the consignment is being stored following clearance by the customs authorities through the customs regime it was declared under (for those importing to the RF); and
- the date that the customs authorities cleared the consignment of medicines (for those importing to the RF).
This information has to be submitted within 5 business days from the time at which the manufacturer's authorized representative confirms that the batch of VM medicines meets the requirements set down during the state registration (release permit) process (for manufacturers in the RF) or from the date that it is imported to RF territory from an EEU country.
It is envisaged that these details will, at some future point, be entered in a Rosselkhoznadzor data management system 1 – now at the stage of development – then used to generate a VM quality control sampling plan. According to Rosselkhoznadzor (at http://fsvps.ru), during the transition period, details of batches and consignments of VM will need to be submitted by e-mail, to firstname.lastname@example.org.
The Procedure now sets down the main rules under which the authorized body will carry out quality control sampling for VM in circulation. The process has been made easier to understand and more predictable for entities involved in VM and there is a procedure for appealing against the regulator's decisions.
Dentons provides comprehensive legal services for Russian and foreign manufacturers of veterinary medicines and legal support during Rosselkhoznadzor inspections. It offers audits of product portfolios and develops recommendations to mitigate and eliminate risks identified.
1. See Decree of the RF Government No. 1140 of November 7, 2016 On the Process of Creating, Developing and Operating the Federal State Veterinary Data Management System.
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