Government regulations № 1510. New rules for the introduction of medical products for medica use into civil circulation.
The Russian Government adopted Government regulations № 1510 “On the order of putting medical drugs for medical use into civil circulation” (hereinafter referred to as “the Regulations”).
The Regulations were adopted in order to fulfill provisions of art. 52.1 of the Federal Law № 61-FZ April 12, 2010 “On circulation of medical products” (this article was inserted by the Federal Law № 449-FZ November 28, 2018 “On introducing modifications into certain legal acts on the matter of putting medical drugs for medical use into civil circulation”).
In lieu of mandatory certification or adopting a declaration of conformity of medical drug for human use (hereinafter referred to as “MD”) (apart from the immunobiological medical drugs (including vaccines, toxins, serums, allergens, hereinafter referred to as “IMPs”) manufacturers and companies importing MDs in Russian Federation shall provide relevant information to the Federal Service for Surveillance of Healthcare (Roszdravnadzor).
Russian manufacturers shall provide the following documents to the Federal Service for Surveillance of Healthcare for putting MDs into civil circulation under art. 52.1 of Federal Law № 61-FZ March 24, 2010 “On circulation of medical products”:
a document confirming the quality of the MD;
confirmation of an authorized person of the manufacturer of medical products on compliance of the MD with the requirements established at its public registration.
For the purposes of putting a foreign MD into civil circulation a company shall provide the following documents to the Federal Service for Surveillance of Healthcare:
a certificate of the manufacturer of medical products evidencing the compliance of the imported MD with the requirements of the pharmacopeial monograph;
confirmation of compliance of the imported MP with the requirements established at its public registration issued by a representative of the entity importing the MD into the Russian Federation and authorized by the foreign manufacturer of medical products.
In respect of the first three shipments or lots of the MPs newly manufactured in the Russian Federation or for the first time imported into the Russian Federation, a testing protocol confirming the conformity of the shipmentor lot of a MP to the quality criteria set forth in the normative documents shall be additionally provided. Such tests are conducted by the accredited Federal State Budgetary Institutions (hereinafter referred to as “FSBI” ) (FSBI “Information and methodological center for expertise, recording and analyzing circulation of medical products of the Federal Service for Surveillance of Healthcare”, FSBI “Scientific Center on Expertise of Medical Application Products of the Ministry of Health of the Russian Federation”).
The Regulations provide for procedural rules for putting MPs into civil circulation.
Rules for the provision of documents and information on MPs to be entered into civil circulation.
The rules establish the procedure for the provision of the abovementioned documents to the Federal Service for Surveillance of Healthcare via private account on the website of the Federal Service for Surveillance of Healthcare. The Federal Service for Surveillance of Healthcare posts information on shipments or lots of the MPs which are to be put in civil circulation within 3 days after the provision of the documents in the private account.
The rules for issuance of testing protocol confirming compliance of the first three shipments or lots of MPs (with the exception of IMPs) that were produced or imported in Russia for the first time with the quality criteria set forth in the regulatory documentation.
Under such rules an MPs manufacturer or an organization importing MPs in Russian Federation shall file an application to the accredited FSBI for the issuance of a testing protocol. Such application shall be accompanied by a document issued by a manufacturer of MPs confirming the conformity of the shipment or lot of a MP to the requirements established at its public registration, verified copy of regulatory documentation for MP, samples of MPs. Testing is conducted within 30 business days after the transfer of samples to the accredited FSBI. The accredited FSBI sends a testing protocol to the applicant within 3 working days after conducting such tests.
The rules for issuing a permit to put a shipment or a lot of an IMP into civil circulation, issuing an opinion on conformity of a shipment or a lot of an IMP with the requirements established at their public registration.
Specific rules for issuing a permit to put a shipment or a lot of the of an IMP into civil circulation are stipulated due to the particular importance of IMPs for human immunity. The Federal Service for Surveillance of Healthcare issues a permit to put a shipment or lot of an IMP into civil circulation (the form of such permit is provided in the Instruction of Federal Service for Surveillance of Healthcare November 29, 2019 №8966) relying on the opinion of the accredited FSBI. For obtaining an opinion from an accredited FSBI the following documents are submitted: manufacturer’s documents on stages of production and quality control of IMP shipments or lots; a document confirming the compliance of the IMP with the requirements established at the MP public registration, other documents. The accredited FSBI conducts tests and issues an opinion on the compliance of a shipment or a lot of an IMP with the requirements established at its public registration. The application for permit to enter IMP shipments or lots into civil circulation is filed electronically via Unified identification and authentication system and the private account on the official website of the Federal Service for Surveillance of Healthcare.
The rules for adopting the decision on termination of circulation of an MP shipment or a lot.
The mentioned rules stipulate that in case the procedure for putting MP into circulation is violated, the Federal Service for Surveillance of Healthcare is entitled to make a decision to terminate the MP circulation . The Federal Service for Surveillance of Healthcare makes such decisions within 5 business days starting from the date of detecting the violations of requirements to introduction of the MP to circulation and sends the decision to a manufacturer or a company that imported the MP in Russia.
The procedure of putting MPs and IMPs in circulation has been applied since November 29, 2019, the certificate of conformity or registration of declaration of conformity is not required as of the abovementioned date (Letter from the Federal Service for Surveillance of Healthcare dated November 28, 2019 No. 01И-2906/19). MPs put into circulation before November 29, 2019 are subject to storage, transportation, dispensation, distribution, transfer, use before their expiration date (art. 5 Federal Law dated 28 November, 2018 No. 449-FZ).
When the MPs are introduced into the civil circulation without the provision of the documents listed in the current survey, a company can be held administratively liable under Art. 19.7.8 of the Code of Administrative Offences (fine on officials up to 15 000 rubles, legal entities from 30 000 to 70 000 rubles). Moreover, the Federal Service for Surveillance of Healthcare is empowered to terminate the circulation of relevant shipments and lots of MPs.
Therefore, the Regulations contain new procedural provisions regarding the introduction of MPs into the civil circulation. Special control over the first three series of MPs is required since it is necessary to verify that the MPs produced under laboratory conditions are identical to the ones produced on an industrial scale. The obligation to communicate documents electronically will reduce administrative disbursements of the pharmaceutical market participants and is aimed at the acceleration of the procedures for interaction with the Federal Service for Surveillance of Healthcare.
Pharmaceutical companies (manufacturers and importers) shall abide by the provisions and the procedures of the Regulations. Otherwise an importer or an exporter may suffer from administrative liability whereas shipments or lots of a MP may be removed from circulation, which can inflict substantial material and reputational damage to a company.