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Duplicate registration certificate for medical products
In Russia, the sale, storage and transport of medical products and other operations involving such products are only permitted where the product in question is accompanied by a valid registration certificate (RC). This requirement is established by the provisions of Article 38 of RF Federal Law No. 323-FZ dated 21 November 2011, which deals with issues of public health and welfare. Thus, in the event that the current RC is lost or ruined, the certificate-holder must submit an application for the issuance of a duplicate document.
Issuance of duplicate RC
The state agency responsible for implementation of the state-registration procedure is Roszdravnadzor. It is also tasked with the issuance of duplicate registration certificates in those cases envisioned by applicable legislation. The procedure itself is not particularly burdensome on the applicant. All that the applicant needs to do is to submit an application for the document’s issuance to the responsible oversight agency. In the event that the request is prompted by damage to the previously-issued certificate (e.g. it got wet or torn), the application must be enclosed with the ruined certificate.
The registration dossier serving as the basis for the document’s issuance is compiled independently by Roszdravnadzor on the basis of the product documentation it already has in its archives. Pursuant to Clause 53 of RF Governmental Resolution No. 1416 dated 27 December 2012, which establishes the rules governing the procedure for the state registration of medical products, the processing of such an application should take no more than 7 business days. This work results in the responsible agency processing a new registration certificate, stamped “duplicate.” The duplicate RC for medical products also features information indicating that the original document is no longer valid: this is done to prevent lawbreakers and unscrupulous market participants from using it for their own purposes.
Processing cost
The processing and issuance of a duplicate is a paid state service. To obtain one, the applicant must pay the respective state fee, as determined by the provisions of Article 333.33 of the RF Tax Code. At present, the fee is RUB 1,500. It would be prudent to affix the payment receipt to the application for the issuance of a duplicate. At the Center for the Registration of Medical Products, you can order a comprehensive service for the issuance of a new registration certificate to replace a lost or ruined certificate. Our specialists will take on the responsibility of drawing up the application, preparing the necessary attachments and submitting it to Roszdravnadzor, and will also oversee the process to ensure that processing is completed in accordance with the requirements of applicable legislation.
