Current Regulatory Requirements in Russia

Rubrik: europharm

(Treffer aus pharmind, Nr. 03, Seite 367 (2015))

Dranov M

Current Regulatory Requirements in Russia / The European view (Part 2)*Part 1 s. Pharm. Ind. 2015;77(2):208–212 · Dranov M · Dr, Willmar Schwabe GmbH & Co. KG, Karlsruhe
Russia still has its own format for the application dossier. Russian language is mandatory for all documents, including bibliographic references. A European dossier in Common Technical Document (CTD) format is not accepted by the Russian authorities, and its content has to be reorganised according to local requirements [ 6 ], as described below. Article 18 of law No. 61-FZ lays down the complete basic structure of the application dossier. Table 2 compares the Russian requirements to the EU CTD format. The numbers in the first column corresponds to the articles of the law; the numbers in the second column correspond to ...

Current Regulatory Requirements in Russia

Rubrik: europharm

(Treffer aus pharmind, Nr. 02, Seite 208 (2015))

Dranov M

Current Regulatory Requirements in Russia / The European view (Part 1)*Note: All terms used in this work are in compliance with the current European regulatory terminology for human medicinal products. The data-lock point for the information included was 1 May 2014. Since the regulatory framework evolves rapidly, thorough update should be done before basing any decisions on the content of this publication. · Dranov M · Dr, Willmar Schwabe GmbH & Co. KG, Karlsruhe
AF Application Form ATC Anatomical Therapeutic Chemical classification CIS Commonwealth of Independent States CoA Certificate of Analysis CPP Certificate of a Pharmaceutical Product CTA Clinical Trial Authorisation CTD Common Technical Document CV Curriculum Vitae DCP Decentralised Procedure EAN European Article Number EU European Union GMP Good Manufacturing Practice HPLC High-performance liquid chromatography INN International Non-proprietary Name MAA Marketing Authorisation Application MAH Marketing Authorisation Holder M.D.R.A. Master of Drug Regulatory Affairs MoH Ministry of Health MRP Mutual Recognition Procedure ND Normative Documentation (documentation on quality) PIL Package Information Leaflet PSUR Periodic Safety Update Report QP Qualified Person QPPV Qualified Person for Pharmacovigilance SmPC Summary of Product Characteristics TLC Thin-layer chromatography USSR Union of Soviet Socialist Republics or Soviet Union WTO World Trade Organization Since the early 1990s, the new ...