Newsletters India/Framework Agreement for 4 Years

Buyer Name
GTAI GERMANY TRADE AND INVEST GESELLSCHAFT FÜR AUßENWIRTSCHAFT UND STANDORTMARKETING MBH
Total no. of suppliers
1
Supplier name
T&A CONSULTING

Description

A: Monthly newsletter about important legislative projects in India's pharmaceutical, medical biotechnology and in-vitro industries;B. Monthly newsletter about important legislative projects in India's medical devices technology industry.A: Monthly newsletter about important legislative projects in India's pharmaceutical, medical biotechnology and in-vitro industriesTarget group: German pharmaceutical, medical biotechnology and in-vitro diagnostic companies exporting or planning to export to India.Summary of all newly passed and adopted legal regulations (including their status within legislative proceedings and their date of coming into force) that are or might be important for foreign companies exporting to India. Most relevant topics are:— general developments in the field of regulatory affairs and in drug registration in India such as requirements on GMP inspections or changes of requirements for clinical and preclinical development, etc.,— drug pricing, when stipulated by the government,— requirements for drug packaging, instruction leaflet and labeling:—— changes of summary of product characteristics (SMPC),—— changes of patient information leaflet (PIL),—— changes in drug licensing,—— distribution and retail segment of pharmaceuticals,—— changes in export/import regulations as well as in customs procedure.— the latest development of legislative projects in the pharmaceutical and medical biotechnology sector of international importance (including changes in agreements with third countries: e.g. mutual acceptance of registrations),— assortment restrictions for companies,— information about advertising and promotion of drugs,— changes in structure and tasks of health authorities (e.g. department of health and family welfare has new sphere of competence),— changes in regulations for warehouses (e.g. new rules for consignment stock in India),— general legislative projects in the Indian pharmaceutical sector.B.Monthly newsletter about important legislative projects in India's medical devices technology industry.Target group: German medical devices companies exporting or planning to export to India summary of all newly passed and adopted legal regulations (including their status within legislative proceedings and their date of coming into force) that are or might be important for foreign companies exporting to India. Most relevant topics are:— general developments in the field of regulatory affairs in medical device registration and notification in India incl. legal and technical requirements, i.e,— registration framework with its requirements on:— classification/risk analysis (incl. current revised standards and classification catalogue) technical documentation for safety assessment,— clinical documentation for proof of effectiveness incl. exemptions,— Product technical requirement (PTR) and labelling/identification requirements,— type testing,— examination of quality management systems,— special procedure for innovative devices (pilot),— requirements for priority review procedure,— post-market compliance/requirements on:— post-market surveillance (PMS) incl,— Implementation of Market-Authorization-Holder (MAH)-System and liability and reporting system for adverse events,— recalls (incl. expansion of application scope),— re-certification and re-audits,— medical device pricing, when stipulated by the government,— distribution and retail segment of medical devices incl. specifics for reimbursement, tendering,— information about advertising and promotion of medical devices/therapeutic products,— changes in export/import regulations as well as in customs procedure,— changes in relevant IPR regulations,— general legislative projects in the Indian medical technology sector incl. latest development of legislative projects of international importance (including changes in agreements with third countries: e.g. mutual acceptance of registrations).

Date published
16/08/2019

OCID
ocds-0c46vo-0133-388481-2019
Categories (CPV)
22200000 - Newspapers, journals, periodicals and magazines

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