24/10/2018
Learn more about marketing, manufacturing, packaging & labeling, and advertising in Russian pharma. Prepared in association with Lidings, a leading global law firm, this is an extract from The Pharma Legal Handbook: Russia, available to purchase here for USD 99. 1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products? The authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications has been already covered by Question 3 in Regulatory, Pricing, and Reimbursement Overview. In addition, biomedical cellular products (“BCP”), i.e. products containing cultivated living cells of human, used in various studies and in medicine, can be classified as “other medicinal products”. BCP authorization process includes obligatory receiving of marketing authorization. BCP manufacturers can only distribute them to: other BCP manufacturers for BCP manufacturing; scientific organizations, education organizations for carrying out scientific research; healthcare organizations. 2. What…
Upcoming reforms in Russia’s pharma environment. Prepared in association with Lidings, a leading global law firm, this is an extract from The Pharma Legal Handbook: Russia, available to purchase here for USD 99. 1. Are there proposals for reform or significant change to the healthcare system? An automated system of monitoring the…
All about patents and trademarks in Russia. Prepared in association with Lidings, a leading global law firm, this is an extract from The Pharma Legal Handbook: Russia, available to purchase here for USD 99. 1. What are the basic requirements to obtain patent and trademark protection? Patents The Russian law provides protection…
The lowdown on the situation regarding the product liability in Russian Pharma. Prepared in association with Lidings, a leading global law firm, this is an extract from The Pharma Legal Handbook: Russia, available to purchase here for USD 99. 1. What types of liability are recognized in your jurisdiction? There are…
A brief overview of the situation regarding traditional medicines and OTC products in Russia. Prepared in association with Lidings, a leading global law firm, this is an extract from The Pharma Legal Handbook: Russia, available to purchase here for USD 99. 1. What are the regulatory requirements for traditional, herbal, complementary,…
All about preclinical and clinical trial requirements in Russia. Prepared in association with Lidings, a leading global law firm, this is an extract from The Pharma Legal Handbook: Russia, available to purchase here for USD 99. 1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for…
An intro to the legal situation for regulatory, pricing and reimbursement in Russia. Prepared in association with Lidings, a leading global law firm, this is an extract from The Pharma Legal Handbook: Russia, available to purchase here for USD 99. 1. What are the regulatory authorities with jurisdiction over…
06/11/2018
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