Tagged with M

Italy The latest Italy Pharma News, including the government’s decision to make COVID-19 vaccines mandatory for all healthcare workers, the manufacturing of Sputnik V, and recent updates from the country’s top companies, including Chiesi, Angelini Pharma and Menarini.   Doses of Russia’s Sputnik V, made in Italy, to go on sale…

France While Big Pharma companies like Pfizer, Janssen and AstraZeneca, have grabbed the headlines over the past year for their work on COVID-19 vaccines, smaller and  lesser-known companies are also playing a crucial role in the development of both large companies’ candidates and their own self-developed shots.   At the onset…

Russia The latest Russia Pharma News, including Biocad’s ramping up of Sputnik V COVID-19 vaccine manufacturing, Geropharm’s deal to produce insulin in Venezuela, the bypassing of Gilead’s Remdesivir IP, and the Russian government’s decision to delay approvals of Chinese vaccines in favor of local shots.   Russian Biocad plans to produce…

Turkey The shockwaves from the UK’s exit from the European Union have resounded across the continent, including in Turkey, where the country’s pharmaceutical and medical devices regulator has had to adjust its guidance on CE-mark certified devices. Leading lawyers from top Turkish law firm and PharmaBoardroom legal partner Moroğlu Arseven explain…

Pharma Legal Handbook Key legal info on regulatory, pricing and reimbursement in Bulgaria. Prepared in association with Kinstellar and PharmDedict, this is an extract from The Pharma Legal Handbook: Bulgaria, available to purchase here for GBP 75.   1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? The following…

Pharma Legal Handbook The ins and outs of preclinical & clinical trial requirements: Bulgaria. Prepared in association with Kinstellar and PharmDedict, this is an extract from The Pharma Legal Handbook: Bulgaria, available to purchase here for GBP 75.   1. Are clinical trials required to be conducted locally as a condition (stated or…

Pharma Legal Handbook Marketing, manufacturing, packaging & labeling, advertising in Bulgaria – a comprehensive legal overview. Prepared in association with Kinstellar and PharmDedict, this is an extract from The Pharma Legal Handbook: Bulgaria, available to purchase here for GBP 75.   1. What is the authorisation process for the marketing of new drugs, biologics, medical devices, over-the-counter medications,…

Pharma Legal Handbook The key facts about traditional medicines and OTC products in Bulgarian Pharma. Prepared in association with Kinstellar and PharmDedict, this is an extract from The Pharma Legal Handbook: Bulgaria, available to purchase here for GBP 75.   1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines…

Pharma Legal Handbook All legal aspects surrounding product liability in Bulgaria. Prepared in association with Kinstellar and PharmDedict, this is an extract from The Pharma Legal Handbook: Bulgaria, available to purchase here for GBP 75.   1. What types of liability are recognized in your jurisdiction? There are three types of liability recognised…

Pharma Legal Handbook A brief overview of the situation regarding patents and trademarks in Bulgaria. Prepared in association with Kinstellar and PharmDedict, this is an extract from The Pharma Legal Handbook: Bulgaria, available to purchase here for GBP 75.   1. What are the basic requirements to obtain patent and trademark protection? A)…

Pharma Legal Handbook The low-down on the situation regarding regulatory reforms in Bulgaria. Prepared in association with Kinstellar and PharmDedict, this is an extract from The Pharma Legal Handbook: Bulgaria, available to purchase here for GBP 75.   1. Are there proposals for reform or significant change to the healthcare system? The topic…

Pharma Legal Handbook The key facts about the cannabinoids drugs in Bulgaria. Prepared in association with Kinstellar and PharmDedict, this is an extract from The Pharma Legal Handbook: Bulgaria, available to purchase here for GBP 75.   Cannabinoid Drugs 1. Are Cannabinoid Drugs authorized in your country? Pursuant to the Narcotic Substances and…