Tagged with Legal Handbook

Pharma Legal Handbook The key facts about regulation, pricing and reimbursement in Nigerian Pharma. Prepared in association with Olaniwun Ajayi LP, a leading law firm in Nigeria, this is an extract from The Pharma Legal Handbook: Nigeria, available to purchase here for USD 99.   1. What are the regulatory authorities with jurisdiction…

Pharma Legal Handbook A brief overview of the situation regarding localization in Ecuadorian pharma. Prepared in association with Corral Rosales, a leading global law firm, this is an extract from The Pharma Legal Handbook: Ecuador, available to purchase here for GBP 75.   1. Are there any rules or regulations requiring and/or encouraging…

Pharma Legal Handbook The key facts about orphan drugs and rare diseases in Ecuadorian pharma. Prepared in association with Corral Rosales, a leading global law firm, this is an extract from The Pharma Legal Handbook: Ecuador, available to purchase here for GBP 75.   1. What is the definition of Rare Diseases in…

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 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 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 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 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 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 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 legal framework for cannabinoid drugs, medicinal cannabis and opioid drugs in Ukraine. Prepared in association with Sayenko Kharenko, a leading law firm in Ukraine, this is an extract from The Pharma Legal Handbook: Ukraine, available to purchase here for USD 99.   Cannabinoid Drugs 1. Are Cannabinoid Drugs authorized in…

Pharma Legal Handbook Regulatory reforms in Greece – a comprehensive legal overview. Prepared in association with Calavros Law Firm, a leading global law firm, this is an extract from The Pharma Legal Handbook: Greece, available to purchase here for USD 99.   1. Are there proposals for reform or significant change to the healthcare system? A.…