Tagged with Legal Handbook

Pharma Legal Handbook 1. What is the definition of Rare Diseases in your country? Our law states a specific definition for rare diseases, which is the following: They are mainly considered life-threatening or debilitating in the long term. They have low prevalence and high complexity and constitute many diseases. They are characterized by…

Pharma Legal Handbook 1. Are there any rules or regulations requiring and/or encouraging localization in your country? What is the legal framework defining these localization rules and policies? New productive investments made from January 2022, including those in the pharmaceutical sector, may be eligible for tax benefits. Investors generally benefit from a 3-point…

Pharma Legal Handbook 1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? The regulatory authority responsible for drugs, biologicals, and medical devices in Iraq is the Ministry of Health “MoH”. There is a dedicated body within the MoH known as the Iraq Drug Regulatory Authority…

Pharma Legal Handbook 1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? In Iraq, it is not always explicitly required that the clinical trials be conducted locally for marketing approval. However, if local data are requested, companies must comply with these requirements. Local clinical…

Pharma Legal Handbook 1. What is the authorization process for the marketing of new drugs, biologics, medical devices, non-prescription medications, and other medicinal products? In Iraq, the authorization process for marketing new drugs, biologics, medical devices, over-the-counter “OTC” medications, and other medicinal products is managed by Iraq Drug Regulatory Authority “IDRA” at Ministry…

Pharma Legal Handbook 1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? Traditional, herbal, complementary, or alternative medicines and devices in Iraq are subjected to the regulations of Iraq Drug Regulatory Authority “IDRA” under the Ministry of Health “MoH”. Manufacturers or importers of these products must ensure…

Pharma Legal Handbook 1. What types of liability are recognized in your jurisdiction? Iraq recognizes several types of liability, including: Product Liability: Relating to harm caused by defective products. Tort Liability: Involving personal injury or property damage due to negligence or other wrongful acts. Contractual Liability: Stemming from breach of contract or warranty.…

Pharma Legal Handbook 1. What are the basic requirements to obtain patent and trademark protection? Patent: To obtain a patent, the invention must be new (novel), involve an inventive step (non-obvious), and be capable of industrial application. In Iraq, the invention must be disclosed in a clear and complete manner. Trademark: To obtain…

Pharma Legal Handbook 1. Are there proposals for reform or significant change to the healthcare system? Iraq has faced considerable challenges in its healthcare system due to years of conflict, instability, and underinvestment. As a result, there are ongoing discussions and proposals aimed at reforming the healthcare system to improve its quality, accessibility,…

Pharma Legal Handbook Cannabinoid Drugs 1. Are Cannabinoid Drugs authorized in your country? In Iraq, Cannabinoid Drugs are generally not authorized due to strict drug control laws and cultural sensitivities around cannabis-related substances.   2. What are the regulatory authorities with jurisdiction over Cannabinoid Drugs? The Ministry of Health and related drug regulatory…

Pharma Legal Handbook 1. Are there any rules or regulations requiring and/or encouraging localization in your country? What is the legal framework defining these localization rules and policies? Localization policies in Iraq generally aim to encourage local production, increase employment, and reduce dependence on imported goods. These rules and regulations may not be…

Pharma Legal Handbook 1. What is the definition of Rare Diseases in your country? In Iraq, there is no specific definition of rare diseases in the legal or regulatory framework. The concept of rare diseases generally refers to conditions affecting a small percentage of the population, but an official definition may be absent…