Tagged with Legal Handbook

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…

Pharma Legal Handbook 1. Are biosimilar medicines considered the same as generic medicines in your country? No, biosimilar medicines are not considered the same as generic medicines in Iraq. Generic medicines are chemically identical to their branded counterparts, while biosimilars are derived from living organisms and are similar but not identical to the…

Pharma Legal Handbook 1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? Competences for implementation and enforcement of pharmaceutical and medical devices legislation are shared between three governmental bodies: the Agency for Medicines and Medical Devices (ALIMS), which is an independent regulatory body entrusted with…

Pharma Legal Handbook 1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? No, there is no requirements for clinical trials to be conducted locally as a condition for marketing approval.   2. How are clinical trials funded? Clinical trials are funded by the sponsors.…

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? As outlined in the answer to question 3 in Chapter 1, marketing authorisation of medicinal products (including new drugs and biologics, regardless of the manner of reimbursement) may be…

Pharma Legal Handbook 1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? Traditional medicines are subject to a marketing authorization issued by ALIMS. Marketing authorization is not required for traditional herbal medicines or homoeopathic medicines which fulfil conditions prescribed in the Medicines Act. Instead, they are registered…

Pharma Legal Handbook 1. What types of liability are recognized in your jurisdiction? In Serbia, there are two parallel regimes of product of liability applicable to medicinal products. The first one is established by the Obligations Act of 1978 (as amended), while the second type is prescribed by the Consumer Protection Act of…