25/05/2021
Istanbul’s First Instance IP Court recently dismissed a negative declaratory action (the “Case”) against our client citing the plaintiff’s lack of standing because the pharmaceutical at issue was unlicensed as of the when the action was started. The ruling is noteworthy because it appears to confirm the precedential force of similar Court of Appeal decisions. For pharmaceuticals in particular, negative declaratory relief is considered as an effective market-clearing tool. Anyone with an interest in a pharmaceutical product sufficient to…
27/04/2021
The key facts about regulatory reforms in the UAE. Prepared in association with STA, a leading law firm in the UAE, this is an extract from The Pharma Legal Handbook: UAE, available to purchase here for GBP 75. 1. Are there proposals for reform or significant change to the healthcare system? On 19 December 2019, the UAE government adopted a new federal law which was to overhaul Law No. 4 of 1983 on the Pharmacy Professional and Pharmaceutical Establishments…
The key facts about patents & trademarks in the UAE. Prepared in association with STA, a leading law firm in the UAE, this is an extract from The Pharma Legal Handbook: UAE, available to purchase here for GBP 75. 1. What are the basic requirements to obtain patent and trademark protection? In the United Arab Emirates, patents are granted if the applications meet the criteria of Novelty, Inventive Concept (also known as Non-obviousness) and Industrial applicability. 2. What…
The key facts about product liability in the UAE. Prepared in association with STA, a leading law firm in the UAE, this is an extract from The Pharma Legal Handbook: UAE, available to purchase here for GBP 75. 1. What types of liability are recognized in your jurisdiction? In the UAE, Federal Law No. 24 of 2006 on Consumer Protection (Consumer Protection Law), as amended by Federal Law No. 7 of 2011, is the main piece of legislation relating…
The ins and outs of traditional medicines and OTC products in the UAE. Prepared in association with STA, a leading law firm in the UAE, this is an extract from The Pharma Legal Handbook: UAE, available to purchase here for GBP 75. 1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? As per Article 1 of the Pharmacy Law of 1983, medicines are defined as “any medicine that contains one or more element…
26/04/2021
The key facts about marketing, manufacturing, packaging & labeling, advertising in the UAE. Prepared in association with STA, an international law firm, this is an extract from The Pharma Legal Handbook: UAE, available to purchase here for GBP 75. 1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products? Under the Pharmaceutical Law, all applications for marketing authorization must be made through the Ministry of Health (MOH). The authorization…
All legal aspects surrounding preclinical and clinical trial requirements in the UAE. Prepared in association with STA, an international law firm, this is an extract from The Pharma Legal Handbook: UAE, available to purchase here for GBP 75. 1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? It is not an established requirement to conduct the clinical trials for products locally. As previously established, clinical trials are only required when the…
An insight into regulatory, pricing and reimbursement overview in the UAE. Prepared in association with STA, an international law firm, this is an extract from The Pharma Legal Handbook: UAE, 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 UAE Ministry of Health (MOH) is the primary authority responsible for oversight of all the regulatory functions concerning pharmaceuticals in the UAE. The Ministry…
06/04/2021
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 the current situation. CE Certificate Requirement in Turkey The Regulation on CE Marking, published in the Official Gazette on, and effective as of, 23 February 2012 (the “Regulation”) governs…
11/06/2020
Drugs, biologicals and medical devices authorization fees are fixed as part of Finance Law in Algeria. Fees are payable by the person who makes the application or submits variations, in local currency for locally-manufactured products, and in convertible foreign currencies for imported ones. The supplementary Finance Law for 2020 has just been published in the Official Gazette. Its Article 61 has modified authorization fee due for a new application related to imported and non-essential drugs and biologics. As…
In Algeria, the supplementary Finance Law for 2020 has just been published in the Official Gazette. This law materializes the authorities’ will to significantly ease the control of foreign investments in order to boost Foreign Direct Investment (FDI) and to accelerate the diversification of the national economy. Despite several competitive advantages, including low cost of energy, skilled and inexpensive workforce, and geographic location at the crossroads of Europe, Africa, and the Middle East, FDI flows into Algeria have remained…
25/05/2020
The ongoing reform of pharmaceutical regulations in Algeria has been marked on January 2020 by publication in the Official Gazette of the long-awaited Decree No 19-379 dated of 31st December 2019. This Decree has laid down procedures for specific administrative, technical and safety control of substances and drugs with psychotropic properties (i.e. including Cannabinoids). The Decree No 19-379 was initially planned to enter into force by 5th of April 2020 according to its Article 41, but considering COVID-19 pandemic…
12/05/2020
The COVID-19 pandemic continues to spread rapidly across the globe amid critical supply shortages of medical devices and medicines. The rapid spread of the virus, on the one hand, threatens supply chains and causes shortages, on the other hand, it also strengthens global solidarity. Brands from different sectors make an effort towards helping in the fight against the pandemic. Fashion brands are manufacturing masks, luxury cosmetic brands are supporting disinfectant manufactures, the entrepreneur ecosystem swept into seeking alternative ways to…
04/02/2020
Keen to learn more about regulatory reform in Zimbabwe? Read on! Prepared in association with Honey & Blanckenberg, a leading law firm in Zimbabwe, this is an extract from The Pharma Legal Handbook: Zimbabwe, available to purchase here for USD 99. 1. Are there proposals for reform or significant change to the healthcare system? Currently, there is no proposal for reform in the form of proposed or draft legislation. The last major proposal for reform was the Public Health…
A brief overview of the situation regarding patents & trademarks in Zimbabwe. Prepared in association with Honey & Blanckenberg, a leading law firm in Zimbabwe, this is an extract from The Pharma Legal Handbook: Zimbabwe, available to purchase here for USD 99. 1. What are the basic requirements to obtain patent and trademark protection? Patent Protection The Patents Act [Chapter 26:03], provides that in order to qualify for patent protection, an invention must consist of patentable subject matter and…
An intro to the legal situation for product liability in Zimbabwe. Prepared in association with Honey & Blanckenberg, a leading law firm in Zimbabwe, this is an extract from The Pharma Legal Handbook: Zimbabwe, available to purchase here for USD 99. 1. What types of liability are recognized in your jurisdiction? Zimbabwe has recently passed a Consumer Protection Act [Chapter 14:14] (“the CPA”), which was gazetted on 10 December 2019. In addition, the common law concept of delict law…
The ins and outs of traditional medicines and OTC products in Zimbabwe. Prepared in association with Honey & Blanckenberg, a leading law firm in Zimbabwe, this is an extract from The Pharma Legal Handbook: Zimbabwe, available to purchase here for USD 99. 1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? The regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices as per the Medicines and Allied Substances Control (Complementary Medicines)…
Marketing, manufacturing, packaging & labeling, advertising in Zimbabwe – an overview. Prepared in association with Honey & Blanckenberg, a leading law firm in Zimbabwe, this is an extract from The Pharma Legal Handbook: Zimbabwe, 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 process is set out in the Medicines Control Authority of Zimbabwe (Guidelines on Submission of Documentation…
All legal aspects surrounding preclinical and clinical trial requirements in Zimbabwe. Prepared in association with Honey & Blanckenberg, a leading law firm in Zimbabwe, this is an extract from The Pharma Legal Handbook: Zimbabwe, available to purchase here for USD 99. 1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? There is no such requirement. The Medicines and Allied Substances Control Act only requires that a medicine be registered. In…
The key facts about regulatory, pricing and reimbursement overview in Zimbabwe. Prepared in association with Honey & Blanckenberg, a leading law firm in Zimbabwe, this is an extract from The Pharma Legal Handbook: Zimbabwe, available to purchase here for USD 99. 1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? The Medicines Control Authority of Zimbabwe (MCAZ) is the authority tasked with regulation of drugs and medical devices in Zimbabwe. It…
31/01/2020
The low-down on the situation regarding biosimilars & biologics in Turkey. Prepared in association with Moroğlu Arseven, a leading Turkish law firm, this is an extract from The Pharma Legal Handbook: Turkey, available to purchase here for GBP 75. 1. Are biosimilar medicines considered the same as generic medicines in your country? Generic medicines include identical molecules with the original reference product, and these molecules are small and chemically stable molecules produced through chemical synthesis. However, biosimilar is the name…
The ins and outs of localization in Turkey. Prepared in association with Moroğlu Arseven, a leading Turkish law firm, this is an extract from The Pharma Legal Handbook: Turkey, available to purchase here for GBP 75. 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 is a developing and ongoing plan in Turkey. Increasing employment, attracting foreign investment, and maintaining the quality reached…
Keen to learn more about orphan drugs & rare diseases in Turkey? Read on! Prepared in association with Moroğlu Arseven, a leading Turkish law firm, this is an extract from The Pharma Legal Handbook: Turkey, available to purchase here for GBP 75. 1. What is the definition of Rare Diseases in your country? There is no definition of rare diseases in Turkey. 2. Does the designation of ‘Orphan Drug’ exist in your country? (Does it correspond with the definition…
23/01/2020
Biosimilars & biologics in Egypt – a legal guide. Prepared in association with Youssry Saleh Law Firm, a leading global law firm, this is an extract from The Pharma Legal Handbook: Egypt, available to purchase here for GBP 75. 1. Are biosimilar medicines considered the same as generic medicines in your country? In Egypt, Biosimilars are considered different from Generic Medicines but similar to biological products, where the “Biosimilar” definition according to the Guidelines for Registration of biosimilar products…
The key facts about the localization in Egypt. Prepared in association with Youssry Saleh Law Firm, a leading global law firm, this is an extract from The Pharma Legal Handbook: Egypt, available to purchase here for GBP 75. 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? Yes, the legal framework of localization is regulated through Ministerial Decree No. 425 of the year…
All legal aspects surrounding orphan drugs & rare diseases in Egypt. Prepared in association with Youssry Saleh Law Firm, a leading global law firm, this is an extract from The Pharma Legal Handbook: Egypt, available to purchase here for GBP 75. 1. What is the definition of Rare Diseases in your country? In Egypt, there is no definition of the “Rare Diseases” however, in accordance with the conclusion of medicine professors’ researches and studies a disease is considered a…
Cannabinoid drugs, medicinal cannabis and opioid drugs in Egypt – an overview. Prepared in association with Youssry Saleh Law Firm, a leading global law firm, this is an extract from The Pharma Legal Handbook: Egypt, available to purchase here for GBP 75. Cannabinoid Drugs 1. Are Cannabinoid Drugs authorized in your country? No, Cannabinoid Drugs are not authorized in Egypt, however, they are regulated by Law No. 182 of the year 1960 concerning combating drugs and regulating their use…
20/01/2020
A brief overview of the situation regarding biosimilars and biologics. Prepared in association with SAARPE Association, a leading law firm in Algeria, this is an extract from The Pharma Legal Handbook: Algeria, available to purchase here for USD 99. 1. Are biosimilar medicines considered the same as generic medicines in your country? The Health Law No 18-11, dated of 2 July 2018 and published in the Official Gazette, has made a clear distinction between similar biotherapeutic products and generic…
The ins and outs of localization in Algeria. Prepared in association with SAARPE Association, a leading law firm in Algeria, this is an extract from The Pharma Legal Handbook: Algeria, available to purchase here for USD 99. 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? According to Article 206 of Health law No 18-11, dated of 2 July 2018 and published in…
19/01/2020
A brief overview of the situation regarding orphan drugs and rare diseases in Algeria. Prepared in association with SAARPE Association, a leading law firm in Algeria, this is an extract from The Pharma Legal Handbook: Algeria, available to purchase here for USD 99. 1. What is the definition of Rare Diseases in your country? Rare diseases are defined in Algeria as those listed in the Ministerial Decree, dated of 6 February 2013 and published in the Official Gazette, fixing…
Key legal info on cannabinoid drugs, medicinal cannabis and opioid drugs in Algeria. Prepared in association with SAARPE Association, a leading law firm in Algeria, this is an extract from The Pharma Legal Handbook: Algeria, available to purchase here for USD 99. Cannabinoid Drugs 1. Are Cannabinoid Drugs authorized in your country? Cannabinoid drugs, i.e. drug products as defined in Article 208 of Health Law No 18-11, dated of 2 July 2018, where the active substance is cannabinoids, can…
Regulatory reforms in Algerian Pharma – a comprehensive legal overview. Prepared in association with SAARPE Association, a leading law firm in Algeria, this is an extract from The Pharma Legal Handbook: Algeria, available to purchase here for USD 99. 1. Are there proposals for reform or significant change to the healthcare system? Yes, there is an important reform that is ongoing and which concerns the authority in charge of regulating drugs, biologicals and medical devices for human use at…
Want to know more about patents & trademarks in Algerian Pharma? Read on! Prepared in association with SAARPE Association, a leading law firm in Algeria, this is an extract from The Pharma Legal Handbook: Algeria, available to purchase here for USD 99. 1. What are the basic requirements to obtain patent and trademark protection? Patents Ordinance No 03-07 and Trademarks Ordinance No 03-06, both dated of 19 July 2003 and published in the Official Gazette, form the legislative framework…
The key facts about product liability in Algerian Pharma. Prepared in association with SAARPE Association, a leading law firm in Algeria, this is an extract from The Pharma Legal Handbook: Algeria, available to purchase here for USD 99. 1. What types of liability are recognized in your jurisdiction? In Algeria, any product intended for consumption and/or use, under normal or reasonably foreseeable conditions of use, including of duration, must present no risk or only reduced risks at a low…
All legal aspects surrounding traditional medicines and OTC products in Algeria. Prepared in association with SAARPE Association, a leading law firm in Algeria, this is an extract from The Pharma Legal Handbook: Algeria, available to purchase here for USD 99. 1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? Traditional, herbal and complementary products are commonly regulated by Ministry of Commerce under provisions of Consumer Protection and Fraud Repression Law No 09-03 dated…
Marketing, manufacturing, packaging & labeling, advertising in Algerian Pharma – an overview. Prepared in association with SAARPE Association, a leading law firm in Algeria, this is an extract from The Pharma Legal Handbook: Algeria, 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? To obtain market authorization for new drugs, biologics and medical devices in Algeria, submission of application to…
The legal framework for preclinical and clinical trial requirements in Algeria. Prepared in association with SAARPE Association, a leading law firm in Algeria, this is an extract from The Pharma Legal Handbook: Algeria, available to purchase here for USD 99. 1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? The Health Law No 18-11, dated of 2 July 2018, replacing Health Protection and Promotion Law No 85-05, dated of 16…
An insight into regulatory, pricing and reimbursement in Algeria. Prepared in association with SAARPE Association, a leading law firm in Algeria, this is an extract from The Pharma Legal Handbook: Algeria, available to purchase here for USD 99. 1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? Ministry of Health, Population and Hospital Reform (“MSPRH” – “Ministère de la Santé, de la Population et de la Réforme Hospitalière”) is the national…
07/11/2019
Key legal info on cannabinoid drugs, medicinal cannabis and opioid drugs in Nigeria. 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. Cannabinoid Drugs 1. Are Cannabinoid Drugs authorized in your country? Generally, in Nigeria, it is an offence to manufacture, sell, possess, import, export or otherwise deal in cannabinoid drugs without an appropriate license. Cannabinoid drugs may however be used…
Regulatory reforms in Nigerian Pharma – a comprehensive legal overview. 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. Are there proposals for reform or significant change to the healthcare system? There are currently various bills before the National Assembly (legislative arm in Nigeria) for the repeal and re-enactment of the extant National Health Insurance Scheme Act, which provides for…
Want to know more about patents & trademarks in Nigerian Pharma? Read on! 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 basic requirements to obtain patent and trademark protection? Patents and Trademarks are afforded Intellectual Property (IP) protection under Nigerian law. IP as defined by the World Intellectual Property Organization (WIPO) refers to the creations of…
A brief overview of the situation regarding product liability 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 types of liability are recognized in your jurisdiction? In Nigeria, liability may arise from a breach of an obligation implied in law, from a breach of contract in which case a contractual liability will be imposed and from…
06/11/2019
The low-down on the situation regarding traditional medicines and OTC products 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 requirements for traditional, herbal, complementary, or alternative medicines and devices? Herbal medicines and related products are products that contain exclusively active ingredients of one or more herbal substances or one or more herbal…
The legal framework for marketing, manufacturing, packaging & labeling, advertising 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 is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products? NAFDAC is the body responsible for regulating and controlling the manufacture, importation, exportation, advertisement, distribution, sale and use…
All legal aspects surrounding preclinical and clinical trial requirements 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. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? Clinical trials are not required in all cases, clinical trials will be required to be conducted as a condition for marketing approval…
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 over drugs, biologicals, and medical devices in your country? The regulatory authorities with jurisdiction over drugs, biologicals and medical devices in Nigeria are: (i) The National Agency for Food and…
28/06/2019
An intro to the legal situation for regulatory reforms in Egypt. Prepared in association with Youssry Saleh Law Firm, a leading global law firm, this is an extract from The Pharma Legal Handbook: Egypt, available to purchase here for GBP 75. 1. Are there proposals for reform or significant change to the healthcare system? No, but the Comprehensive Health Insurance Scheme Law No. 2 of the year 2018 was issued on 11th of January 2018 and its Executive Regulations…
Patents and trademarks in Egypt – a comprehensive legal overview. Prepared in association with Youssry Saleh Law Firm, a leading global law firm, this is an extract from The Pharma Legal Handbook: Egypt, available to purchase here for GBP 75. 1. What are the basic requirements to obtain patent and trademark protection? In accordance to the Executive Regulations provided in the Decree No. 1366 of the year 2003, the requirements to obtain patents are as follows: Fill the application…
The key facts about product liability in Egypt. Prepared in association with Youssry Saleh Law Firm, a leading global law firm, this is an extract from The Pharma Legal Handbook: Egypt, available to purchase here for GBP 75. 1. What types of liability are recognized in your jurisdiction? There are two types of liabilities in Egypt, Criminal Liability, in case the product caused any injury, permanent disability injury or wrongful death due to negligence or mistake occurred in the…
A brief overview of the situation regarding traditional medicines and OTC products in Egypt. Prepared in association with Youssry Saleh Law Firm, a leading global law firm, this is an extract from The Pharma Legal Handbook: Egypt, available to purchase here for GBP 75. 1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? The regulatory requirements for traditional and herbal products shall follow the regulations and standards: WHO requirements and guidelines; Good Manufacturing…
All legal aspects surrounding marketing, manufacturing, packaging & labeling, and advertising in Egypt. Prepared in association with Youssry Saleh Law Firm, a leading global law firm, this is an extract from The Pharma Legal Handbook: Egypt, available to purchase here for GBP 75. 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 of marketing new drugs and any medicinal products are as follows:…
Preclinical and clinical trial requirements in Egypt – an overview. Prepared in association with Youssry Saleh Law Firm, a leading global law firm, this is an extract from The Pharma Legal Handbook: Egypt, available to purchase here for GBP 75. 1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? Yes, as there is an Authority “Central Directorate for Research and Health Development”, which is responsible for the registration and approvals…
An insight into regulatory, pricing, and reimbursement of drugs in Egypt. Prepared in association with Youssry Saleh Law Firm, a leading global law firm, this is an extract from The Pharma Legal Handbook: Egypt, 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 pharmaceutical regulatory body in Egypt is the Egyptian Drug Authority (EDA) operating and working under supervision of the Ministry of…
06/11/2018
The legal framework for regulatory reforms in Turkey. Prepared in association with Moroğlu Arseven, a leading Turkish law firm, this is an extract from The Pharma Legal Handbook: Turkey, available to purchase here for GBP 75. 1. Are there proposals for reform or significant change to the healthcare system? No proposals for reform exist or are expected in the short term. However, minor amendments of existing laws and regulations may occur. The Draft Regulation on the Registration, Surveillance and Tracking…
Patents and trademarks in Turkey – an overview. Prepared in association with Moroğlu Arseven, a leading Turkish law firm, this is an extract from The Pharma Legal Handbook: Turkey, available to purchase here for GBP 75. 1. What are the basic requirements to obtain patent and trademark protection? Both patents and trademarks are regulated under the Industrial Property Rights Law numbered 6769 entered into force on 10 January 2017 (“IP Law”). Any sign, including words, shapes, colours, letters, numbers,…
An insight about product liability in Turkish Pharma. Prepared in association with Moroğlu Arseven, a leading Turkish law firm, this is an extract from The Pharma Legal Handbook: Turkey, available to purchase here for GBP 75. 1. What types of liability are recognized in your jurisdiction? Medicinal product liability arises from the Code of Obligations as tort liability and contractual liability, as well as from the Consumer Protection Law. To claim under tort law, the claimant must prove the existence…
The lowdown on the situation regarding traditional medicines and OTC products in Turkey. Prepared in association with Moroğlu Arseven, a leading Turkish law firm, this is an extract from The Pharma Legal Handbook: Turkey, available to purchase here for GBP 75. 1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? Traditional herbal medicinal products are pharmaceutical preparations which have specific indications for use, which are specifically administered according to the specified dose and posology,…
Hot-button legal issues around marketing, manufacturing, packaging & labelling and advertising in Turkish pharma. Prepared in association with Moroğlu Arseven, a leading Turkish law firm, this is an extract from The Pharma Legal Handbook: Turkey, available to purchase here for GBP 75. 1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products? Under Turkish laws and regulations, a registration process is required for a drug, biologic medicinal product, over-the-counter medications…
Preclinical and clinical trial requirements in Turkey – a legal guide. Prepared in association with Moroğlu Arseven, a leading Turkish law firm, this is an extract from The Pharma Legal Handbook: Turkey, available to purchase here for GBP 75. 1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? Clinical trials for drugs are regulated by the Regulation on Clinical Trials of Drugs and Biological Products. Clinical trials for medical devices are regulated…
An intro to the legal situation for regulatory, pricing and reimbursement in Turkey. Prepared in association with Moroğlu Arseven, a leading Turkish law firm, this is an extract from The Pharma Legal Handbook: Turkey, available to purchase here for GBP 75. 1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? Turkey’s Ministry of Health (“Ministry”) is the main regulatory and responsible authority for drugs, biologicals and medical devices. Regulatory authorities with jurisdiction…
12/10/2018
Structured legal guide to cannabinoid drugs, medicinal cannabis and opioid drugs in South Africa. Prepared in association with Fasken, a leading global law firm, this is an extract from The Pharma Legal Handbook: South Africa, available to purchase here for USD 99. CANNABINOID DRUGS 1. Are Cannabinoid Drugs authorized in your country? Cannabis use is illegal in most countries and until recently this included South Africa. In terms of the Drugs and Drug Trafficking Act (“the Drugs Act”) it is…
Regulatory reforms in South African Pharma – a comprehensive legal overview. Prepared in association with Fasken, a leading global law firm, this is an extract from The Pharma Legal Handbook: South Africa, available to purchase here for USD 99. 1. Are there proposals for reform or significant change to the healthcare system? NATIONAL HEALTH INSURANCE BILL AND MEDICAL SCHEMES AMENDMENT BILL On 21 June 2018 the Minister of Health Published the Medical Schemes Amendment Bill and the National Health Insurance…
The ins and outs of patents and trademarks in South African Pharma. Prepared in association with Fasken, a leading global law firm, this is an extract from The Pharma Legal Handbook: South Africa, available to purchase here for USD 99. 1. What are the basic requirements to obtain patent and trademark protection? Patents and Trademarks form part of Intellectual property in terms of South African law, where Intellectual Property is defined as: “a generic term used to refer collectively to…
The key facts about product liability in South African Pharma. Prepared in association with Fasken, a leading global law firm, this is an extract from The Pharma Legal Handbook: South Africa, available to purchase here for USD 99. 1. What types of liability are recognized in your jurisdiction? In terms of South African common law legal liability may arise from a breach of contract or from delict. Liability in delict may arise irrespective of the existence of a contract…
Traditional medicines & OTC products in South Africa – a legal guide. Prepared in association with Fasken, a leading global law firm, this is an extract from The Pharma Legal Handbook: South Africa, available to purchase here for USD 99. 1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? In terms of the Medicines Act medication is classified into 4 categories from Category A- Category D depending on the In terms of the…
All legal aspects of marketing, manufacturing, packaging, labeling and advertising of drugs in South Africa. Prepared in association with Fasken, a leading global law firm, this is an extract from The Pharma Legal Handbook: South Africa, 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? MARKETING OF MEDICINES AND MEDICAL DEVICES OR IVDS: Marketing of medicines are regulated by Section…
All about preclinical & clinical trial requirements in South Africa. Prepared in association with Fasken, a leading global law firm, this is an extract from The Pharma Legal Handbook: South Africa, available to purchase here for USD 99. 1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? No. Clinical Trials do not have to be conducted locally in order for the Regulator to register the product and market approval to…
An insight into regulatory, pricing and reimbursement in South African Pharma. Prepared in association with Fasken, a leading global law firm, this is an extract from The Pharma Legal Handbook: South Africa, available to purchase here for USD 99. 1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? The South African Health Products Regulatory Authority (SAHPRA), previously known as the Medicine and Control Council (MCC). 2. What is the regulatory…
The ins and outs of localization in Turkey. Prepared in…
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