portugal drug regulatory authority

Although it does not result in a direct response to users, the registered problems will be addressed by the site management team. Suspension of the right to practice if the user has a licensed profession (e.g. Egyptian Drug Authority Mission/Vision The Egyptian Drug Authority (EDA) is "an initiative for" an organization within the Ministry of Health that is responsible for safeguarding people health by regulating safety and quality of medicines (human and veterinary), biologicals, medical devices, cosmetics, dietary supplements and pesticides. Central African Republic. IB is submitted in English. Drug authorization procedures in the EU Sponsors have several options when seeking market approval for a new drug in Europe:… Sample 1. Excerto do texto â PÃ¡gina 310Lundbag, J.G. (quoted) 75 Luxembourg advisory body 251 (table) regulatory authority 251 (table) use of Community procedures 224 (table) See also BENELUX ... Cannabis is a Class B controlled drug in the UK, listed in Schedule 1 of the MDR (2001) and in the Misuse of Drugs Designation Order (2015). Clinical trials in Europe must be pre-approved by a European Competent Authority. Batch Recall Notice for Veterinary Medicine: Ketofen 10% Solution for Injection, VPA10815/051/001. The People's Bank of China. France . Ban on associating with specific other persons. China. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? The committees have a broad range of sanctions available to them when ruling on the drug use offence. It was the branch of the Government, which was the department for provision of medical services, responsible to frame the health policies and to enforce the same at a national level. The Norwegian Medicines Agency is competent authority for medical devices, and has administrative and advisory responsibilities related to legislation and supervisory authority over manufacturers, distributors and notified bodies. Excerto do texto â PÃ¡gina 1446014477 FOOD AND DRUG See also Fish and Wildlife Service ; ADMINISTRATION Land ... REVENUE SERVICE Italy , South France , South Spain , Portugal / U.S . Excerto do textoGroup 1: Countries where there is no regulatory action Holland Switzerland Portugal Francea West Germanya Group 2: Countries where regulatory authorities ... Biologics and biosimilars frequently require special handling (such as refrigeration) and processing to avoid contamination by microbes or other unwanted substances. 3 Pharmaceutical Pricing and Reimbursement. Excerto do texto â PÃ¡gina 126... National Authority for Medicines and Health Products, Portugal; ... Sanofi Pasteur, France; Dr C.K. Lee, Korea Food and Drug Administration, ... medical doctor, taxi driver) and may endanger another person or someone's possessions. All drug users can exchange used syringes at pharmacy counters across the country. United States of America. The number of drug related deaths has reduced from 131 in 2001 to 20 in 2008. 1 Abstract. 26.08.2021. Excerto do texto â PÃ¡gina 440... Federal Aviation Administration ( FAA ) has offense . Criminal penalties for trafficking in illegal assessed the government of Portugal's Civil drugs ... China Banking Regulatory Commission. Infarmed is actively engaged in regular cooperation activities particularly with Portuguese speaking countries like Brazil, Cape Verde, Mozambique and Angola and maintains a collaboration protocol with Macao. Rui Santos Ivo (President) António Faria Vaz (Vice-president) Cláudia Belo Ferreira (Member). Clever Leaves, a leading vertically-integrated licensed producer of pharmaceutical-grade medical cannabis and hemp extracts, has received a pre-license letter from INFARMED I.P., the Portuguese . 6 Successful Market Access. Thorough studies on how the various efforts have been implemented were not conducted. "The Danish Medicines Agency and other drug regulatory authorities in the EU have chosen to investigate if these rare, but serious cases could be an adverse reaction to the vaccine from . By Doaa Abouzeid 2. The national competent authorities are primarily responsible for the authorisation of medicines available in the EU that do not pass through the centralised procedure. Regulatory Authority links Jacqueline Johnson North 2020-05-18T07:05:32+01:00 . Introduction of EU Regulatory landscape. Following is the country-wise list of healthcare regulatory agencies in the world. . Ireland Health Products Regulatory Authority. According to the libertarian think tank Cato Institute, illegal drug use among Portuguese teenagers declined after 2001, and 45 percent of the country's heroin addicts sought medical treatment. We develop detailed regulatory strategies for your product, providing a clear path . Increased uptake of treatment (roughly 60% increase as of 2012. Guide to Reporting and Initial Investigation of Quality Defects in Medicinal Products for Human and Veterinary Use. The site contains information catered specifically to consumers, health professionals, and industry . The submission dossier is the packet of documents that are to be submitted to a health authority for registration of a product, or for other life-cycle maintenance activities, such as renewal of registration or CMC variations. However, the increase in numbers of drug addicts (including an "explosion" at the beginning of the 1990s), together with the growth of AIDS and hepatitis C among this population, led to a change in attitude. Step 6 If you have more information to share, please visit our, In vitro diagnostic medical devices(IVDDs) and applicable legislation, "Pharmaceuticals in Portugal: your partner in Europe", Research, evaluation and authorisation of medicines, Quality, safety and efficacy control of medicines, Good Clinical Practices (GCP's) in clinical trials, Research, assessment, registration, monitoring and supervision of health products, Clinical research evaluation, assessment and registration of CE marked medical devices, notification of health care products and market supervision activities, Licensing and inspection of pharmaceutical activity, Licensing, auditing and inspection of manufacturers, wholesalers and pharmacies ensuring the respect for the rules applicable to each operator namely Good Manufacturing Practices (GMP's), Good Distribution Practices (GDP's) and Good Pharmacy Practices (GPP's), Medicines and health products quality control, Collecting medicines and health products samples along the whole circuit and their analytical control at Infarmed's laboratory, Adverse Drug Reactions monitoring through pharmacovigilance, vigilance and monitoring of the use of health products, Collecting and evaluating Adverse Drug Reactions or any other incidents that may occur with medical devices and any other information related with the usage of medicines and health products, Supervision of the evolution of the market and promotion of the rational use of medicines including generics, Evaluation of medicines for reimbursement purposes, Evaluation of pharmaco-therapeutic and pharmaco-economic studies, Monitoring of the access and use of medicines and health products, Release of information to healthcare professionals and citizens with a view to promote the safe and rational use of medicines and other health products, Release of information for various users through the web site of Infarmed and also through specific publications (such as the Therapeutic Handbook, the National Formulary of Medicines, the Guide of Generic Medicines, the Pharmacovigilance Bulletin, Infarmed Notícias Journal distributed to all partners), The Medicines Information Blue line (800 222 444), The Information Centre on Medicines and Health Products and the Technical and Scientific Documentation Centre, Development of preventive and corrective actions on the Medicines Policy under implementation. Place EC REP name and address on Instructions for Use, outer packaging, or device label. Crimprev info n°29bis – (De)criminalisation of the use and possession of drugs (Deutschland, Italy, Spain)*", "Portugal's Drug Experience: New Study Confirms Decriminalization Was a Success", EMCDDA: Drug treatment overview: Portugal, Drug Decriminalization in Portugal: Lessons for Creating Fair and Successful Drug Policies, Drug and precursor laws by country or territory, https://en.wikipedia.org/w/index.php?title=Drug_policy_of_Portugal&oldid=1035463689, Articles needing additional references from March 2015, All articles needing additional references, Short description is different from Wikidata, Articles with unsourced statements from March 2021, Wikipedia articles in need of updating from October 2015, All Wikipedia articles in need of updating, Articles with unsourced statements from November 2019, Articles needing additional references from December 2016, Articles with unsourced statements from March 2017, Articles with Portuguese-language sources (pt), Creative Commons Attribution-ShareAlike License. ISLAMABAD: Pakistan's Drug Regulatory Authority has approved the emergency use of the Russian-made vaccine against the coronavirus disease, Gam-COVID-Vac, commonly known as Sputnik V. The . The Institute pursues its activity in several domains at national and at European levels: Infarmed carries out Portugal's tasks within the framework of the European System of Medicines namely by ensuring the representation and participation in the various evaluation and supervision bodies and activities of the European Medicines Agency (EMA), of the European Commission and of the European Network of Medicines and Health Products Authorities. Overview With a global Regulatory framework coupled with expectations to be the powerhouse destination for pharmaceutical manufacturers, Russia offers a good fortune for medicinal product manufacturers to invest in the region. Excerto do texto â PÃ¡gina 254Portugal : Instituto da FarmÃ¡cia e do Medicamento ( INFARMED ) . Finland : LÃ¤Ã¤kelaitos / LÃ¤kemedelsverket ( National Agency for Medicines ) . Singapore. The regulatory application for this modification should be submitted by October 2021. Earlsfort Terrace IRL - Dublin 2 Tel: +353 1 6764971 Fax: +353 1 6762517 Website: www.hpra.ie e-mail: medsafety@hpra.ie All three programmes finance different initiatives and projects supporting drug users through training opportunities, employment support, and/or housing. It is run by the National Commission for the Fight against AIDS - set up by the Ministry of Health and the National Association of Pharmacies - a non-governmental organisation representing the majority of Portuguese pharmacies. At programme start, a media campaign was launched by television, radio and the press, and posters were put up in discothèques and bars in order to attract the attention of the target population to the problems associated with drug addiction, in particular HIV transmission through needle-sharing. Ban on visiting certain places (e.g. [9] Even if there are no criminal penalties, these changes did not legalize drug use in Portugal. The policy consisted of multiple methods to reduce the spread of HIV, among which were: Harm reduction efforts . [2], There is little reliable information about drug use, injecting behaviour or addiction treatment in Portugal before 2001, when general population surveys commenced. CLASSIFICATION SYSTEM: Medical devices are classified according to risk into Classes I, IIa, IIb and III. Dr Zaza CHAPICHADZE, MD, Drug Regulatory Authority for Medical Activities, Georgia Dr Afonso CAVACO, then: University Lisbon, Portugal Professor Han DE GIER, University of Groningen, the Netherlands Ms Marlies GEURTS, University of Groningen, the Netherlands Dr pharm. 61. It is standard worldwide with users including United Nations, the European Commission, United States government. With the 2001 decriminalization bill, the consumer is now regarded as a patient and not as a criminal (having the amount usually used for ten days of personal use is not a punishable crime) but repression persists. 26.08.2021. The requirements vary very widely from country to country, but in general a dossier contains administrative documents, (such as… About Us. Excerto do texto â PÃ¡gina 131The National Agency for Food and Drug Administration and Control (NAFDAC), established in 1993, is the regulatory authority in Nigeria. The drug policy of Portugal called "The drug strategy", was put in place in 2000, and was legally effective from July 2001. INFARMED - National Authority of Medicines and Health Products, I.P. Portugal signed all the UN conventions on narcotics and psychotropic to date. Excerto do texto â PÃ¡gina 243AVIATION SAFETY OVERSIGHT: The U.S. Federal Aviation Administration (FAA) has assessed the ... use, or trafficking in illegal drugs in Portugal are strict, ... Freyr, as an exclusive global Regulatory partner, assists organizations to keep abreast with the Venezuelan regulatory market changes and for preparation of local dossier documentation for submissions and approvals of new registrations and authorizations. Canada - Health Canada. The European medicines regulatory system is based on a network of regulatory authorities (national competent authorities (NCA)) from the 28 European Union member states, Iceland, Norway and Liechtenstein, the European Commission and the European Medicines Agency (EMA). These figures are based on the Portuguese minimum wage of about €485 (Banco de Portugal, 2001) and translate into hours of work lost. Chile. Excerto do texto â PÃ¡gina 59... Human Drugs: Enforcement of the Post-marketing ADE Reporting Regulations'', ... from the regulatory authorities of Portugal, France and Ireland. Excerto do textoSavulescuKayser proposal could transform WADA into, in effect, a global sportsfocussed drugs and healthcare regulatory agency whose primary responsible ... The committee has the explicit power to suspend sanctions conditional upon voluntary entry into treatment. About Us. Possession has remained prohibited by Portuguese law, and criminal penalties are still applied to drug growers, dealers and traffickers. The present book focuses on developed markets with the goal of helping students, academics, industry personnel, government workers, and decision makers understand the environment in developed markets.
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