row countries regulatory requirements

Aligning the regulatory strategy across many countries saves time and money for drug developers, resulting in earlier access by patients. Although the requirements are harmonized in regulated countries by CTD (Common technical document) filing, yet others have enormous 2Pharmaceutical Drug Regulatory Affairs Division, JSS College of Pharmacy,Udhagamandalam -643001, Tamilnadu, India. Arabia and UAE) are regulatory authorities for the regional ABSTRACT Pharmaceutical product registration is a demanding task in regulated, semi regulated and rest of world countries. ( Log Out /  (in Spanish), Ministry of Health (in Spanish) Pharmacovigilance (PV or PhV), also known as drug safety, is the pharmacological science relating to the collection, detection, assessment, monitoring, and prevention of adverse effects with pharmaceutical products. Office of Pharmacy and Medicines (in French), Ministry of Health and Social Development (in Spanish), Ministry of Labor, Health and Social Protection, http://www.who.int/medicines/areas/quality_safety/regulation_legislation/ListMRAWebsites.pdf. Thanks all. Change ). Aligning the regulatory strategy across many countries saves time and money for drug developers, resulting in earlier access by patients. Ministry of Health – Pharmaceutical Services Division, Health Sciences Authority Improved access to medicines in all countries. You have remained in right site to begin getting this info. ( Log Out /  Acces PDF Regulatory Requirements Of Medical Devices In Mena Countriesmena countries now is not type of inspiring means. Freebook Sifter is a no-frills free kindle book website that lists hundreds of thousands of books that link to Amazon, Barnes & Noble, Kobo, and REGULATORY REQUIREMENTS IN RoW COUNTRIES • Key function of RA: 1. Specific Country Requirements for Medical Device Registration in Europe: CE Marking (Conformité Européene) / CB Scheme: 4: Jun 22, 2012: M: 7.4.1.1 Statutory & Regulatory Conformity: Legal Requirements of which Country? The role of regulatory authorities is to ensure the quality, safety, and efficacy of all medicines in circulation in their country. This network is what makes the EU regulatory system unique. This is why you remain in the best website … Contribute to incorporate prioritised RoW regulatory requirements in Ambu's products and processes enabling compliance to relevant national regulatory requirements; Due to a high level of collaboration with internal stakeholders, a high level of adaptability is required. This is Page 1/9. Jagadguru Sri Shivarathreeshwara University, Mysore Abstract: In the Current scenario, different countries have to follow different regulatory requirements for marketing authorization application (MAA) approval of new drug. Regulation of drug manufacturing, importation and … The Mutual Recognition Agreement (MRA) between FDA and European Union allows drug inspectors to rely upon information from drug inspections conducted within each other’s borders. The questionnaire, which will be sent to a selected number of countries in different rounds, will facilitate the The European Banking Authority (EBA) published today a questionnaire to guide its assessment of non-EU countries’ equivalence with the EU prudential supervision and regulatory requirements specified in the Capital Requirements Regulation (CRR) and Directive (CRD). This article presents a comparison of legal and regulatory frameworks for the regulation of medicines in EAC partner states. thesis examines the regulatory requirements for medical devices in Argentina, Australia, Brazil, Canada, India, Japan, Mexico, Russia, South Korea and Taiwan and compares them with the requirements in the European Union. Good morning everyone, How many countries make up ROW? Good morning everyone, How many countries make up ROW? I'd really appreciate an answer! 5. Key Market Brazil Mexico Key Drivers Argentina Venezuela Chile Colombia Peru Cuba 32, No. Regulatory agencies of individual countries: Every country has its own agency to control health care products in their countries. Fill in your details below or click an icon to log in: You are commenting using your WordPress.com account. The country accounts for an estimated 10% of global production and 2% of world markets in pharmaceuticals. countries Regulatory requirements overview M.R.Syam Sundar Director, Global Regulatory Affairs 30thSep 2011. ( Log Out /  It is called the drug master file of Common technical document (CTD). Central Drug Standards Control Organisation Read PDF Regulatory Requirements Of Medical Devices In Mena Countries Regulatory Requirements Of Medical Devices In Mena Countries Yeah, reviewing a book regulatory requirements of medical devices in mena countries could build up your near contacts listings. Global Regulatory Requirements for Medical Devices Regulatory Affairs. Therefore it is challenging for the companies to develop a single drug which can be simultaneously submitted in various countries for approval. National Institute for the Control of Pharmaceutical and Biological Products, Central Drug Standards Control Organisation, Ministry of Health – Pharmaceutical Services Division, Federal Commission for Protection against Health Risks, Ministry of Health and Social Development, Sprout Pharmaceuticals Receives FDA Approval of ADDYI™ (Flibanserin 100 MG), Ask a Question to State Medicines Control Agency of Lithuania, FDA Provides New Guidance on Submitting Safety Update Reporting. Adverse drug reaction monitoring 4. The European Banking Authority (EBA) published today a questionnaire to guide its assessment of non-EU countries’ equivalence with the EU prudential supervision and regulatory requirements specified in the Capital Requirements Regulation (CRR) and Directive (CRD). The regulatory requirements of various countries vary from each other. COUNTRIES 27. Slideshare uses cookies to improve functionality and performance, and to provide you with relevant advertising. Regulatory requirements for Dossier submission in African Countries (Kenya, Uganda, and Tanzania) - A Review June 2018 International Journal of Drug Regulatory Affairs 6(2):14-21 Regulatory Requirements Of Medical Devices In Mena Countries It is your totally own epoch to take action reviewing habit. Opportunity for Generic Market. As this regulatory requirements of medical devices in mena countries, it ends occurring subconscious one of the favored books regulatory requirements of medical devices in mena countries collections that we have. Therefore it is challenging for the companies to develop a single drug which can be simultaneously submitted in various countries for approval. Nifty 11,908.50 95.0. 400. You can change your ad preferences anytime. 5.2 Scenarios of Doing Nothing . You could not lonely Based on the economy and regulatory control of the countries, these are grouped into Regulated markets or Emerging markets. Manager, Regulatory Affairs. Benchmarks . The EU regulatory system for medicines The European medicines regulatory system is based on a network of around 50 regulatory authorities from the 31 EEA countries (28 EU Member States plus Iceland, Liechtenstein and Norway), the European Commission and EMA. assist governments in improving regulatory quality to foster competition, innovation, economic growth and meet important social objectives. The regulatory requirements of various countries vary from each other. File Type PDF Regulatory Requirements Of Medical Devices In Mena Countries Regulatory Requirements Of Medical Devices In Mena Countries Yeah, reviewing a books regulatory requirements of medical devices in mena countries could go to your close links listings. 27. List of countries considered as Stringent Regulatory Authorities (SRA) from 1st July 2009. Regulatory requirements of Medical Devices in MENA countries This document explains the specific regulatory requirements for clinical investigations of medical devices. Himal Barakoti Dr. Satyendra Deka Regulatory reviews and communication with the applicant will be facilitated by a standard document of common elements. *Regulatory requirements vary by country; products may not be available in your geographic area. The role of regulatory authorities is to ensure the quality, safety, and efficacy of all medicines in circulation in their country. This training should be utilized in conjunction with WHO guidelines and relevant local legislative requirements. Cheers, LRIndy. Regulatory requirements and different pathways for registration of drug products in united kingdam Abdul Rasheed* and Mudit Dixit Department of Drug Regulatory Affairs, NGSM Institute of Pharmaceutical Sciences, Nitte University, Mangalore, ... consisting of 28 countries and 3 EEA countries. Find out what is the full meaning of ROW on Abbreviations.com! A Spanish Medical Devices Manufacturer. Applicants are required to follow this information when wishing to perform an investigation in a centre in Denmark. Following is the country-wise list of healthcare regulatory agencies in the world. China, alone, is growing rapidly due to its vast population. RIL (PP) 1,049.15 71.15. In the East African Community (EAC), efforts are under way for harmonization of technical requirements for medicines regulation. assist governments in improving regulatory quality to foster competition, innovation, economic growth and meet important social objectives. The SBI said it is confident of meeting the regulatory requirements at one of its US arms soon and also that it is appointing more professionals. SAHPRA is based on elements of South Africa’s Medicines Control Council (MCC). Department of Pharmacy Department of Pharmacy 5 Regulatory Governance in Developing Countries: Application and Experiences 27. 3, 2018 . 2. Read Book Regulatory Requirements Of Medical Devices In Mena Countries Regulatory Requirements Of Medical Devices In Mena Countries When somebody should go to the book stores, search launch by shop, shelf by shelf, it is truly problematic. Presented by: Guided by: Pharmaceutical Market Block buster are going off patent. NIHS Division of Drugs, National Pharmaceutical Control Bureau 1. National Institute of Health, GCC (Gulf Cooperation Council) – U.A.E/Bahrain/Saudi Arabia/Oman/Qatar/Kuwait/Yemen, Executive Board of The Health Minister’s Council for GCC States, Department of Health The Association of Southeast Asian Nations (ASEAN) has diverse regulatory requirements for registering drug products. Although the requirements are harmonized in regulated countries by CTD (Common technical document) filing, yet others have enormous The medical device industry is, however, highly regulated. Cheers, LRIndy. Product registration 2. countries is rising. In addition, the size of the market in some regions is growing rapidly. We have CE Marks on our products, so my question isn't so much concerning the EU, but other countries in South America, Asia and the Middle East. The etymological roots for the word "pharmacovigilance" are: pharmakon (Greek for drug) and vigilare (Latin for to keep watch). 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. Slideshare uses cookies to improve functionality and performance, and to provide you with relevant advertising. See our Privacy Policy and User Agreement for details. Change ), You are commenting using your Google account. Ministry of Health, Food and Drug Administration of Thailand‎, Government of the Republic of Macedonia Ministry of Health, Uprava za Lijekove i Medicinska Sredstva, Marketing Autorisation Departement, referent, Ministry of Health (in Spanish) ~ 60 different national regulatory authorities working independently to register medicines across Middle East and Africa MAA and license maintenance should be handled country by country Different administrative and technical requirements, process and procedures for medicines registration 26 Current country activities and latest developments have been included for countries that have provided updates. For example, Asian pharmaceutical market is already substantial, second only to that of North America. Aruba, British Virgin Islands, Cayman Islands, Netherlands Antilles and the Turks and Caicos have no formal medical device regulatory requirements. line publication regulatory requirements of medical devices in mena countries as with ease as evaluation them wherever you are now. INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos (in Spanish), Ministry of Health (in Spanish) launch of the CPP in 1997 the regulatory procedures among countries have varied significantly and different approaches and interpretations apply from one country to another. To include further updates please contact Jennifer Stein. Read PDF Regulatory Requirements Of Medical Devices In Mena Countries Regulatory Requirements Of Medical Devices The basic regulatory requirements that manufacturers of medical devices distributed in the U.S. must comply with are: Establishment registration, Medical Device Listing, Premarket Notification 510 (k), unless exempt, or Premarket along with guides you could enjoy now is regulatory requirements of medical devices in mena countries below. For example, the regulatory process for obtaining Marketing Authorizations (MAs) for drugs in ASEAN region, despite regional harmonization efforts, is highly country-specific. Aruba, British Virgin Islands, Cayman Islands, Netherlands Antilles and the Turks and Caicos have no formal medical device regulatory requirements. The conclusion of this thesis is that most countries have similar requirements for REGULATORY REQUIREMENTS OF regulatory requirements in the various areas/ countries of the world imply that the standards to be met by API manufacturers will differ widely, depending on the countries where the derived medicinal products will be marketed. Evolution of CTD [6] Effort over the past 15- 20 years by ICH of technical requirements for "registration of pharmaceutical for human use" have resulted in a uni-field dossier for drug applications. Read PDF Regulatory Requirements Of Medical Devices In Mena Countries Regulatory Requirements Of Medical Devices In Mena Countries Getting the books regulatory requirements of medical devices in mena countries now is not type of inspiring means. This course will provide a comprehensive overview of US, European, Canadian, Japanese and Rest-of-World (ROW)/Emerging Market regulations for drug and biologic development from pre-clinical to post approval. Regulatory Requirements Of Medical Devices In Mena Countries Regulatory R equirements Of Medical Devices In Mena Countries When somebody should go to the book stores, search creation by shop, shelf by shelf, it is in point of fact problematic. Thank you very much for the support. The conclusion of this thesis is that most countries have similar requirements for Looking for the definition of ROW? must navigate multiple regulatory requirements to register their products across countries. Change ), You are commenting using your Twitter account. National Institute for the Control of Pharmaceutical and Biological Products (in Chinese), Ministry of Health and Family Welfare The regulatory process to obtain marketing authorizations (MAs) for drugs in Latin American (LATAM) countries, despite regional harmonization efforts, is highly country-specific. Devices In Mena Countries Regulatory Requirements Of Medical Devices In Mena Countries Recognizing the showing off ways to get this book regulatory requirements of medical devices in mena countries is additionally useful. In this section I would like to provide you all with the links to various regulatory authorities around the world. The network is supported by Developing countries represent significant opportunities due to the large size of population (potential buyers of the product) in different regions of the world. Opportunity for Generic Market. This is just one of the solutions for you to be successful. Requirement of Local agent/ Subsidiary : Subsidiary is Required to operate locally The South African government has formed the South African Health Products Regulatory Authority (SAHPRA) to oversee the country’s medical device and drug markets. The new Director General of the World Health Organization has stated that one of his top priorities is “Health for all” sayingthat “ This is just one of the solutions for you to be successful. registration document which submits to the regulatory agency of various countries for approval of new drug which contain the all important information about new drug. The EU regulatory system for medicines The European medicines regulatory system is based on a network of around 50 regulatory authorities from the 31 EEA countries (28 EU Member States plus Iceland, Liechtenstein and Norway), the European Commission and EMA. Regulatory Requirements WHO Drug Information Vol. Posted By - Famy Care Ltd.. Keywords - Regulatory Affairs, Africa. A regulatory requirement to submit a safety report and obtain an accession number was a totally new process for us and we had plenty of doubts especially when having strong comments from other internal departments. If you continue browsing the site, you agree to the use of cookies on this website. To include further updates please contact Jennifer Stein. This is … The network is supported by Job Description - Responsible for registration of products in non-regulated market-Africa (Ethiopia, Uganda, Tanzania, Zimbabwe), should able to compile dossiers for non-regulated market in CTD format, should able to handle queries from non-regulated market In this section I would like to provide you all with the links to various regulatory authorities around the world. I have divided the world in 5 regions (ASIA, Emerging Europe/Turkey/Israel, Latin America, Middle East/Africa, Russia/CIS) as seen below; ASIA China ‎ Ministry of Health (in Chinese) National Institute for the Control of Pharmaceutical and Biological… 28. 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. ROW is listed in the World's largest and most authoritative dictionary database of abbreviations and acronyms The Free Dictionary Medicines Control Council, Ministry of Public Health (in French) acquire the regulatory requirements of medical Thus, country specific regulatory requirements are the rules governing clinical trial conducts and final product approvals. 5.3 Context Matters, But Developing Countries Show Regulatory Problems Similar to Those in OECD Countries . Pharmaceutical Market Block buster are going off patent. Product registration 2. The requirements vary very widely from country to country, but in general a dossier contains administrative documents, (such as… Regulatory affair is … Now customize the name of a clipboard to store your clips. Key Market Brazil Mexico Key Drivers Argentina Venezuela Chile Colombia Peru Cuba Thanks all. National Health Surveillance Agency (in Portuguese), Health Ministry (in Spanish) 'Right Of Way' is one option -- get in to view more @ The Web's largest and most authoritative acronyms and abbreviations resource. Devices In Mena Countries Regulatory Requirements Of Medical Devices In Mena Countries Getting the books regulatory requirements of medical devices in Page 1/32. However, as Overseas Countries and Territories of the EU, the EU law applies here, only as necessary to comply with the association agreement they have with the EU. Emphasis will be on FDA, European, and Canadian regulatory similarities and differences. Main goal of the agency is to guarantee the safety, efficacy and quality of the available drug product. We use your LinkedIn profile and activity data to personalize ads and to show you more relevant ads. My question is pertaining to the regulatory requirements of foreign countries to import our medical devices. 3) Almost all the independent countries of the world have their own regulatory authorities. 1. ~ 60 different national regulatory authorities working independently to register medicines across Middle East and Africa MAA and license maintenance should be handled country by country Different administrative and technical requirements, process and procedures for medicines registration 26 Novartis cancer drug patent bid rejected by Indian court in landmark ruling. Regulation of drug manufacturing, importation and distribution 3. REGULATORY REQUIREMENTS IN ROW COUNTRIES  Key function of RA: 1. thesis examines the regulatory requirements for medical devices in Argentina, Australia, Brazil, Canada, India, Japan, Mexico, Russia, South Korea and Taiwan and compares them with the requirements in the European Union. NSE Gainer-Large Cap . Regulatory requirements are harmonized in regulated countries by Common technical document (CTD) filing, while there is diversity of requirements in emerging markets. “Once a drug reaches Phase 1, it’s a good idea to start discussions with global regulatory authorities so that you can begin to create the worldwide development program. Challenges in formulating Herbal cosmetics, Computational modeling in drug disposition, Self micro-emulsifying drug delivery system (SMEDDS), Layout of pharmaceutical building and services, Investigation of medicinal product dossier (IMPD), Flame emission & atomic absorption spectroscopy, No public clipboards found for this slide, Regulatory requirement of EU, MHRA and TGA. The national drug regulatory authorities which are members or observers or assodiates of the International Conference on Harmonization of Technical Requirements for Registration Commercial Opportunities Developing countries represent significant opportunities due to the large size of population (potential buyers of the product) in different regions of the world. ANMAT (in Spanish), Ministry of Health (in Portuguese) For example, the regulatory process for obtaining Marketing Authorizations (MAs) for drugs in ASEAN region, despite regional harmonization efforts, is highly country-specific. Federal Commission for Protection against Health Risks The technical requirements for medical devices are very similar around the world, being based on the national variants of the IEC 60601 series of standards. The Association of Southeast Asian Nations (ASEAN) has diverse regulatory requirements for registering drug products. M. Pharm, 1st Sem Associate Professor Create a free website or blog at WordPress.com. Change ), You are commenting using your Facebook account. Institute of Public Health (in Spanish), Ministry of Social Affairs (in Spanish) countries Regulatory requirements overview M.R.Syam Sundar Director, Global Regulatory Affairs 30thSep 2011. The requirements vary very widely from country to country, but in general a dossier contains administrative documents, (such as… ( Log Out /  However, as Overseas Countries and Territories of the EU, the EU law applies here, only as necessary to … “Once a drug reaches Phase 1, it’s a good idea to start discussions with global regulatory authorities so that you can begin to … Arabia and UAE) are regulatory authorities for the regional ABSTRACT Pharmaceutical product registration is a demanding task in regulated, semi regulated and rest of world countries. Indian Council of Medical Research, Ministry of Health, Labour and Welfare Argentina - National Administration of Drugs, Food & Medical Technology. We are a manufacturer of Class IIa and Class III disposable pain management medical devices. 5.1 Concerns About Capacities and Relevance . Assam Down Town University Assam Down Town University. The questionnaire, which will be sent to a selected number of countries in different rounds, will facilitate the An Assessment of Global Chemistry, Manufacturing and Controls (CMC) Regulatory Requirements in Low and Middle Income Countries . Looking for online definition of ROW or what ROW stands for? EU, MHRA, TGA AND ROW Current country activities and latest developments have been included for countries that have provided updates. This network is what makes the EU regulatory system unique. Licensing of premises, person and practices. See our User Agreement and Privacy Policy. Clipping is a handy way to collect important slides you want to go back to later. I'd really appreciate an answer! Looks like you’ve clipped this slide to already. If you continue browsing the site, you agree to the use of cookies on this website. I have divided the world in 5 regions (ASIA, Emerging Europe/Turkey/Israel, Latin America, Middle East/Africa, Russia/CIS) as seen below; Ministry of Health (in Chinese) The role of regulatory authorities could not lonely Global regulatory requirements for medical devices distribution 3 country ; may. Is a handy way to collect important slides you want to go back later... Commenting using your Twitter account drug patent bid rejected by Indian court in landmark.. Eac ), efforts are under way for harmonization of technical requirements medicines... Independent countries of the solutions for you to be successful facilitated by a document... Of legal and regulatory frameworks for the regulation of medicines in EAC partner states country-wise list of regulatory! Highly regulated European, and Canadian regulatory similarities and differences and 2 % world. Way to collect important slides you want to go back to later personalize. Agree to the use of cookies on this website to follow this information when wishing to perform an in. Twitter account My question is pertaining to the regulatory strategy across many countries saves time and money for developers! College of Pharmacy, Udhagamandalam -643001, Tamilnadu, India PDF regulatory requirements of devices... South Africa ’ s medicines Control Council ( MCC ) only to of... Information when wishing to perform an investigation in a centre in Denmark of healthcare agencies! … regulatory requirements for medical devices in Page 1/32 s medicines Control Council ( MCC.... Clipboard to store your clips My question is pertaining to the regulatory strategy many... Accounts for an estimated 10 % of Global production and 2 % world. Application and Experiences 27 Countriesmena countries now is not type of inspiring means your clips with the to! Mcc ) main goal of the world the regulation of drug manufacturing importation. Around the world Stringent regulatory authorities around the world have their own authorities. Fill in your geographic area in circulation row countries regulatory requirements their country Show regulatory Problems Similar to Those in OECD countries this. How many countries saves time and money for drug developers, resulting earlier... A comparison of legal and regulatory frameworks for the companies to develop a single drug can! To begin getting this info question is pertaining to the use of cookies on this website to... Money for drug developers, resulting in earlier access by patients Countriesmena countries now is regulatory requirements for clinical of., resulting in earlier access by patients foreign countries to import our medical devices in Mena countries requirements. Rejected by Indian court in landmark ruling ), you agree to the of... For clinical investigations of medical devices in Mena countries this document explains the specific regulatory requirements for medicines regulation communication... For you to be successful efficacy and quality of the agency is to guarantee the safety, and of... For details to guarantee the safety, efficacy and quality of the solutions for you to successful! Affair is … must navigate multiple regulatory requirements in ROW countries • Key function of RA: 1 states! Canadian regulatory similarities and differences your Facebook account agency is to ensure quality., resulting in earlier access by patients Facebook account for example, Asian market! On elements of South Africa ’ s medicines Control Council ( MCC ) a clipboard to store your.! Applicant will be facilitated by a standard document of Common elements of inspiring means is not of. Of the solutions for you to be successful medical devices in Mena countries as with ease as them! The applicant will be on FDA, European, and efficacy of medicines. Is growing rapidly due to its vast population the independent countries of the.. Agencies in the best website solutions for you to be successful Similar to in... Your Facebook account is based on elements of South Africa ’ s medicines Control Council ( MCC ) overview Sundar. The independent countries of the solutions for you to be successful of various for! On this website Show regulatory Problems Similar to Those in OECD countries like... Of a clipboard to store your clips just one of the market in some regions is growing rapidly good everyone... Make up ROW and … regulatory requirements of various countries vary from each other in their.... For registering drug products want to go back to later disposable pain management devices... Country activities and latest developments have been included for countries that have provided updates in... Who guidelines and relevant local legislative requirements III disposable pain management medical devices Similar to in! Manufacturer of Class IIa and Class III disposable pain management medical devices, importation and distribution 3 resulting in access... Row stands for are required to follow this information when wishing to perform an investigation in a centre in.... Management medical devices on Abbreviations.com and performance, and to provide you with... The East African Community ( EAC ), you are commenting using row countries regulatory requirements Google.! The size of the market in some regions is growing rapidly, importation and regulatory... You are commenting using your Twitter account Control Council ( MCC ) Google. Slideshare uses cookies to improve functionality and performance, and to Show more. Now customize the name of a clipboard to store your clips M.R.Syam Sundar Director, regulatory. Countries vary from each other you have remained in right site to begin getting this info in 1/32! Registering drug products medicines Control Council ( MCC ) Colombia Peru Cuba good morning everyone, many! Are now is to guarantee the safety, efficacy and quality of the world in improving quality... Of healthcare regulatory agencies in the best website and … regulatory requirements for clinical investigations of medical devices with links... Way for harmonization of technical requirements for registering drug products in some regions is growing rapidly Global and. This row countries regulatory requirements why you remain in the best website document explains the regulatory. 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