scholarly journals General requirements for marketing authorization transfers in Thailand, Malaysia, Singapore, Indonesia and Philippines

2018 ◽  
Vol 6 (2) ◽  
pp. 59-66
Author(s):  
Jyothshna Devi Katamreddy ◽  
Prathyusha Jeeva
Keyword(s):  
Regulatory Authority ◽  
Pharmaceutical Products ◽  
Pharmaceutical Product ◽  
Review Article ◽  
Marketing Authorization ◽  
Expiry Date ◽  
Legal Entity ◽  
Process Outcomes ◽  
A Company

The review article is only for brief idea about the Marketing Authorization Transfers in few of ASEAN region. Whatever the data here I have been provided is according to my knowledge and study depends on healthy authorities/regulatory authorities sometimes requirements also may change. A Marketing Authorization Transfer is may be necessary to a company selling their product rights to another company it’s like acquisition. In Order to transfer any kind of Pharmaceutical Products in ASEAN region from one MAH to other MAH that particular product must have a Marketing Authorization Transfer issued by the competent health/Regulatory Authority. This MAT is issued to a legal entity called MAT.  It is a procedure by which the MA is transferred from the Old MAH to New MAH which is a different legal entity. The MA holder is completing responsibility for the life of the pharmaceutical product including all technical development and further alterations. The MAT process outcomes in the original MAH rights and responsibilities concerning the specific pharmaceutical product to be transferred to the New MAH on a specific date on which the transfer is stimulated. According to dossier all the parameters would be present. The expiry date is same and therefore, if applicable, the date by which it has to be renewed in order to remain legal. If any obligations are applicable (post authorization): PSUR, follow-up measures and special commitments.

scholarly journals REGULATORY PERSPECTIVES OF PHARMACEUTICAL PRODUCTS IN GHANA

2018 ◽  
Vol 2 (2) ◽  
pp. 7-15
Author(s):  
Raja Mohan Reddy G. ◽  
M. P. Venkatesh ◽  
Achin J. ◽  
Pramod Kumar T.M.
Keyword(s):  
Regulatory Authority ◽  
Generic Drugs ◽  
Pharmaceutical Products ◽  
Pharmaceutical Product ◽  
Pharmaceutical Market ◽  
Regulatory Requirements ◽  
Drug Products ◽  
Drug Registration ◽  
Good Market ◽  
Gain Access

Drug Registration is a procedure of expertise of pharmaceutical product quality, efficacy and safety by the Regulatory Authority. The emergence of various formats has enabled the manufacturers of the drug to easily gain access into various markets and thus was able to place their products into the market. The choice of Ghana as one of the destinations for the market of the Drug products ensures the manufacturer a good market value. Ghana is considered as one of the growing pharmaceutical market in east Africa. Of late, generic drugs are holding a major stake in the pharmaceutical market and are gaining more and more confidence in the usage. Majority of medicines in the Ghana are generic drugs which are considered as value for the money and affordable. With Ghana Regulatory Authority is the Food and Drugs Board, which takes decision to register the product and issues Registration Certificate. This study mainly focuses on the regulatory environment, registration process involved and the regulatory requirements that are applicable for the generic drug products in Ghana.

Review of form 483s and warning letters to pharmaceutical manufacturers issued by USFDA

2021 ◽  
pp. 174113432110235
Author(s):  
Chandan Saini ◽  
Ashish Miglani ◽  
Pankaj Musyuni ◽  
Geeta Aggarwal
Keyword(s):  
Public Health ◽  
United States ◽  
Regulatory Authority ◽  
The United States ◽  
Federal Law ◽  
Pharmaceutical Manufacturers ◽  
The World ◽  
Considerable Impact ◽  
A Company ◽  
Responsible Person

Regular inspections are carried out to ensure system conformity by the Food and Drugs Regulatory Authority (FDA) of the United States one of the most stringent regulatory authorities in the world. The inspectors send Form 483 to the management after the inspection, detailing the inappropriate conditions. Because the FDA guidelines are difficult to comply with, a company can contravene the regulations. If any significant infringements can affect the protection, quality, effectiveness, or public health of the drug is identified, the FDA issues advice to the company. Warning Letters (WL) shall be an official notification of non-compliance with federal law within a period to be issued by manufacturer, clinician, distributor, or responsible person in the company. The delivery of a letter has a considerable impact on the company's reputation and position in the market. Inadequate WL reactions could lead to a refusal, import denial, memorandum or even conviction and order. A brief study was conducted in this document of Form 483 and WL for four years (2017–2020) on an understanding the regulatory provisions.

scholarly journals A Narrative Review of Early Oral Stepdown Therapy for the Treatment of Uncomplicated Staphylococcus aureus Bacteremia: Yay or Nay?

2020 ◽  
Vol 7 (6) ◽  
Author(s):  
Michael Dagher ◽  
Vance G Fowler ◽  
Patty W Wright ◽  
Milner B Staub
Keyword(s):  
Staphylococcus Aureus ◽  
Hospital Readmission ◽  
Potential Role ◽  
Review Article ◽  
Narrative Review ◽  
Oral Antibiotics ◽  
Staphylococcus Aureus Bacteremia ◽  
Complete Treatment

Abstract Historically, intravenous (IV) antibiotics have been the cornerstone of treatment for uncomplicated Staphylococcus aureus bacteremia (SAB). However, IV antibiotics are expensive, increase the rates of hospital readmission, and can be associated with catheter-related complications. As a result, the potential role of oral antibiotics in the treatment of uncomplicated SAB has become a subject of interest. This narrative review article aims to summarize key arguments for and against the use of oral antibiotics to complete treatment of uncomplicated SAB and evaluates the available evidence for specific oral regimens. We conclude that evidence suggests that oral step-down therapy can be an alternative for select patients who meet the criteria for uncomplicated SAB and will comply with medical treatment and outpatient follow-up. Of the currently studied regimens discussed in this article, linezolid has the most support, followed by fluoroquinolone plus rifampin.

The Legal Status of a Company after Decision on Its Liquidation

2021 ◽  
Vol 10 (1-2) ◽  
pp. 138-152
Author(s):  
Viktoriia O. Khomenko ◽  
Leonid V. Efimenko ◽  
Valentyna A. Vasilyeva
Keyword(s):  
Market Economy ◽  
Legal Status ◽  
Court Decision ◽  
Entrepreneurial Activity ◽  
Legal Entity ◽  
State Register ◽  
Legal Position ◽  
Main Factors ◽  
A Company ◽  
Made In

Abstract Entrepreneurial activity is one of the main factors in the development of the market economy of the state, the internal and external markets of Ukraine and innovative industries. Therefore, the main purpose of this article is to analyse the peculiarities of the legal position of a company after a decision has been made to terminate it. It is established that the liquidation of legal entities is performed without the transfer of the rights and obligations of the liquidated enterprise to other persons, i.e. without succession. Upon liquidation of the enterprise, its rights and obligations are terminated. The current civil legislation does not provide for the limitation of the powers of the liquidation commission in cases of liquidation based on a court decision. It is argued that the liquidation commission be terminated when an entry on termination of the activity of a legal entity is made in the unified state register.

The conceptual metaphors in law—a case analysis of PRC Company Law

2018 ◽  
Vol 3 (2) ◽  
pp. 269-285 ◽  
Author(s):  
Xiaolu Wang ◽  
Yanjun Tu
Keyword(s):  
Law Enforcement ◽  
Conceptual Metaphor ◽  
Company Law ◽  
Cognitive Domain ◽  
Legal Person ◽  
Conceptual Metaphor Theory ◽  
Republic Of China ◽  
Metaphor Theory ◽  
A Company

Abstract It is said that metaphor is often than not ignored in forensic language in respect of legislation, judiciary, law enforcement and dissemination, as people think that law is a rigorous discipline and legal language is rigid, and that the use of metaphor can make the law lose its accuracy and authority. Then what is the truth? Based on the Conceptual Metaphor Theory (CMT), this study aims to investigate the conceptual metaphor in the cognitive domain of law. The authors have conducted a text analysis and a follow-up review on Company Law of the People’s Republic of China (PRC Company Law for short) and extracted five categories of conceptual metaphor centering on A COMPANY IS A LEGAL PERSON, including its identity, rights, obligations, liabilities and relationship with other companies.

scholarly journals A National Survey of Community Pharmacists on Smoking Cessation Services in Thailand

Pharmacy ◽  
2018 ◽  
Vol 6 (3) ◽  
pp. 101 ◽  
Author(s):  
Surarong Chinwong ◽  
Dujrudee Chinwong
Keyword(s):  
Smoking Cessation ◽  
Community Pharmacists ◽  
Cross Sectional Study ◽  
Postal Questionnaire ◽  
Pharmaceutical Product ◽  
Perceived Barriers ◽  
Cross Sectional ◽  
Smoking Cessation Services ◽  
First Time

Providing smoking cessation services is one role of community pharmacists in Thailand. This cross-sectional study aimed to investigate activities and barriers related to smoking cessation services provided in community pharmacies in Thailand, as well as to compare these activities and barriers between those pharmacists providing and those not providing smoking cessation services. A postal questionnaire was conducted to collect information from community pharmacists across Thailand. In all, 413 valid responses were received from 5235 questionnaires, giving a 7.9% response rate. Of the 413 respondents, 152 (37%) pharmacists provided smoking cessation services in their pharmacy. The activities of smoking cessation services varied. Time for counseling each smoker varied, a mean of 15.1 ± 10.9 min (range 1–60) per person for the first time, and 8.9 ± 6.7 min (range 1–30) for each follow-up visit. Community pharmacists, providing smoking cessation services, were more likely to have pharmacist assistants, be a member of the Thai Pharmacy Network for Tobacco Control, and have more than 1 pharmacist on duty. The most dispensed pharmaceutical product for smoking cessation was nicotine gum. Their most perceived barriers were being unable to follow-up and inadequate staff. In conclusion, only a minority of community pharmacists in Thailand are engaged in smoking cessation activities, even though some perceived barriers existed.

scholarly journals Regulatory Requirement and Step for Registration and Approval of Indian Drug Products in Overseas Market

2021 ◽  
Vol 68 (2) ◽  
Author(s):  
Rushikesh Aher ◽  
Pratik Aher ◽  
Tejas Ahire ◽  
Hitesh V. Shahare ◽  
Charulata T. Nemade
Keyword(s):  
Pharmaceutical Products ◽  
Pharmaceutical Product ◽  
Raw Material ◽  
Critical Parameters ◽  
Material Base ◽  
Technical Documentation ◽  
Regulatory Requirement ◽  
Drug Products ◽  
The World ◽  
Overseas Market

The Indian pharmaceuticals market is the third largest in terms of volume and thirteenth largest in terms of value. It has established itself as a global manufacturing and research hub. A large raw material base and the availability of a skilled workforce give the industry a definite competitive advantage. India has one of the lowest manufacturing costs in the world. The regulatory requirements of various countries of the world vary from each other. Therefore, it is challenging for Indian companies to develop a single drug that can be simultaneously submitted in all the countries for approval. The role of the regulatory authorities is to ensure the quality, safety, and efficacy of all medicines in circulation in their country. It not only includes the process of regulating and monitoring the drugs but also the process of manufacturing, distribution, and promotion of it. One of the primary challenges for regulatory authority is to ensure that the pharmaceutical products are developed as per the regulatory requirement of that country. This process involves the assessment of critical parameters during product development. This article covers the processes involved and requirements like import-export code, technical documentation, filing and reviewing process of drug master file, certificate of pharmaceutical product, common technical document (CTD), eCTD, and ACTD, for the registration and approval of Indian drug products in the overseas market.

scholarly journals Multiple Fatal Intoxications Caused by Improper Consumption of an Alcoholic Para-Pharmaceutical Product

2019 ◽  
Vol 70 (7) ◽  
pp. 2471-2476
Author(s):  
Camelia Liana Buhas ◽  
Bogdan Adrian Buhas ◽  
Lucia Georgeta Daina ◽  
Bianca Hanganu ◽  
Irina Smaranda Manoilescu ◽  
...  
Keyword(s):  
Pharmaceutical Products ◽  
Pharmaceutical Product ◽  
Chronic Ethanol ◽  
Deep Coma ◽  
Female Ratio ◽  
Examination Result ◽  
Chronic Ethanol Consumption ◽  
Male Female Ratio ◽  
Severe Intoxication ◽  
Age Range

Ingestion of cheap para-pharmaceuticals (such as disinfectants, deodorizing solutions, etc.) which are designed only for external use is an unfortunate habit encountered in the recent decades in the economically disadvantaged areas of Romania inhabited by poor, uninformed, and sanitary uneducated population. These para-pharmaceutical products are based on different concentrations of ethanol. Occasionally, the manufacturer modifies the product formula, or worse omits on the label that the ethanol was replaced with methanol, resulting in mass poisoning with a large number of casualties. The authors present a case of mass poisoning by methanol that occurred during one month and resulted in 40 cases of methanol intoxication. Only 5 out of the 40 victims survived the intoxication. All the dead victims underwent medico-legal autopsy which revealed only general features, liable to poisoning. The toxicological examination result was positive for methanol in all the cases. All the intoxicated victims were homeless; they were heavy ethanol consumers, especially of the product rubbing alcohol. The male: female ratio was 31:4 and the age range was between 25 and 70 years old, with an average of 50 years. All the victims were hospitalized in deep coma, showing obvious pathological changes specific to chronic ethanol consumption. Conclusions: some alcoholic para-pharmaceutical products manufactured for external use are ingested by chronic ethanol drinkers. When these products contain methanol, they can cause severe intoxication followed by an impressively large number of deaths.

scholarly journals PENGARUH KARAKTER KEWIRAUSAHAAN TERHADAP KEMAMPUAN USAHA DI SEKTOR HORTIKULTURA PROVINSI JAWA BARAT

2017 ◽  
Vol 3 (1) ◽  
pp. 31
Author(s):  
Yuliana Samantha ◽  
Ronnie S. Natawidjaja ◽  
Tuhpawana P. Sendjaja
Keyword(s):  
Path Analysis ◽  
Research Design ◽  
Ornamental Plants ◽  
Business Environment ◽  
West Java ◽  
Legal Entity ◽  
Environment Variables ◽  
Quantitative Descriptive ◽  
A Company

Most of Indonesia's population depend on agriculture. Agriculture is the basis for growth in the countryside. Horticultural company is a company form of business or legal entity that is engaged in the cultivation or breeding and marketing of vegetables, fruit, and ornamental plants. The research design used quantitative descriptive technique and take a case in Horticultural Company incorporated in the province of West Java. Informants research is the founder of 35 businesses horticultural businesses. Respondents were selected by simple random samplingmethod Solvin. Data were analyzed with path analysis, the business environment variables, entrepreneurial character, the ability of businesses and business improvement. Character of business founders age at age less than 54 years, including age. Average of the last education strata 1 (undergraduate). A conducive business environment and the higher the entrepreneurial character can give the effect of an increase in the ability of the business. Theseeffects are direct and indirect, of the path of the business environment 78.3%, 19.2% and entrepreneurial character. The effects of both variables 83.7% with 4% residual business capabilities and 16.3% influenced by other variables that are not covered.

scholarly journals Authorized Failure: How is Company Status?

2020 ◽  
Vol 2 (2) ◽  
Author(s):  
Fiany Alifia Lasnita ◽  
Muhamad Adji Rahardian Utama
Keyword(s):  
Limited Liability ◽  
Limited Liability Company ◽  
Legal Entity ◽  
Company Limited ◽  
Proof Of Ownership ◽  
Personal Wealth ◽  
A Company ◽  
A Share

The sense of the limited liability company is a legal entity to be able to run a business that has a capital consisting of a share, which its owners have lots of stock. Because it is composed of capital over shares that can be traded, and changes to the ownership of the company can be done without the need for a dissolution of a company. Limited liability company is a business entity and the magnitude of the capital company which are poured in a basic budget. The wealth of the company separate from the personal wealth of the owners of the company so that it can have its own treasures. Each person can have more than one stock which can be a proof of ownership of a company. The owner of the stock itself has a limited liability, i.e. as much as their shares. In the establishment of limited liability company also required permission and also some important documents that should be owned by a limited liability company to be its foundation.

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