General requirements for marketing authorization transfers in Thailand, Malaysia, Singapore, Indonesia and Philippines
Journal Title: International Journal of Drug Regulatory Affairs - Year 2018, Vol 6, Issue 2
Abstract
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
Authors and Affiliations
Prathyusha Jeeva, Jyothshna Devi Katamreddy
Keywords
Related Articles
- EP ID EP329330
- DOI 10.22270/ijdra.v6i2.244
- Views 135
- Downloads 0
Preliminary requirement for ANDA Filing
USFDA is very critical regulated agency for submission. This review reveals how to submit an Abbreviated New Drug Application (ANDA) as per FDA under section 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act)...
A COMPREHENSION STUDY ON REGULATION OF HERBAL DRUGS IN USA, EUROPEAN UNION AND INDIA
The present study reviews the regulations of herbal drugs in the EU, US and India and throws light upon issues related to their clinical trials. Herbal drugs have been used for a long time in different systems of health...
REGULATORY REQUIREMENTS & MARKETING AUTHORIZATION OF GENERIC DRUGS IN SINGAPORE & THAILAND
The availability of generic medication is an important issue in the ASEAN region. The regulatory requirements of various countries vary from each other. Therefore, it is challenge for the companies to get drug approved f...
PREPARATION & COMPILATION OF ACTD DOSSIER (PART II QUALITY)
ACTD is a critical document for drug substance and produces registration in ASEAN region. The document is essentially divided into 4 parts. Each part provides information under specific head. Out of all the parts, the pa...
MEDICAL DEVICES AND THEIR APPROVAL PROCEDURE IN INDIA
Therapeutic treatment based on medical devices is providing technologically advanced solutions for the management of several diseases. Thereby continues to grow in market at tremendous rate. However, these treatments als...