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
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- EP ID EP329330
- DOI 10.22270/ijdra.v6i2.244
- Views 129
- Downloads 0
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