Further to our previous client alert on the Proposed Amendments to the Drug Act: Enhancing Efficiency of Drug Approval Process and Protection for Consumers, the amendment to the Drug Act (No. 6), B.E. 2562 (AD 2019) ("Drug Act") was published in the Government Gazette on 16 April 2019 and will come into force 180 days after publication, on 13 October 2019.
As per the proposed amendments under the bill, the Drug Act still contains the key amendments that allow experts who meet the required qualifications to enroll with the Food and Drug Administration Thailand ("FDA") in order to evaluate academic documents, conduct product analyses and audit business premises on behalf of the FDA. Subordinate regulations on the criteria, method and conditions for enrollment of experts are to be subsequently announced under the Drug Act.
The Drug Act also maintains the proposed requirement for an applicant for drug registration to provide documents containing information about the relevant patent or petty patent and the validation period of a drug registration license. Drug registration licenses issued before the Drug Act comes into force will remain valid for five to nine years (depending on the year that such licenses were issued), in accordance with the draft provision under the bill. However, the validation period of drug registration licenses to be granted after the enforcement of the Drug Act has now been extended to seven years instead of five years from the date of issue as specified in the bill.
For further information, please do not hesitate to contact us.