On October 21, 2021, the MDCG published a new question and answer document on the procedures governing the relabeling and repackaging of medical devices under Article 16 of the MDR and IVMDR.
On November 25, 2021, the AIFA published two new simplified negotiation procedures for (i) the negotiation of generic or biosimilar drugs and reimbursement applications for the extension of indications already reimbursed for the originator, and (ii) the reimbursement of new packages for changes in the primary packaging.
In October 2021, the Medical Device Coordination Group (MDCG) published the third revision of the MDCG 2019-6 Questions and answers: Requirements relating to notified bodies, which provides clarification on the operating procedures of notified bodies responsible for performing conformity assessment activities under Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices.
In a recent interview Mr. Anutin Charnvirakul, the Minister of Public Health, lauded the many community enterprises all over Thailand which have been growing cannabis for hospitals to extract for medical purposes and the hundreds of medical cannabis clinics all over the country which have proven to be very popular with the Thai people. The Minister was pleased with how Thai people have embraced cannabis and has again stressed his mission to make cannabis both a cash crop, as well as a medicine, for the nation. He also mentioned intended efforts to continue with liberalizing the laws and regulations on cannabis even further to increase access to cannabis.
In the current narcotics and psychotropic substances regulatory regime, there are numerous laws governing narcotics and psychotropic substances which are enforced by different regulatory bodies. The Thai government aims to modernize certain current provisions and to incorporate these laws into the Narcotics Code for ease of reference and consistency in law enforcement.
The Ministry of Public Health has issued notifications to amend the list of formula of Thai traditional medicine containing cannabis under the Herbal Product Act which is allowed for use to treat a disease or for research, and to amend the information, warnings or precautions required to be displayed on the package inserts of Thai traditional medicine containing cannabis.
On November 17, 2021, the Ministry of Health published a circular letter to clarify certain aspects related to the application of Regulation 2017/745 on medical devices, including those concerning the registration in the national database of medical devices, custom-made devices, and medical device advertising.
In the aftermath of COVID-19 and the resulting low-yielding environment, sovereign actors are looking more than ever to real estate, infrastructure, private equity, private debt and other alternative assets for strategic investment opportunities.
On 10 November 2021, Decree 10,854 was published, addressing several infra-constitutional labor provision on various topics, such as food vouchers, registration before the Workers Feed Program, and transportation vouchers, as well as bringing new labor regulations, such as the Permanent Program for the Consolidation, Simplification and De bureaucratization of Infra-Legal Labor Regulations, and the Electronic Labor Inspection Book.
On 21 October 2021, HM Treasury published its much-anticipated consultation on the regulation of buy-now-pay-later products. The consultation arrives nearly seven months after the Treasury confirmed that it would formally consult on bringing BNPL products into the regulatory perimeter “as a matter of priority”.