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1. Are there proposals for reform or significant change to the healthcare system? The Romanian authorities announced their intention to implement certain changes in the pharmaceutical legislation, including in relation to: the new advertising norms for medical devices, which will bring significant changes in connection with the marketing and advertising activities which can be performed…
Thailand Tilleke & Gibbins October 2022
Regulatory Reforms: Thailand
Are there proposals for reform or significant change to the healthcare system? Significant changes to the healthcare system include the following: The Patent Act The Patent Act is currently under review and final revision by the Department of Intellectual Property, and is expected to be passed soon. The Act’s amendments aim to update Thai patent…
Vietnam Tilleke & Gibbins October 2022
Regulatory Reforms: Vietnam
1. Are there proposals for reform or significant change to the healthcare system? Law on Medical Examination and Treatment The draft version of an amended Law on Medical Examination and Treatment was submitted to the National Assembly in May 2022 for discussion. Once adopted, the new law will repeal the current Law on Medical Examination…
Ecuador Corral Rosales October 2018
Regulatory Reforms: Ecuador
1. Are there proposals for reform or significant change to the healthcare system? Since former president Lenin Moreno vetoed the Health Code bill (September 2020), no developments have occurred. 2. When are they likely to come into force? Uncertain.
Serbia October 2018
Regulatory Reforms: Serbia
1. Are there proposals for reform or significant change to the healthcare system? There is an overall tendency by the Government to improve the healthcare system in Serbia, especially through digitalization and investments into creating conditions for biotechnology and innovative therapies. Regarding legislative changes, a new medicines act has been in the works for some…
Denmark Gorrissen Federspiel October 2022
Regulatory Reforms: Denmark
The ins and outs of regulatory reforms in Denmark. Prepared in association with Gorrissen Federspiel, a leading law firm in Denmark, this is an extract from The Pharma Legal Handbook: Denmark, available to purchase here for GBP 119. 1. Are there proposals for reform or significant change to the healthcare system? N/A. 2. When are…
Norway October 2018
Regulatory Reforms: Norway
1. Are there proposals for reform or significant change to the healthcare system? As a party to the EEA Agreement, Norway will, as a main rule, be affected by all EU reforms in the area. The European Commission has inter alia proposed several amendments to Regulation (EU) 2017/746 on in vitro diagnostic medical devices. The…
Russia Lidings April 2024
Regulatory Reforms: Russia
Upcoming reforms in Russia’s pharma environment. Prepared in association with Lidings, a leading global law firm, this is an extract from The Pharma Legal Handbook: Russia, available to purchase here for GBP 99. 1. Are there proposals for reform or significant change to the healthcare system? Functioning of the EAEU common market for drugs and…
Panama AFRA June 2019
Regulatory Reforms: Panama
All legal aspects surrounding regulatory reforms in Panama. Prepared in association with AFRA, a leading global law firm, this is an extract from The Pharma Legal Handbook: Panama, available to purchase here for GBP 99. 1. Are there proposals for reform or significant change to the healthcare system? Currently enforced new healthcare related regulations are due…
Czech Republic PRK Partners October 2022
Regulatory Reforms: Czech Republic
A brief overview of the situation regarding regulatory reforms in Czech Republic. Prepared in association with PRK Partners, a leading law firm in Czech Republic, this is an extract from The Pharma Legal Handbook: Czech Republic, available to purchase here for GBP 119. 1. Are there proposals for reform or significant change to the healthcare…