17/09/2021
Regulatory reforms in Colombia – a legal guide. Prepared in association with Cavelier Abogados, a leading global law firm, this is an extract from The Pharma Legal Handbook: Colombia, available to purchase here for GBP 99. 1. Are there proposals for reform or significant change to the healthcare system? Yes, Currently is in course a modification for the Decree 677 which is the principal regulatory framework for drugs, cosmetics, pharmaceutical preparations based on natural resources, cleaning and hygiene products and…
08/09/2021
Regulatory reforms to watch out for in Portuguese pharma. Prepared in association with Cuatrecasas, a leading law firm in Portugal, this is an extract from The Pharma Legal Handbook: Portugal, available to purchase here for GBP 99. 1. Are there proposals for reform or significant change to the healthcare system? As far as publicly made available by the Portuguese Government and Parliament, there is no proposals for reform or significant changes to the healthcare system. In any case, with respect…
30/08/2021
The key facts about regulatory reforms in Chinese pharma. Prepared in association with Fangda Partners, one of China’s most prestigious and well-regarded law firms. This is an extract from The Pharma Legal Handbook: China, which can be purchased here for GBP 99. 1. Are there proposals for reform or significant change to the healthcare system? Reform of Medical Insurance Payments To improve the cost-effectiveness of the current healthcare system, pilot policies of Diagnosis-Related Groups (“DRG”) payments have been implemented…
23/07/2021
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 99. 1. Are there proposals for reform or significant change to the healthcare system? Digitalization With respect to Czech legislation, the main topic of proposed regulatory changes is the ongoing process of digitalization. The Ministry of Health is…
10/07/2021
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 the EAEU common market for medical devices. The authorization of distance selling of OTC drugs subject to the following requirements: The following types of drugs…
27/04/2021
The key facts about regulatory reforms in the UAE. Prepared in association with STA, a leading law firm in the UAE, this is an extract from The Pharma Legal Handbook: UAE, available to purchase here for GBP 75. 1. Are there proposals for reform or significant change to the healthcare system? On 19 December 2019, the UAE government adopted a new federal law which was to overhaul Law No. 4 of 1983 on the Pharmacy Professional and Pharmaceutical Establishments…
20/04/2021
All legal aspects surrounding the regulatory reforms in the Polish pharma market. Prepared in association with DLA Piper, a leading law firm in Poland, this is an extract from The Pharma Legal Handbook: Poland, available to purchase here for GBP 75. 1. Are there proposals for reform or significant change to the healthcare system? Proposed legislation on medical devices At the beginning of 2020, a new act on medical devices was published on the website of the Polish Government Legislation…
30/05/2020
The legal framework for regulatory reforms in Vietnamese Pharma. Prepared in association with Tilleke & Gibbins, a leading law firm in Vietnam, this is an extract from The Pharma Legal Handbook: Vietnam, available to purchase here for GBP 75. 1. Are there proposals for reform or significant change to the healthcare system? The MOH published a draft version of an amended Law on Medical Examination and Treatment dated 12 October 2019 to collect public opinions. Once adopted, the new…
Keen to learn more about regulatory reforms in Venezuelan Pharma? Read on! Prepared in association with Hoet Pelaez Castillo & Duque (HPCD), a leading law firm in Venezuela, this is an extract from The Pharma Legal Handbook:Venezuela, available to purchase here for USD 99. 1. Are there proposals for reform or significant change to the healthcare system? We are not aware of any reform or proposed change within the health system. 2. When are they likely to come…
29/05/2020
Key legal info on regulatory reforms in Swiss Pharma. Prepared in association with Wenger Plattner, a leading law firm in Switzerland, this is an extract from The Pharma Legal Handbook: Switzerland, available to purchase here for USD 99. 1. Are there proposals for reform or significant change to the healthcare system? The revised Therapeutic Products Act (TPA) entered into force on 1 January 2019. Current therapeutic products legislation projects are listed on the website of the Federal Office of…
28/05/2020
Keen to learn more about regulatory reforms in Norwegian Pharma? Read on! Prepared in association with DLA Piper, a leading law firm in Norway, this is an extract from The Pharma Legal Handbook: Norway, available to purchase here for USD 99. 1. Are there proposals for reform or significant change to the healthcare system? The most relevant changes to the Norwegian healthcare system expected to enter into force in the near future are the following: – the new EU…
04/02/2020
Keen to learn more about regulatory reform in Zimbabwe? Read on! Prepared in association with Honey & Blanckenberg, a leading law firm in Zimbabwe, this is an extract from The Pharma Legal Handbook: Zimbabwe, available to purchase here for USD 99. 1. Are there proposals for reform or significant change to the healthcare system? Currently, there is no proposal for reform in the form of proposed or draft legislation. The last major proposal for reform was the Public Health…
03/02/2020
Key legal info on regulatory reform in Ireland. Prepared in association with Mason Hayes & Curran, a leading law firm in Ireland, this is an extract from The Pharma Legal Handbook: Ireland, available to purchase here for USD 99. 1. Are there proposals for reform or significant change to the healthcare system? In Ireland, there is currently no mechanism for class actions; however, the Multi-Party Action Bill 2017 is making its way through the legislative system. If this piece…
23/01/2020
The key facts about regulatory reforms in Italy. Prepared in association with DLA Piper, a leading law firm in Italy, this is an extract from The Pharma Legal Handbook: Italy, available to purchase here for USD 99. 1. Are there proposals for reform or significant change to the healthcare system? The most relevant reforms to the Italian healthcare system expected to enter into force in the near future are the following: the new EU regulations on medical devices, namely Regulation (EU) 745/2017…
22/01/2020
The key facts about regulatory reforms in Belgium. Prepared in association with ALTIUS, a leading law firm in Belgium, this is an extract from The Pharma Legal Handbook: Belgium, available to purchase here for USD 99. 1. Are there proposals for reform or significant change to the healthcare system? As of recently, attempts have been made to remedy the unavailability of medicines on the Belgian market. The Act of 7 April 2019 on the unavailability of medicines introduced two measures in this…
19/01/2020
Regulatory reforms in Algerian Pharma – a comprehensive legal overview. Prepared in association with SAARPE Association, a leading law firm in Algeria, this is an extract from The Pharma Legal Handbook: Algeria, available to purchase here for USD 99. 1. Are there proposals for reform or significant change to the healthcare system? Yes, there is an important reform that is ongoing and which concerns the authority in charge of regulating drugs, biologicals and medical devices for human use at…
11/11/2019
Want to know more about regulatory reforms in United Kingdom? Read on! Prepared in association with Clyde & Co, a leading law firm in United Kingdom, this is an extract from The Pharma Legal Handbook: United Kingdom, available to purchase here for USD 99. 1. Are there proposals for reform or significant change to the healthcare system? The UK is currently due to leave the EU on 31 October 2019. There is much uncertainty as to the effect that this will have…
09/11/2019
Keen to learn more about regulatory reforms in Thailand? Read on! Prepared in association with Tilleke & Gibbins, a leading law firm in Thailand, this is an extract from The Pharma Legal Handbook: Thailand, available to purchase here for GBP 75. 1. Are there proposals for reform or significant change to the healthcare system? 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…
07/11/2019
Regulatory reforms in Nigerian Pharma – a comprehensive legal overview. Prepared in association with Olaniwun Ajayi LP, a leading law firm in Nigeria, this is an extract from The Pharma Legal Handbook: Nigeria, available to purchase here for USD 99. 1. Are there proposals for reform or significant change to the healthcare system? There are currently various bills before the National Assembly (legislative arm in Nigeria) for the repeal and re-enactment of the extant National Health Insurance Scheme Act, which provides for…
08/10/2019
An insight into regulatory reforms in Malaysian Pharma. Prepared in association with Skrine, a leading law firm in Malaysia, this is an extract from The Pharma Legal Handbook: Malaysia, available to purchase here for USD 99. 1. Are there proposals for reform or significant change to the healthcare system? The followings are some of the regulatory proposals and reforms in the pharmaceutical industry in Malaysia: online registration system. In 2017, the NPRA, MOH officially launched the upgraded online registration system, QUEST3+…
23/08/2019
The low-down on the situation regarding regulatory reforms in Bulgaria. Prepared in association with Kinstellar and PharmDedict, this is an extract from The Pharma Legal Handbook: Bulgaria, available to purchase here for GBP 75. 1. Are there proposals for reform or significant change to the healthcare system? The topic of changing the existing healthcare system has been thoroughly debated in Bulgaria. In the final quarter of 2018, the Bulgarian minister of healthcare proposed two alternative models (“Model A” and…
09/08/2019
The key facts about regulatory reforms in Japanese Pharma. Prepared in association with Nishimura & Asahi, a leading law firm in Japan, this is an extract from The Pharma Legal Handbook: Japan, available to purchase here for USD 99. 1. Are there proposals for reform or significant change to the healthcare system? There is no significant reform or change to the healthcare system in Japan. However, there are small changes every year. For example, changes due to technology, telemedicine, apps as…
18/07/2019
Want to know more about regulatory reforms in Spain? Read on! Prepared in association with Faus & Moliner Abogados, a leading law firm in Spain, this is an extract from The Pharma Legal Handbook: Spain, available to purchase here for USD 99. 1. Are there proposals for reform or significant change to the healthcare system? At present, the main proposals for regulatory reform are referred to the Spanish regulations on: price and reimbursement of medicinal products and medical devices, advertising of medicinal…
17/07/2019
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 75. 1. Are there proposals for reform or significant change to the healthcare system? Clinical Trial Regulation The aim of the Clinical Trial Regulation is to ensure greater harmonisation of the rules on clinical trials throughout the EU. To this end, it will introduce,…
09/07/2019
An insight into regulatory reforms in Ukrainian pharma. Prepared in association with Sayenko Kharenko, a leading law firm in Ukraine, this is an extract from The Pharma Legal Handbook: Ukraine, available to purchase here for USD 99. 1. Are there proposals for reform or significant change to the healthcare system? N/A 2. When are they likely to come into force? N/A
08/07/2019
Regulatory reforms in Peru – an overview. Prepared in association with Osterling Abogados, a leading global law firm, this is an extract from The Pharma Legal Handbook: Peru, available to purchase here for GBP 75. 1. Are there proposals for reform or significant change to the healthcare system? There are no proposals that imply a significant change to the healthcare system. 2. When are they likely to come into force? N/A
Regulatory reforms in Greece – a comprehensive legal overview. Prepared in association with Calavros Law Firm, a leading global law firm, this is an extract from The Pharma Legal Handbook: Greece, available to purchase here for USD 99. 1. Are there proposals for reform or significant change to the healthcare system? A. The recently enacted Law 4578/2018 on the “Reduction of social security contributions and other provisions” establishes under its paragraph 12 the new percentages of imposed reduction (namely “rebate”) on the…
The key facts about regulatory reforms in Ecuadorian Pharma. Prepared in association with Corral Rosales, a leading global law firm, this is an extract from The Pharma Legal Handbook: Ecuador, available to purchase here for GBP 75. 1. Are there proposals for reform or significant change to the healthcare system? Currently there are no proposals to change the Law. 2. When are they likely to come into force? It is unlikely that the new law will be approved this year…
04/07/2019
An insight into regulatory reforms in Bolivian Pharma. Prepared in association with Indacochea & Asociados, a leading Bolivian law firm, this is an extract from The Pharma Legal Handbook: Bolivia, available to purchase here for USD 99. 1. Are there proposals for reform or significant change to the healthcare system? For several years now they have been talking about a new law that will be issued but we don’t expect it to pass any time soon. 2. When are…
02/07/2019
The ins and outs of regulatory reforms in Nicaragua. Prepared in association with Bendaña & Bendaña, a leading Nicaraguan law firm, this is an extract from The Pharma Legal Handbook: Nicaragua, available to purchase here for GBP 75. 1. Are there proposals for reform or significant change to the healthcare system? No 2. When are they likely to come into force? N/A Click the following links to read more legal articles from Nicaragua: Regulatory Pricing and Reimbursement Overview…
The legal framework for regulatory reform in Slovakian Pharma. Prepared in association with PRK Partners, a leading global law firm, this is an extract from The Pharma Legal Handbook: Slovakia, available to purchase here for GBP 75. 1. Are there proposals for reform or significant change to the healthcare system? E-Health With effect as of 1 January 2018, mandatory e-Health system has been introduced in the Slovak Republic. This reform included the introduction of an electronic health book of a patient,…
30/06/2019
The ins and outs of regulatory reforms in Romania. Prepared in association with Mușat & Asociații, a leading global law firm, this is an extract from The Pharma Legal Handbook: Romania, available to purchase here for GBP 75. 1. Are there proposals for reform or significant change to the healthcare system? The Romanian authorities announced their intention to implement certain reform or significant change to changes in the pharmaceutical legislation, including in relation to: healthcare system? improving the legal framework for…
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 75. 1. Are there proposals for reform or significant change to the healthcare system? Current enforce new healthcare related regulations are due to Covid-19 preventions, extraordinary and temporary measures enacted until the state of emergency is declared by the Panamanian Government. 2. When are they likely…
29/06/2019
The key facts about regulatory reform in Luxembourg. Prepared in association with Wildgen, a leading global law firm, this is an extract from The Pharma Legal Handbook: Luxembourg, available to purchase here for USD 99. 1. Are there proposals for reform or significant change to the healthcare system? Yes, the ongoing draft law n°7383 which has been filed to the Chamber of Deputies on 25 October 2018 by the Minister of Health contains several proposals for reform that includes, without being exhaustive:…
The ins and outs of regulatory reform in Indonesia. Prepared in association with ABNR, a leading global law firm, this is an extract from The Pharma Legal Handbook: Indonesia, available to purchase here for USD 99. 1. Are there proposals for reform or significant change to the healthcare systems? There are number of proposals of laws and regulations that may affect the pharmaceutical and medical devices industry in Indonesia, including: Bill on Drugs and Food Supervision Law The Bill has been submitted…
28/06/2019
All legal aspects surrounding regulatory reform in Germany. Prepared in association with Heuking Kühn Lüer Wojtek, a leading global law firm, this is an extract from The Pharma Legal Handbook: Germany, available to purchase here for USD 99. 1. Are there proposals for reform or significant change to the healthcare system? Two reforms came into law on January 1, 2019. The first one concerns the reduction of health insurance premiums for employees. It is named the “GKV-Versichertenentlastungsgesetz” (GKV-VEG) which…
An intro to the legal situation for regulatory reforms in Egypt. Prepared in association with Youssry Saleh Law Firm, a leading global law firm, this is an extract from The Pharma Legal Handbook: Egypt, available to purchase here for GBP 75. 1. Are there proposals for reform or significant change to the healthcare system? No, but the Comprehensive Health Insurance Scheme Law No. 2 of the year 2018 was issued on 11th of January 2018 and its Executive Regulations…
27/06/2019
An insight into upcoming regulatory reforms affecting Croatia pharma. Prepared in association with Danijel Pribanić, a leading global law firm, this is an extract from The Pharma Legal Handbook: Croatia, available to purchase here for GBP 99. 1. Are there proposals for reform or significant change to the healthcare system? Bill of Ordinance on benchmarks for the classification of medicinal products on basic and additional list of medicinal products of the Croatian Health Insurance Fund and on benchmarks on…
26/06/2019
An insight into upcoming regulatory reforms affecting Chile pharma. Prepared in association with Carey, a leading global law firm, this is an extract from The Pharma Legal Handbook: Chile, available to purchase here for GBP 99. 1. Are there proposals for reform or significant change to the healthcare system? A bill that will modify the Sanitary Code is currently under discussion. Main topics covered by this bill of law are: (i) prescription by INN; (ii) labeling; (iii) interchangeability of…
01/03/2019
Upcoming regulatory reforms in Singaporean pharma. Prepared in association with Drew & Napier LLC, this is an extract from The Pharma Legal Handbook: Singapore, available to purchase here for USD 99. 1. Are there proposals for reform or significant change to the healthcare system? PROPOSED HEALTHCARE SERVICES BILL Currently, hospitals and private medical clinics are regulated under the Private Hospitals and Medical Clinics Act (PHMCA), which was first enacted in 1980. Since then, there have been significant changes to the healthcare…
28/01/2019
An insight into upcoming regulatory reforms affecting Canadian pharma. Prepared in association with Fasken, a leading global law firm, this is an extract from The Pharma Legal Handbook: Canada, available to purchase here for USD 99. 1. Are there proposals for reform or significant change to the healthcare system? There are three significant changes which may affect or impact healthcare in Canada. NATIONAL PHARMACARE Currently, Canada is the only member country of the Organization for Economic Co-operation and Development with universal public health…
23/01/2019
A brief insight into upcoming regulatory reforms in Brazilian pharma. Prepared in association with Trench, Rossi e Watanabe one of Brazil’s most prestigious law firms, this is an extract from The Pharma Legal Handbook: Brazil, which can be purchased for GBP 75, here. 1. Are there proposals for reform or significant change to the healthcare system? There are plenty of Law projects under discussion. Before ANVISA there are two relevant rules under public consultation, one to regulate Good Practices for Pharmacovigilance and other…
08/11/2018
Regulatory reform in Lithuania – a comprehensive legal overview. Prepared in association with TGS Baltic, a leading law firm in Lithuania, this is an extract from The Pharma Legal Handbook: Baltics, available to purchase here for USD 99. 1. Are there proposals for reform or significant change to the healthcare system? Yes, there are proposals for reforms in the healthcare system. At this moment, the following initiatives are being considered: allowing the sale of prescription medicinal products online; allowing the sale…
The latest regulatory reforms in Latvian pharma. Prepared in association with TGS Baltic, a leading law firm in Latvia, this is an extract from The Pharma Legal Handbook: Baltics, available to purchase here for USD 99. 1. Are there proposals for reform or significant change to the healthcare system? Procedure on Medicine Advertising The rules provide that marketing authorization holder will have to submit data about organized and sponsored events – concerning remuneration of lecturers and consultants, technical equipment, catering, etc.…
07/11/2018
Key legal info on regulatory reforms in Estonia. Prepared in association with TGS Baltic, a leading law firm in Estonia, this is an extract from The Pharma Legal Handbook: Baltics, available to purchase here for USD 99. 1. Are there proposals for reform or significant change to the healthcare system? According to the current plan and corresponding legislation, reform concerning owning pharmacies will be finalized in two years. The aim of the reform is to separate wholesale and retail sale…
06/11/2018
Key legal info on regulatory reforms in Uruguay. Prepared in association with FERRERE, a leading law firm in Uruguay, this is an extract from The Pharma Legal Handbook: Uruguay, available to purchase here for USD 99. 1. Are there proposals for reform or significant change to the healthcare system? Currently, a project to reform drugs regulations is being reviewed by the MSP (e.g. expedited proceedings, validity term of authorizations, etc.). 2. When are they likely to come into force? Between…
The legal framework for regulatory reforms in Turkey. Prepared in association with Moroğlu Arseven, a leading Turkish law firm, this is an extract from The Pharma Legal Handbook: Turkey, available to purchase here for GBP 75. 1. Are there proposals for reform or significant change to the healthcare system? No proposals for reform exist or are expected in the short term. However, minor amendments of existing laws and regulations may occur. The Draft Regulation on the Registration, Surveillance and Tracking…
12/10/2018
Regulatory reforms in South African Pharma – a comprehensive legal overview. Prepared in association with Fasken, a leading global law firm, this is an extract from The Pharma Legal Handbook: South Africa, available to purchase here for USD 99. 1. Are there proposals for reform or significant change to the healthcare system? NATIONAL HEALTH INSURANCE BILL AND MEDICAL SCHEMES AMENDMENT BILL On 21 June 2018 the Minister of Health Published the Medical Schemes Amendment Bill and the National Health Insurance…
11/10/2018
Upcoming regulatory reforms affecting Indian pharma. Prepared in association with Nishith Desai & Associates, a leading law firm in India, this is an extract from The Pharma Legal Handbook: India, available to purchase here for GBP 75. 1. Are there proposals for reform or significant change to the healthcare system? E-pharmacy regulations The Government has recently released draft regulations that propose to create a streamlined system of licensing e-pharmacies and governing the sale of drugs online. The rules grant legal recognition…
09/08/2018
An insight into upcoming regulatory reforms affecting Argentinian pharma. Prepared in association with Marval, O’Farrell & Mairal, a leading global law firm, this is an extract from The Pharma Legal Handbook: Argentina, available to purchase here for GBP 99. 1. Are there proposals for reform or significant change to the healthcare system? There are no proposals for reform or significant change of the healthcare system in the short term. Nonetheless, due to the COVID-19 pandemic, several new regulations and laws have…
25/10/2016
Upcoming regulatory reforms in Mexican pharma. Then read on! Prepared in association with Olivares, a leading global law firm, this is an extract from The Pharma Legal Handbook: Mexico, available to purchase here for GBP 99. 1. Are there proposals for reform or significant change to the healthcare system? INITIATIVE BIOTECHNOLOGY MEDICINES (amends article 222 Bis of the General Health Law) Public health institutions should establish an effective differentiation mechanism to ensure adequate pharmacovigilance and continuity of medical treatment, thus preventing…
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