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https://seelegal.org/wp-content/uploads/2023/10/ccimage-gf8da33a0082083c482d282c51e3b93ae638c919c5533f4cba67fb03be0c6b587331504f87091e99e612b3cd4cd81c790.jpg 2000 3000 Ivet Goranova https://seelegal.org/wp-content/uploads/2018/01/SeeLegalLogoHeader-1.png Ivet Goranova2023-10-27 16:07:062023-10-27 16:07:41The Government of Serbia Repealed Most of the Recent Restrictions on Clinical Trials
October 2023 As SEE Legal reported, in August this year, the Government of Serbia adopted amendments to the Rulebook on clinical trials of human medicines (“Rulebook on Clinical Trials“), introducing significant changes to the clinical trials regime. The first amendment limited clinical trials to public healthcare institutions, excluding privately-owned healthcare institutions from the clinical trials system. The second amendment completely excluded the possibility of conducting phase I clinical trials (phase I, Ia, and Ib) in Serbia. The amendments caused backlash from the industry associations,…
https://seelegal.org/wp-content/uploads/2023/03/Healthcare-Program.png 454 703 Ivet Goranova https://seelegal.org/wp-content/uploads/2018/01/SeeLegalLogoHeader-1.png Ivet Goranova2023-08-24 09:10:432023-08-24 09:10:43New Restrictions to Clinical Trials in Serbia
August 2023 The Government of Serbia adopted in the beginning of August amendments to the Rulebook on clinical trials of human medicines (“Rulebook on Clinical Trials“), which entered into force on 12 August 2023. There are two significant changes that negatively affect clinical trials in Serbia. The first amendment relates to the site of a clinical trial, which is now limited to public healthcare institutions. Therefore, clinical trials can no longer be conducted in privately owned healthcare institutions. The second amendment excludes phase I clinical trials (phase I, Ia, and Ib) from…
https://seelegal.org/wp-content/uploads/2022/08/ccimage-gcb83d7c9653e009ebebd991e95be6b6f6b1fbc886c8de59506e656c6e96101769afccc1b230d56221091a988ac8c691c.jpg 3648 5472 Ivet Goranova https://seelegal.org/wp-content/uploads/2018/01/SeeLegalLogoHeader-1.png Ivet Goranova2022-08-19 10:34:512022-08-26 10:37:50Medicines Manufacturer Antibiotice Iasi Plans to Invest EUR 40 million in two New Factories
August 2022 Medicines manufacturer Antibiotice Iasi plans to invest EUR 40 million in two new factories that could produce "made in Romania" sterile products and sterile topical products. Antibiotice has invested in the development of its portfolio in the export area in the past few years, and it plans to open a new production unit dedicated to ointments and topical products, a EUR 25 million investment, in the autumn of 2022.
https://seelegal.org/wp-content/uploads/2022/08/1657716172703jpg.jpg 418 800 Ivet Goranova https://seelegal.org/wp-content/uploads/2018/01/SeeLegalLogoHeader-1.png Ivet Goranova2022-08-12 14:21:482022-08-12 14:21:48KG Law Firm Proud contributors to the Pharmaceutical Advertising 2022 Guide by ICLG
KG LawFirm has shared the latest International Comparative Legal Guide – Pharmaceutical Advertising and Regulations 2022, published by Global Legal Group. The Greek chapter authored by KG Law Firm’s Life Science & Healthcare team covers important issues in pharmaceutical advertising laws and regulations, including promotion of prescription-only medicines to healthcare professionals, prohibition of gifts, events and hospitality, donations, advertisement of non-prescription medicines, and transparency and disclosure. The chapter is available here.
https://seelegal.org/wp-content/uploads/2022/05/kg-e1653637257596.gif 540 1030 Ivet Goranova https://seelegal.org/wp-content/uploads/2018/01/SeeLegalLogoHeader-1.png Ivet Goranova2022-05-27 09:41:322022-05-27 09:41:32Joint Guidance on Virtual and Hybrid International Medical Congresses
May 2022 Authors: Irene Kyriakides, Victoria Mertikopoulou, KG Law Firm Very recently, the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), the European Federation of Pharmaceutical Industries and Associations (EFPIA), and the Pharmaceutical Research and Manufacturers of America (PhRMA) published a Joint Guidance on Virtual and Hybrid International Medical Congresses, aiming to specify the parameters and factors that Companies should consider when determining which code and/or label to use as a reference for the Company activities. The Joint Guidance clarifies,…
https://seelegal.org/wp-content/uploads/2022/02/shutterstock_1608626725-1-e1643981153426.jpg 1987 2687 Ivet Goranova https://seelegal.org/wp-content/uploads/2018/01/SeeLegalLogoHeader-1.png Ivet Goranova2022-02-04 14:26:142022-05-16 14:05:21Regulation on Veterinary Medicinal Products and Repealing Directive
February 2022 Life Sciences & Healthcare team at KYRIAKIDES GEORGOPOULOS Law Firm has circulated a Newsletter on the Regulation on veterinary medicinal products and repealing Directive 2001/82/EC that entered into practice on 28 January 2022 in Greece. The goal of the Regulation is to: Simplify the regulatory environment and reduce administrative burden for pharmaceutical companies developing veterinary medicines; Stimulate the development of innovative veterinary medicines; Strengthen EU action to fight antimicrobial resistance. The report is available here.
https://seelegal.org/wp-content/uploads/2022/01/env.jpg 755 1500 Ivet Goranova https://seelegal.org/wp-content/uploads/2018/01/SeeLegalLogoHeader-1.png Ivet Goranova2022-01-19 09:19:212022-01-19 09:19:21New Law on Environmental Impact Assessment in the Pipeline: A Step Forward in Harmonisation With the EU Acquis
January 2022 Author: Milan Dakic, BDK Advokati The Serbian Government is preparing a new Act on Environmental Impact Assessment  (“Draft EIA Act“) with the aim to further harmonise the existing environmental impact assessment (“EIA“) regulatory framework with that of the EU, which has been so far lagging behind the EU acquis, as well as to integrate the appropriate assessment procedure from the nature protection regulations into the EIA process. Key novelties EIA procedure will have to be performed before the development consent is issued The existing EIA Act requires that the…
https://seelegal.org/wp-content/uploads/2022/01/ccimage-g64f3bce9770fa9895e937c49dde308215fb15915724020090bed0595d23db2ef19de3f0afead0270ef90e9b6e7e80818.jpg 4016 6016 Ivet Goranova https://seelegal.org/wp-content/uploads/2018/01/SeeLegalLogoHeader-1.png Ivet Goranova2022-01-10 11:05:412022-01-12 14:15:45Health and Food Law Developments in 2021
January 2022 Author: Maria-Oraiozili Koutsoupia 2021 saw an unprecedented wave of regulatory changes in the health and food sectors. While the Covid-19 pandemic mandated most of the agenda, developments extended far beyond. KYRIAKIDES GEORGOPOULOS Law Firm shares an insight into the changes and developments that happened in 2021 in Greece. Find out more here.
https://seelegal.org/wp-content/uploads/2021/11/shutterstock_1686280168-e1636359913457.jpg 1999 3000 Ivet Goranova https://seelegal.org/wp-content/uploads/2018/01/SeeLegalLogoHeader-1.png Ivet Goranova2021-11-08 09:26:432021-11-08 09:26:43Processing of Personal Data Concerning Vaccinations and the EU Digital COVID-19 Certificate
November 2021 Recently, the Commission for Personal Data Protection (CPDP) published an opinion on the processing of personal data regarding the vaccination status in Bulgaria. It covers all the details regarding the EU digital COVID-19 certificates – their issuance, verification, and acceptance. In accordance with EU rules, EU certificates are only to be used to access and verify the information included therein to facilitate and allow the right of free movement within the EU during the pandemic. EU certificates can only be used for any different than the above-mentioned motives if the legal…
https://seelegal.org/wp-content/uploads/2021/08/lab.jpg 1500 2000 Ivet Goranova https://seelegal.org/wp-content/uploads/2018/01/SeeLegalLogoHeader-1.png Ivet Goranova2021-08-16 14:41:472021-10-11 12:41:01MediGroup acquired TalijaLab
August 2021 MediGroup system acquired TalijaLab, biochemical laboratories which operate in 20 locations across Serbia providing services in various fields of laboratory diagnostics: biochemistry, microbiology, and genetics. By this transaction, MediGroup has expanded its MediLab network becoming the largest network of laboratories in Serbia with laboratories in over 50 locations. BDK Advokati advised MediGroup on this transaction. The team was led by senior partner Vladimir Dasic who was accompanied by associate Sanja Dedovic and junior associate Jovana Dukovic.
https://seelegal.org/wp-content/uploads/2021/08/medical-g83b28a745_640.jpg 426 640 Ivet Goranova https://seelegal.org/wp-content/uploads/2018/01/SeeLegalLogoHeader-1.png Ivet Goranova2021-08-11 09:23:462021-08-11 09:23:46Pharmaceutical Advertising Guide in Bosnia and Herzegovina
Authors: Anisa Tomic & Bojana Bosniak-London MARIC & Co.’s partners Anisa Tomic and Bojana Bosnjak-London have produced an article on the regulation of the advertising of medicines and medical devices in Bosnia & Herzegovina. It reviews the law defining advertising of medicines/medical devices as providing information about medicines/medical devices to the general and professional public. The article also analyses whether marketing authorisation holders are allowed to encourage healthcare professionals to prescribe, issue, procure, recommend, or purchase medicines or medical devices…
https://seelegal.org/wp-content/uploads/2021/07/RMHH5J7.jpg 545 899 Ivet Goranova https://seelegal.org/wp-content/uploads/2018/01/SeeLegalLogoHeader-1.png Ivet Goranova2021-07-29 11:52:062021-07-29 11:52:06Hellenic Competition Commission sector inquiry into the provision of private healthcare and related insurance services: The HCC focuses on the interplay between Big Data and the private health care sector
Authors: Ifigeneia Argyri, Vicky Vlontzou LIFE SCIENCES & HEALTHCARE PRACTICE Hellenic Competition Commission sector inquiry into the provision of private healthcare and related insurance services: The HCC focuses on the interplay between Big Data and the private health care sector The Hellenic Competition Commission (“HCC”) initiated on 05.07.2021 a sector inquiry (“SI”) into the market of provision of private health care and related insurance services. This comes in the aftermath of the restructuring of the private health care sector over the last five years and increasing…