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Johanna Harelimana
I am a junior associate, with experience advising clients on regulatory matters across several sectors, especially in life sciences, food and beverages, and environmental sectors.
I currently offer both French and international clients legal advice on product's qualification, clinical trials, market access, price and reimbursement, anti-gift regulation, advertising and promotion, e-health (including telemedicine), as well as drafting contracts (distribution, professional services, clinical trial agreements, etc). I also assist with regulatory advice on other products such as cosmetics, biocide, phytopharmaceuticals and novel food.
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Reform of the EU pharmaceutical legislation: proposals to fight against antimicrobial resistance
This article is part of a series that covers the proposed reforms to EU pharmaceutical legislation....
July 10, 2023
4 min read
An international overview of the regulatory legislation concerning telemedicine
Telemedicine has been available to healthcare providers for several years. However, it was not until quite...
April 24, 2023
1 min read
LFSS 2023: creation of a new accreditation system for teleconsultation companies
Article 53 of the Social Security Financing Act for 2023 (LFSS) created a new accreditation system for...
February 21, 2023
2 min read
Reminder of the key requirements of the anti-gift law following the €1 million+ fine of a pharmaceutical company
Breach of the “anti-gift” law
An investigation by the Directorate General for Fair...
February 2, 2023
3 min read
Publication of CNIL standards on health data processing implemented in the context of early access and compassionate use authorisations
The French data protection authority (Commission Nationale de l'Informatique et des Libertés...
January 16, 2023
2 min read
Cannabidiol (CBD): Annulment of the order prohibiting the sale of cannabis flowers and leaves
The Council of State (Conseil d’Etat) has recently annulled the government order prohibiting the sale...
January 13, 2023
2 min read
The Legal 500: Pharmaceutical Advertising Comparative Guide 2022
The latest edition of the Legal 500: Pharmaceutical Advertising Comparative Guide is now online. The...
December 12, 2022
1 min read
Publication of the English version of the new French Clinical Trial Agreement templates
The French legislator recently updated the French clinical trial agreement template also called...
October 10, 2022
2 min read
The Return of Biosimilar Substitution in France
Every year the Social Security Financing Law for 2022 (LFSS 2022) introduces several measures resulting...
March 28, 2022
3 min read
Renewal of early access and compassionate use frameworks in France
On 1 July 2021, the early access and compassionate use reform entered into force. A medical treatment...
November 10, 2021
6 min read