Articles for the ‘Life Sciences’ Category

New year, new policy: CPVO updates its public access to documents policy

Published 12 February 2025 by Philippe de Jong ALTIUS Lawyers, Belgium

The Community Plant Variety Office (CPVO) recently revised its public access to documents policy to align with the European Union (EU)’s evolving transparency standards. Effective since 15 January 2025, the new policy seeks to ensure broad access to all documents that the CPVO holds, while protecting private parties’ commercial interests. In particular, a system of prior confidentiality requests has been put in place for applicants of Community plant variety rights (CPVR).

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European Commission proposes new PPP labelling requirements

Published 05 February 2025 by Philippe de Jong ALTIUS Lawyers, Belgium

On 6 January 2025, the European Commission published a draft proposal aimed at further harmonising labelling requirements for plant protection products (PPPs) in the European Union (EU). The proposal intends to repeal the existing labelling rules and introduce certain new requirements, including mandatory digital labelling. Since the draft proposal has not yet been formally adopted, some changes to the final version remain possible.

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Advertisement of Medicines Directed to the Public

Published 13 August 2024 by Cristina Hernández Lería Lener, Spain

The regulation of public advertising medicines in Spain aims to ensure that promotional practices are transparent, accurate, and responsible. This includes adhering to authorized technical details, presenting dosage information clearly, and avoiding misleading claims about efficacy. Advertising should be informative and comprehensible, avoiding exaggeration and ensuring that all claims are substantiated by technical data. This article explains in more detail what needs to be considered if you intend to advertise medicines in the Spanish market.

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Guideline on Medicine Priority Assessment Has Been Updated

Published 24 June 2024 by Dicle Doğan Gün + Partners, Turkey

The Turkish Medicines and Medical Devices Agency updated its Guidelines on Scientific Meetings and Educational Events for medical devices on 4 January 2024, introducing a notable change of imposing a fee for event applications, set at TRY 1,114.02, effective immediately. This update eliminates the need to upload a commitment letter for event notifications and aims to streamline processes and enhance transparency in industry activities. However, the decision to charge fees has sparked criticism for potentially reducing the number of notifications by imposing additional financial burdens on companies. Further, similar fees will apply to pharmaceutical companies, although guidelines for pharmaceutical products have not been updated yet.

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Guideline on Co-Marketing of Medicines has been Updated

Published 24 June 2024 by Dicle Doğan Gün + Partners, Turkey

The Turkish Medicines and Medical Devices Agency updated its Guidelines on Scientific Meetings and Educational Events for medical devices on 4 January 2024, introducing a notable change of imposing a fee for event applications, set at TRY 1,114.02, effective immediately. This update eliminates the need to upload a commitment letter for event notifications and aims to streamline processes and enhance transparency in industry activities. However, the decision to charge fees has sparked criticism for potentially reducing the number of notifications by imposing additional financial burdens on companies. Further, similar fees will apply to pharmaceutical companies, although guidelines for pharmaceutical products have not been updated yet.

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