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HomeStudy on the options for a unified supplementary protection certificates (SPCs) system in Europe
Study on the options for a unified supplementary protection certificates (SPCs) system in Europe
Métadonnées de la publication
The study deals with the options for creating a unified procedure for examining or granting SPCs on the basis of a regional application, and to this effect considers primarily two options: a PCT model, where a single authority examines a regional application for an SPC by drafting a single examination report, but the NPOs decide whether to grant or refuse the certificate taking into account the report on hand; and an EPC model, where the decision-making power is transferred from the NPOs to the central body and the single authority decides whether a certificate shall be granted or refused. The analysis considers the institutional options for implementing the two models, their respective advantages and drawbacks, their implications for judicial review as well as possible safeguards to mitigate the concerns of some NPOs that the unified procedure could result in lowering the bar for granting certificates currently ensured by their practice.
- Publié:
- Service(s) auteur(s): Direction générale du marché intérieur, de l’industrie, de l’entrepreneuriat et des PME (Commission européenne) , Max Planck Institute for Innovation and Competition
- Auteurs personnel(s): Romandini, Roberto
- Thèmes: Rapprochement des législations , Industrie pharmaceutique et cosmétique
- Sujet: autorisation de vente , brevet européen , libre circulation des marchandises , législation , législation pharmaceutique , médicament , norme de commercialisation , produit phytosanitaire , santé publique
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| ISSN | ISBN 978-92-76-28506-9 | DOI 10.2873/63550 | Numéro de catalogue ET-02-21-008-EN-N |
- Released on EU Publications:
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