{"id":10329,"date":"2025-01-23T10:36:04","date_gmt":"2025-01-23T10:36:04","guid":{"rendered":"https:\/\/www.dhenne-avocats.fr\/?post_type=lexique&p=10329"},"modified":"2025-01-23T10:36:04","modified_gmt":"2025-01-23T10:36:04","slug":"extension-pediatrique-dun-ccp","status":"publish","type":"lexique","link":"https:\/\/www.dhenne-avocats.fr\/en\/intellectual-property-glossary\/extension-pediatrique-dun-ccp\/","title":{"rendered":"Pediatric extension (of an SPC)"},"content":{"rendered":"

The pediatric extension<\/strong> is a legal mechanism that allows the protection conferred by a Supplementary Protection Certificate (SPC)<\/strong><\/a>, which itself extends a pharmaceutical patent, to be extended by six months<\/strong>. Its purpose is to encourage laboratories to conduct specific clinical studies<\/strong> on the pediatric population (infants, children, adolescents), in order to guarantee the safety<\/strong> and efficacy<\/strong> of medicines for these vulnerable groups.<\/p>\n

Conditions for obtaining a Paediatric Extension<\/h3>\n
    \n
  1. Paediatric Investigation Plan (PIP)<\/strong>:
    \nThe laboratory must have carried out the paediatric studies in accordance with the PIP approved by the     European Medicines Agency (EMA)<\/strong><\/a>.<\/li>\n
  2. Marketing Authorization (MA)<\/strong>:
    \nThe medicinal product must have a     MA<\/strong><\/a> that includes paediatric data in its Summary of Product Characteristics (SPC)<\/strong>.<\/li>\n
  3. Valid Supplementary Protection Certificate (SPC)<\/strong>:
    \nThe pediatric extension only applies to a medicine that already has an SPC.<\/li>\n<\/ol>\n

    Benefits of the Pediatric Extension<\/h3>\n
      \n
    • Extension of profitability<\/strong>: It offers an additional 6 months of exclusive commercial protection, thus delaying the arrival of generics.<\/li>\n
    • R&D incentive<\/strong>: Encourages investment in pediatric studies, which are often costly and complex.<\/li>\n
    • Public health impact<\/strong>: Ensures that medicines are adapted to the specific needs of children.<\/li>\n<\/ul>\n

      Limitations<\/h3>\n
        \n
      • The 6-month period is fixed and non-extendable<\/li>\n
      • The laboratory must demonstrate that all regulatory conditions have been strictly adhered to.<\/li>\n<\/ul>\n

         <\/p>","protected":false},"parent":0,"template":"","class_list":["post-10329","lexique","type-lexique","status-publish","hentry"],"acf":[],"yoast_head":"\nExtension p\u00e9diatrique (d'un CCP) - Dhenne Avocats<\/title>\n<meta name=\"description\" content=\"Extension p\u00e9diatrique (d'un CCP) : D\u00e9finition et explications juridiques du terme sur le lexique Dhenne Avocats.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.dhenne-avocats.fr\/en\/intellectual-property-glossary\/extension-pediatrique-dun-ccp\/\" \/>\n<meta property=\"og:locale\" content=\"en_GB\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Extension p\u00e9diatrique (d'un CCP) - Dhenne Avocats\" \/>\n<meta property=\"og:description\" content=\"Extension p\u00e9diatrique (d'un CCP) : D\u00e9finition et explications juridiques du terme sur le lexique Dhenne Avocats.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.dhenne-avocats.fr\/en\/intellectual-property-glossary\/extension-pediatrique-dun-ccp\/\" \/>\n<meta property=\"og:site_name\" content=\"Dhenne Avocats\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Estimated reading time\" \/>\n\t<meta name=\"twitter:data1\" content=\"2 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\/\/www.dhenne-avocats.fr\/lexique-propriete-intellectuelle\/extension-pediatrique-dun-ccp\/\",\"url\":\"https:\/\/www.dhenne-avocats.fr\/lexique-propriete-intellectuelle\/extension-pediatrique-dun-ccp\/\",\"name\":\"Extension p\u00e9diatrique (d'un CCP) - 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