№ lp_1_31969
Provides detailed procedural instructions for submitting applications for compassionate use and medical need programs, including dossier content, labeling, patient inclusion, and publication requirements for authorized and non-authorized medicinal products.
Year: 2014
Country: Belgium
Legislation: Royal Decree of 14/12/2006 as amended by Royal Decree of 25/04/2014
Type of document: Regulatory guidance
Target audience: Pharmaceutical companies, healthcare professionals
Subject: Compassionate use programs and medical need programs
Procedures included: Submission process, dossier requirements, publication information, labeling, pharmacovigilance
Reference: Regulation 726/2004, Article 6
Price: 8 / 10 USD
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