Regulations for the Management of Drug Safety Surveillance Article 3

The pharmaceutical dealer holding a permit for pharmaceutical preparations (hereinafter referred to as the pharmaceutical dealer) shall monitor the safety of the pharmaceutical preparations within the periods specified in the preceding article.The surveillance of pharmaceutical safety in the preceding paragraph shall cover the following:1. The preparation of a pharmacovigilance plan indicated in Article 5 and reporting indicated in Article 6.2. Collection of new drug safety data and submission of reports indicated in Articles 8 and 9.3. The preparation of the risk assessment and control plan consisting of drugs of specific types or compositions, its implementation, and submission of the reports indicated in Article 10.