Drugs announced or approved by the central competent health authority as required by Paragraph 1 of Article 10. New drugs as indicated in Article 7 of the Act.Ģ. 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.Ĭhinese medicines that meet one of the following conditions, are applicable under these Regulations:ġ. Collection of new drug safety data and submission of reports indicated in Articles 8 and 9.ģ.
The preparation of a pharmacovigilance plan indicated in Article 5 and reporting indicated in Article 6.Ģ. The surveillance of pharmaceutical safety in the preceding paragraph shall cover the following:ġ. 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 period designated by the central competent health authority as required by Paragraph 1 of Article 45 of the Act shall be based on the effective period shown on the Drug Permit. These Regulations are established in accordance with Paragraph 2 of Article 45 of the Pharmaceutical Affairs Act (hereinafter referred to as the Act).
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