[Background]
Expansion of restrictions on pharmacy's unique names and scope of advertising is needed to prevent misleading or enticing consumers, which disrupts the pharmaceutical distribution order.
[Main Points]
A. Submission Requirements for Pharmaceutical Sales to Veterinary Clinics (Proposed Article 48)
Establish the content, method, and deadline for the submission of pharmaceutical sales records by pharmacy owners to veterinary clinic owners.
B. Revision of the Sales Ledger Form for Veterinary Sales (Proposed Form 25)
The name of the ledger form is changed from "Management Ledger of Pharmaceuticals Sold to Veterinary Clinic Owners" to "Current Status of Pharmaceutical Sales Details to Veterinary Clinic Owners." Additional fields are added to the form, including the business registration number, veterinarian's license number, product code, specification, and serial number of the sold pharmaceuticals.
C. Clarification of Disclosure Deadline for Expenditure Reports on Economic Benefits (Proposed Article 44-2)
Clarification of the disclosure deadline for expenditure reports concerning the provision of economic benefits (e.g., to healthcare professionals).
D. Reflecting Terminology Change in the Post-Market Review System (Proposed Attached Table 2)
Reflect the terminology change in the attached table due to the transition of the Post-market Re-examination System (applicable to new drugs) to the Risk Management System (Act No. 20328, promulgated on February 20, 2024, effective on February 21, 2025).
E. Revision of Forms for Pharmaceutical Sales Promoters (Proposed Form 23-6)
Revise the report form for pharmaceutical sales promoters regarding closure, suspension, or resumption of business to enhance administrative convenience for applicants.
F. Revision of Expenditure Report Form for Economic Benefits (Proposed Form 23-9)
Revise the Expenditure Report form to include a column indicating whether economic benefits have been provided. If no economic benefits were provided, the form is revised to allow excluding other related items from the report writing requirement.
G. Expanded Restrictions on Pharmacy Names and Advertisements (Proposed Article 44)
Expand the scope of restrictions on the unique names, displays, and advertisements that pharmacy owners must adhere to, in order to prevent acts that mislead or entice consumers and disrupt the pharmaceutical distribution order.
H. Streamlining Regulatory Review Deadlines (Proposed Articles 21, 60)
Unify overlapping regulatory review deadlines (from 2 and 3 years to 3 years) for consistency in regulations.
