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Chapter Law Content

Title: Pharmaceutical Affairs Act CH
Category: Ministry of Health and Welfare(衛生福利部)
Chapter X Supplementary Provisions
Article 102
Any physician having dispensation facilities as specified in this Act may, for the purpose of medical treatment, dispense drugs by himself/herself based on his/her own prescriptions.
After two years of the implementation of the National Health Insurance, the provision of the preceding Paragraph shall be enforceable only in the remote areas where practicing pharmaceutical personnel are not available as announced by the central or municipal competent health authorities or in the case of urgent need of medical treatment services.
Article 103
After promulgation of this Act, dealers of Chinese medicines who had applied for and obtained, in record, in accordance with the governing law and regulations before May 31, 1974, a new license in lieu of old one for selling Chinese medicines may continue to operate the business of selling Chinese medicines.
Those who have been duly reviewed and registered by the central competent health authority before February 5, 1993, or have obtained a certificate of Chinese medicine dealer and have received education in Chinese medicine to an appropriate degree, may continue to operate the business of selling Chinese medicines.
The scope of business operations for dealers of Chinese medicines referred to in the preceding Paragraph include: the importation, export, and wholesale of Chinese medicine materials and Chinese medicine preparations; retail of Chinese medicine materials and non-prescription Chinese medicaments;
non-poisonous Chinese medicine materials or traditional pellets, powdered medicine, ointment, pills, or decoct medicines dispensed from preparations of traditional formulas
The scope of business operations for the aforementioned persons, having passed the Chinese medicine doctor examination; and supervisors, with more than three years’ experience at a Chinese pharmaceutical firm which retains a resident Chinese medicine doctor, pharmacist, or assistant pharmacist before retaining a Chinese pharmacist, having studied Chinese medicine to an appropriate level, having obtained licenses from the local health competent authority, and having taken and passed the National Examination; shall be as follows:
1. The importation, export, and wholesale of Chinese medicine materials and Chinese medicine preparations;
2. The retail of Chinese medicine materials and non-prescription Chinese medicaments;
3. Non-poisonous Chinese medicine materials or traditional pellets, powdered medicine, ointment, pills, or decoct medicines dispensed from preparations of traditional formulas; and
4. The dispensation of medicaments prescribed by a Chinese medicine doctor.
The examination referred to in the preceding Paragraph shall be determined by the Examination Yuan in conjunction with the Executive Yuan.
Article 104
The full-time pharmacists or assistants pharmacist retained by western medicine dealers duly approved, registered, and licensed before December 31, 1989, shall not be subject to the resident management requirement set forth in the first Paragraph of Article 28 of this Act.
Article 104-1
The western medicine dealers duly approved, registered, and licensed before December 31, 1989, referred to in the preceding Article, shall refer to owners of pharmaceutical firms who have not changed and are still in business as of January 1, 1990. Pharmaceutical firms registered as retailers which continue to operate under the supervision of the spouse after the death of the original owner, shall not apply.
Article 104-2
Persons who apply for permit license, or formally inquire for the Criteria Governing Registration and Market Approval of Drugs, Criteria Governing Registration and Market Approval of Medical devices, or related regulations, shall be subject to a fee.
The classification and amount of the fee referred to in the preceding Paragraph shall be determined by the central competent health authority.
Article 104-3
When necessary, a competent health authority at any level may designate a subordinate agency or commission a relevant agency (or organization) to conduct all or part of the test checks and inspections. The regulations governing such designation or commissioning and related matters shall be prescribed by the central competent health authority.
Article 104-4
The central competent health authority may carry out certification for the inspection institutions for medicaments inspection operations. The regulations governing their certification and management shall be prescribed by the central competent health authority.
The central competent health authority may designate a subordinate agency or commission another agency (or organization) to carry out the certification of the preceding paragraph. The regulations governing such designation or commissioning and other relevant matters shall be prescribed by the central competent health authority.
Article 105
The Enforcement Rules of this Act shall be established by the central competent health authority.
Article 106
1. This Act becomes effective from the date of promulgation.
2. The enforcement date of Article 53 hereof, which was amended and published on May 7, 1997, shall be set by the Executive Yuan. Articles which have been amended on May 5, 2006 will be enforced as of July 1, 2006.
3. The enforcement date of Chapter 4-1 and Articles 92-1, 100, and 100-1 and 92-2 hereof, which have been amended on December 29, 2017, shall be set by the Executive Yuan.