تشريع الأدوية - معلومات الدورة

Pharmaceutical Legislation & Regulatory Affairs - Course Information

• Course Code: NP (705)
• Program: Pharm. D. Program
• Faculty: Faculty of Pharmacy, Fayoum University
• Year: Fourth year students (2024-2025)
• Coordinator: Hadel Aly, Ph.D.

Practice of Pharmacy Profession

• This section likely details the practice of pharmacy in general.

Law No. 127 of 1955 Regarding the Practice of Pharmacy Profession

• This section likely outlines the specific rules and regulations related to practicing pharmacy as defined by law No. 127 of 1955 in Egypt.

Key Questions about Law No. 127 of 1955 (Questions concerning the law)

• Who is allowed to practice pharmacy?
• What does "practicing pharmacy" entail, according to legal definitions?
• What steps are needed for registration with the Ministry of Health?

Article 1 - Practice Restrictions

• It is forbidden for any individual to practice pharmacy unless they are Egyptian citizens or from a country that permits Egyptians to practice the profession within its borders.
• Individuals must be registered on the Ministry of Health's pharmacy register and on the Pharmacy Syndicate's list.
• The practice of pharmacy includes preparing, compounding, and dispensing any medicine, drug, herbal remedy, or pharmaceutical substance taken internally or externally, or injected, to prevent or cure diseases in humans or animals.

Article 2 - Educational Qualifications

• The qualifications for practicing pharmacy require a bachelor's degree in pharmacy or pharmaceutical chemistry from an Egyptian university or a foreign degree/diploma considered equivalent through successful completion of an examination specified in Article 3.
• Foreign qualifications will be considered equivalent to Egyptian bachelor's degrees by a committee appointed by the Minister of Public Health, comprising at least two professors of pharmacy and a representative from the Ministry of Health.

Article 3 - Foreign Degree Testing

• The examination for foreign degrees/diplomas follows the curriculum of the final examination for an Egyptian bachelor's degree in pharmacy.
• It is administered by a committee of pharmacists chosen by the Minister of Public Health and a representative from the Ministry.
• The applicant submits an application form, certificate, fees, and examination details to the Ministry of Health.

Article 4 - Exemption from Examination

• The Minister of Public Health can exempt Egyptian citizens who have a high school diploma (specific section) and have maintained good conduct and attendance throughout their studies from taking the examination required under Article 3.

Article 5 - Registration Procedures

• For registration in the public health register, an application form, a photo, a certificate, and a receipt for payment of the registration fee are required.
• The name, title, nationality, and place of residence of the pharmacist are included in the register along with their qualification details and the date of the examination (if applicable).
• The Ministry informs the Pharmacy Syndicate of the new registration.
• The pharmacist receives a copy of their registration.

Article 6 - Address Changes

• Pharmacists must notify the Ministry of Health within a week of any change to their address.

Article 7 - Invalid Registrations

• Fraudulent or irregular registrations in the pharmacy register are void and are removed by a decision made by the Ministry of Health and the public prosecutor.
• The Pharmacy Syndicate must inform the Ministry of Health of any disciplinary actions.

Article 8 - Publicly Available Register

• The Ministry of Health publishes a list of licensed pharmacists.

Article 9 - Exceptional Licenses

• The Minister of Public Health, after consulting with the Pharmacy Syndicate, can grant licenses to practice pharmacy to individuals who do not meet the standard qualifications under certain exceptional circumstances.
• These circumstances may relate to exceptional expertise in a particular branch of pharmacy and the need for their services in Egypt. The period of this license is limited, and renewable.

يستعرض هذا الاختبار المعلومات المتعلقة بتشريعات الأدوية وشؤون التنظيم لطلاب السنة الرابعة في برنامج دكتور صيدلي. يتناول أيضا قانون رقم 127 لعام 1955 والذي يحدد القواعد الخاصة بممارسة مهنة الصيدلة في مصر.