Pharmacy Licensing In Egypt | Requirements Under Law 127 Of 1955

Pharmacies are important public medical facilities with a direct impact on public health and community safety, given their pivotal role in the distribution and dispensing of medicines. This requires strict legal regulation that balances the freedom to practise the profession with the state's duty to supervise and protect public health.

In this regard, Egyptian lawmakers established a specific legislative framework to regulate the establishment, licensing, and operation of pharmacies, starting with Pharmacy Profession Practice Law 127 of 1955 (“Law”), followed by ministerial decrees and executive regulations aimed at establishing clear controls governing pharmacy ownership, licensing conditions, professional responsibilities, and inspection and accountability mechanisms.

This Paper sheds light on the legal system governing the licensing of pharmacies in Egypt, reviewing the relevant laws, the requirements to be met by license applicants and pharmacy locations, and the licensing procedures. The paper also outlines the legal obligations of licensed pharmacies and the penalties imposed in the event of violation of the provisions of the Law, within the framework of a comprehensive legal study that helps investors and pharmacists to practice their activities within a sound and stable legal framework.

• Pharmaceutical institutions are any facilities established for practicing any activity related to the pharmacy profession. This includes the distribution, preparation, storage, or dispensing of pharmaceutical preparations to the public, under the direct supervision of a licensed pharmacist and in accordance with the controls established by Law and the executive regulations issued in implementation thereof.
• Pharmaceutical institutions include public pharmacies, private pharmacies, drug stores, pharmaceutical distribution companies, and drug manufacturers, each of which is subject to specific legal regulations in terms of licensing requirements, nature of activity, and professional and administrative responsibilities.
• Fundamental requirement for giving a pharmaceutical institution legal status is the licensing,

which allows the institution to operate within the limits set by Law, subject to periodic supervision and technical inspection, and compliance with all professional and health rules stipulated by law.

The Egyptian lawmakers regulated the concept of pharmaceutical institutions and legal forms thereof under the Law. The Law stipulates that pharmaceutical activities may only be carried out by institutions licensed by the competent administrative authority, represented by the Ministry of Health and Population, in order to ensure strict control over the circulation of medicines and protect public health.

• Main requirements for licensing pharmaceutical institutions (pharmacies) in Egypt: Under the Law, the Egyptian lawmakers regulated the mandatory requirements for licensing pharmaceutical institutions (pharmacies), which are as follows:
• Requirements relating to the licence applicant (pharmacist):
  1. The profession of pharmacy may only be practised by a person whose name is registered with the Register of Pharmacists at the Ministry of Health and Population, and who are legally licensed to practise the profession.
  2. The pharmacist shall be registered with the Ministry of Health, hold a bachelor's degree in pharmacy, and be registered at the time of applying for the licence.
  3. The pharmacy shall be subject to the direct supervision of a pharmacist. No pharmacy may be operated or managed without a licensed pharmacist in charge, in order to protect public health and prevent the misuse of medicines.
  4. Pharmacists may not own or be licensed to own more than two pharmacies, as specified by Law, in order to prevent monopolisation of the activity and ensure proper supervision.
• Requirements relating to pharmacy location:
  1. Prior authorisation shall be obtained: The Law stipulates that a licence shall be issued by the Ministry of Health and Population before a pharmacy can be established or opened to the public. Any activity carried out before the licence is issued is considered a serious violation that warrants legal accountability.
  2. Fulfilment of health and technical requirements: The following requirements shall be met at the pharmacy's premises in order to obtain a licence:
     • he space shall be suitable for carrying out the activity
     • .Good lighting and ventilation at the place of activity, and availability of health requirements.
     • Appropriate preparation of the place for keeping and storing medicines.
     • Provision of safety and security measures in accordance with medical and health standards.
  3. Legal validity of the property for the activity: The pharmacy premises shall be legally licensed to conduct commercial activities and shall not violate any building, regulatory or usage requirements.
  4. The Egyptian lawmakers set the requirements to observe the legal distances between
  5. pharmacies, as determined by the competent authority, in order to achieve a fair distribution of
  6. pharmaceutical services.
• Procedural and administrative requirements:
  1. A formal application shall be submitted to the competent health directorate, accompanied by the documents specified by Law, which are:
     • A copy of the pharmacist's licence practising the profession.
     • Certificate of registration as a pharmacist with the Pharmacists' Association.
     • The pharmacist's criminal record.
     • Title or rental documents for the pharmacy premises.
     • Approved drawings of the pharmacy premises.
  2. The pharmacy shall be inspected by a specialised committee to ensure that it meets all legal and technical requirements before the final licence is issued.
  3. The licence shall only be issued after payment of the fees specified by Law, which are part of the regulatory procedures for licensing.
• Upon fulfilling all the basic requirements for a pharmacy licence, the licence is issued. The licence is personal and location-specific, issued in the name of the pharmacist and for a specific location. It may not be assigned, transferred, or changed without the approval of the Ministry of Health and Population and in accordance with legal procedures. Any action contrary to this will result in the pharmacist being held legally accountable.
• Documents required for licensing a pharmaceutical institution in Egypt:
  1. An application for a licence to open a pharmacy, as per the form prepared by the relevant Health Affairs Directorate. The application shall contain the main details of the pharmacist and the nature of the premises for which the licence is sought. A postal order for the fee shall be sent to the medical district where the pharmacy is located.
  2. The pharmacist's birth certificate and criminal record certificate, submitted to the medical district where the pharmacy is located.
  3. The pharmacist's valid national ID card, a copy of their professional licence or a copy of their General Association card, and a personal photo.
  4. Certificate confirming the number of pharmacies owned by the pharmacist.
  5. Certificate of approval of the pharmacy's trade name from the branch Association.
  6. Three approved engineering drawings of the pharmacy to be licensed, certified by a union engineer, showing the vertical and horizontal sections of the premises to be licensed, ventilation outlets, the location of the pharmacy, and the location of the nearest licensed pharmacy.
• Upon submission of the documents and payment of the applicable fees, the pharmacy premises will be inspected by the inspection committee to ensure compliance with health and technical requirements before the final licence is issued. Should any observations be made, the pharmacist will be given a specific grace period to rectify the situation before another inspection is conducted.
• At the end of the examination, a report will be issued, stating the Committee's decision to accept or reject the application, and it shall be sent to the licence applicant by registered letter with acknowledgement of receipt.
• Reasons for rejection of licence applications for pharmaceutical institutions:
  1. The application will be rejected if any of the above documents are not attached to the licence application file.
  2. Failure to send documents by registered mail with acknowledgement of receipt.
  3. The criminal record shall not be valid or forwarded to any authority other than the Ministry of Health.
  4. Failure to provide the address of the licence applicant or the address of the institution to be licensed.
  5. Failure to submit three copies of the drawing of the premises.
  6. Failure to send the original birth certificate or criminal record.
  7. Failure to send proof of payment of the examination fee or a postal order.
• Procedures followed after the decision to approve the registration of the pharmacy institution:
  1. The application will be recorded in the pharmacy register under the licence. The register shall be stamped and numbered, and shall not contain any deletions, erasures, or additions. The licence applicant shall be given a receipt with the registration number and the application date in the register.
  2. The competent Pharmacy Administration shall send a letter to the competent district in accordance with the form prepared for that purpose. The name of the pharmacist and the application number in the register of pharmacies under licence shall be written on the envelope.
  3. The initial inspection date shall be set within thirty days from the date of registration of the application in the register of pharmacies under licence with the Pharmacy Administration. The date shall be recorded in the inspection register and in the register of pharmacies under licence. The competent Pharmacy Administration shall announce the inspection dates monthly on the notice board at the Directorate.
  4. The licence applicant shall be notified by registered letter with acknowledgement of receipt of the date of the initial inspection. Upon attendance, the licence applicant shall be given a receipt stating the number and date of registration of the application in the register of pharmacies under licence, specifying the date of the inspection, completing the undertaking details, and recording the date of the initial inspection.
• Role of legal advisors in pharmaceutical institution registration:

Legal advisors play a key role in registering and licensing pharmaceutical institutions, including verifying pharmacists' legal eligibility under the Law, reviewing title deeds, and ensuring that premises meet legal and technical requirements. Their role also includes preparing the licence application and following up on procedures with the relevant authorities. This ensures compliance with the legal requirements for pharmacies, speeds up the licensing process, and reduces legal risks.

In conclusion, the licensing of pharmaceutical institutions in Egypt represents a pivotal step in ensuring the safety of medicine circulation and protecting public health. It requires full compliance with all laws and regulations, including the Law, technical and health requirements for premises, and administrative procedures before the competent authorities. In this context, Sadany & Partners Law Firm plays a key role as a legal and advisory supporter, providing specialised legal advice, preparing and reviewing licensing documents, following up on procedures with the Health Affairs Directorate, and ensuring that all legal and technical requirements are met. With its deep legal expertise, our Firm assists pharmacists and investors in obtaining licences quickly and with full legal certainty, while minimising potential risks and protecting their professional and investment rights.

In this way, we ensure that our clients establish and operate pharmaceutical institutions within a comprehensive legal framework, reflecting compliance with the law and enhancing the confidence of investors and customers alike.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.