The definitions mentioned in Federal Law No. (8) of 2019, referred to in the present Resolution, shall apply. Otherwise, the following words and expressions shall have the meanings assigned thereto respectively, unless the context otherwise requires:
Health Authority: Any federal or local government entity concerned with health affairs in the State.
Product Suspension: Suspension of the circulation or use of the product.
Healthcare Profession: A health profession licensed to be practiced in the State, as determined in Cabinet Resolution No. (20) of 2017, referred to above.
Narcotic Drug: A medical product that contains any of the active ingredients listed in Schedules Nos. (1,2,3 or 4) attached to Federal Law No. (14) of 1995, referred to hereinabove, or listed in INCB Schedules Nos. (I, II, III or IV) annexed to the 1961 Single Convention on Narcotic Drugs, amended by the 1972 Protocol, as amended.    
Psychotropic Substance: A medical product that contains any of the ingredients listed in Schedules Nos. (5,6,7 or 8) attached to Federal Law No. (14) of 1995, referred to hereinabove, or listed in INCB Schedules Nos. (I, II, III or IV) annexed to the Convention on Psychotropic Substances of 1971, as amended.    
Controlled Substances: Narcotic drugs and Psychotropic Substances.
Visiting Pharmacist: A pharmacist licensed in a pharmaceutical establishment or health facility in the State and permitted to work on a part-time basis for another pharmaceutical establishment or health facility; or a pharmacist coming from abroad to practice the pharmacy profession in the State for a specified period, in accordance with the conditions and controls set out in the present Resolution. 
Law: Federal Law No. (8) of 2019 on Medical Products, Pharmacy Profession and Pharmaceutical Establishments.

1. Discounts from the prices set by the Ministry may not be granted, but special prices may be set in the course of applying the drugs dispensing system by the Health Authority, as the case may be, or through the government health insurance schemes.  
2. Special prices may be set in the course of applying the drugs purchase system by the health bodies. In such case, drugs shall be dispensed, depending on the purchase price applicable for the health facility.
3. Without prejudice to the provision of Clause (1) of this Article, pharmacies may be granted a quantity of medical products for free and the granted quantity shall not exceed the percentage of the overall quantity sold to the pharmacy as set by a resolution of the Minister. 

The Body Concerned may suspend the medical product's circulation at public and private health facilities falling within their respective areas of competence, and shall report the same to the Ministry within twenty-four hours from the date of issuance of the suspension decision, on the form designated thereby for such purpose. Accordingly, the Ministry shall take the necessary decision in this regard.   

The medical product shall be brought, possessed or held by any person upon entering the State for personal use in accordance with the conditions and rules set out in Annex No. (1) attached to the present Resolution.

Non-pharmaceutical establishments that are determined under a resolution of the Minister and that are permitted to sell, display, store and circulate Over-the-counter (OTC) medical products shall:
1. Purchase the medical product from the warehouse licensed by the Ministry;
2. Adhere to the types of OTC medical products, according to the classification approved by the Ministry;
3. Obtain the approval of the entity licensing the establishment;
4. Comply with the approved storage conditions as for each product; and
5. Adhere to the price set by the Ministry, if any.

No person may engage in any activity in the field of pharmacy profession or work as a pharmacy technician, unless such a person is duly licensed by the Health Authority, in accordance with the conditions and controls set out in Cabinet Resolution No. (20) of 2017, referred to hereinabove, as amended.

1. Those who are entered in the national record created in the Ministry and the special record created in the Body Concerned shall be pharmacy and pharmacy technician practitioners and shall be licensed to practice the profession in the State.
2. The national and special records shall contain a section for pharmacists and another section for pharmacy technicians.
3. The following data shall be listed in the national and special records:
    a. Personal data of the practitioner;
    b. Data of the license granted to the practitioner;
    c. Current status of the practitioner, i.e. licensed and on the job, his license is expired, etc.); and
    d. Any other data determined by the Health Authority, as the case may be.
4. The national and special records shall be numbered and may be in paper or electronic form.
5. Deletion, scraping or erasing in the national record or special record may not be made, except in accordance with the procedures set by the Health Authority, as the case may be.
6. The national and special records shall be updated on a periodic basis at least once every year.
7. The information contained in the national and special records shall be subject to the information protection system, as decided by the Health Authority, as the case may be, and shall also be subject to the provisions related to maintaining confidentiality in accordance with the legislation in force in this field.
8. Pharmacists and pharmacy technicians shall be classified in the national record into the following categories:
    a. Record of pharmacists and pharmacy technicians working in drug factories;
    b. Record of pharmacists and pharmacy technicians working in pharmaceutical laboratories;
    c. Record of pharmacists and pharmacy technicians working in pharmaceutical consulting firms;
    d. Record of pharmacists and pharmacy technicians working in marketing firms;
    e. Record of pharmacists and pharmacy technicians working in public and private health facilities;
    f. Record of clinical pharmacists working in public and private hospitals;
    g. Record of pharmacists and pharmacy technicians working in public and private health centers;
    h. Record of pharmacists and pharmacy technicians working in pharmacies and medical warehouses; and
    i. Record of pharmacists and pharmacy technicians working in health bodies.

The Health Authority shall, as the case may be, consider and decide on the applications submitted for licensing or renewing the licenses of persons to practice pharmacy profession and pharmacy technician profession in accordance with the controls and conditions set out in Cabinet Resolution No (20) of 2017, referred to hereinabove, as amended.

The following requirements and controls shall be met to issue a temporary license for a visiting pharmacist to practice the profession:
First: The requirements and controls for visiting pharmacists inside the State:
1. He shall be licensed to practice the pharmacy profession in his original employer in the State under a valid license.
2. He shall submit a copy of the certificate of good conduct issued by the Health Authority, proving his good conduct and that no judgment or disciplinary decision has been rendered against him to prevent him from practicing the pharmacy profession or restricting his practice thereof.
3. He shall submit the approval of his employer.
4. He shall meet any other requirements set by the Health Authority, as the case may be, without prejudice to the provisions of the Law and the present Resolution.
Second: The requirements and controls for visiting pharmacists outside the State:
1. He shall submit a certified copy of the certificate of good conduct issued by the state in which he works, proving his good conduct and that no judgment has been rendered against him to prevent him from practicing the pharmacy profession or restricting his practice thereof.
2. He shall submit proof that he practices the pharmacy profession in the state in which he works.
3. He shall submit a copy of the academic qualifications and degrees.
4. He shall meet any other requirements set by the Health Authority, as the case may be, without prejudice to the provisions of the Law and the present Resolution.
The Health Authority may exempt the visiting pharmacist from outside the State from any of the requirements and controls set forth hereinabove, as it deems appropriate.
 

The pharmacist who is licensed to practice the pharmacy profession shall abide by the scope of work and area of activity as defined in the license granted to him to practice the profession in the State. He shall also perform his job duties accurately and honestly as required by his profession, according to the acknowledged scientific and technical principles, and the responsibilities and principles contained in the Approved Code of Ethics and Professional Conduct for Health Professionals.

A pharmacist may provide first aid, provided that he holds a training certificate regarding such aid issued by an accredited body in this field.

In addition to the requirements set forth in Article (49) of the Law, a medical prescription shall:
1. Be written in a non-erasable, unchangeable material if the prescription is written.
2. Contain electronic signature and electronic code if the prescription is electronically printed out.
3. Contain the administration method of the drug or preparation dispensed therein.
4. It has not been issued for more than sixty days, unless it contains controlled substances or products.
5. Contain the patient’s gender.
6. Contain the treatment duration and determine the repetition times, if necessary, even if it exceeds the duration mentioned in Clause (4) of this Article. Drugs may not be dispensed against repeat dispensing prescriptions if thirty days have passed since the date set by the physician for repeat dispensing.
7. Contain the licensing number of the healthcare practitioner who issued the prescription, along with the seal of the health facility, provided that such seal contains the name of the emirate where the facility exists. 

Controlled substances and products may not be dispensed if more than three years that may be extended by a further period have passed since the issuance of the medical prescription, subject to the approval of the Health Authority, as the case may be.

1. A pharmacist may replace a pharmaceutical product with an equivalent pharmaceutical product after giving advice and counseling to the patient in this regard so as to provide an opportunity to the patient to choose the pharmaceutical product he prefers. The pharmacist shall explain to the patient that the equivalent pharmaceutical product contains the same formula of the pharmaceutical product prescribed or previously dispensed.
2. The pharmacist shall, upon replacing a pharmaceutical product with an equivalent pharmaceutical product, take into account the following:
    a. The patient’s consent of the replacement of the product with an equivalent one.
    b. The prescribed pharmaceutical product shall not be one of the narrow therapeutic index drugs, which require accurate monitoring and control of their concentration in blood.
    c. The prescribed pharmaceutical product shall not be one of the narcotic drugs and psychotropic substances or other drugs determined by the Ministry.
    d.The prescribed pharmaceutical product shall not be one of drugs with therapeutic indications.
    e. The prescribed pharmaceutical product shall not be one of the biological and biosimilar drugs, except in case of ensuring the possibility of replacement by the Ministry. 
 

1.    The pharmacist in charge of the custody of controlled and semi-controlled substances and products shall enter the dispensed medical prescriptions of such substances in the records determined by the Minister, in accordance with the following controls and requirements:
    a. All controlled and semi-controlled substances and products shall be entered in a special record for all of such products, provided that the dispensing of each item is recorded in separate pages, taking into account that a sufficient number of pages is dedicated to each item as for paper records and the product is not recorded in separate pages. The pharmacist shall, when necessary, write the page and record numbers as an indication of the stock shown in the page.
    b. The drug scientific name and trade name, concentration and pharmaceutical form shall be listed at the top of each page of the records.
    c. The data shall be listed in chronological order, provided that the date of each transaction is clear and the data are listed on the day of the transaction, along with the signature to this effect.
    d. The ink used in writing data on the pages of the paper record shall be indelible.
    e. No amendment, scraping or deletion shall be made to any of the data contained in the record. If it is necessary to make any correction, a comment or note shall be written in the “notes” column in the record, then the correct data shall be written in the next line. 
    f. The custody officer shall keep the record in a safe place at the facility, provided that it is available for inspection at any time. A separate record shall be kept for each facility.
2. The controls and requirements set forth in Clause (1) of this Article shall be observed as for electronic records, in accordance with the requirements and characteristics of electronic formats of the record, provided that it includes, in particular, the characteristics of back-up and tracking of any change or amendment to the data, in addition to the conditions set forth in Federal Law No. (2) of 2019, referred to hereinabove, and the Executive Regulations thereof.
3. The period of keeping the records, referred to in this Article, shall be specified by a resolution of the Minister.  

The license for starting up a pharmaceutical establishment shall be valid for at least one year, renewal for a similar term, upon a request to be submitted for such purpose.

Subject to the approval of the Health Authority, as the case may be, ownership of the pharmaceutical establishment may be assigned to third parties, in accordance with the following conditions:
1. Verifying the conditions related to the transfer of ownership;
2. Submitting the duly certified assignment documents; and
3. Submitting proof of settlement of any financial claims on the pharmaceutical establishment to the licensing authority or the insurers.  
 

The following violations shall be deemed serious violations. The Health Authority may, as the case may be, issue a decision on the temporary closure of the pharmacy for a period not exceeding one month in case of performing any of the following actions:
1. Failure to comply with the recall and suspension decisions of some medical products issued by the Health Authority, as the case may be;
2. Circulation of medical products purchased from non-licensed bodies;
3. Absenteeism of the pharmacist who is in charge of the pharmacy and practice of the pharmacy profession by persons who are not licensed;
4. Dispensing of controlled or semi-controlled drugs in an illegal manner;
5. Sale of expired, counterfeit or smuggled medical products or those products failing to get marketing authorization from the Ministry if this is necessary or if their expiry date or any of the data written on the package have been manipulated;
6. Forgery of the documents related to the medical products;
7. Failure to comply with the health or technical requirements set by the Health Authority, as the case may be, and repetition of the violations; or
8. Practice of the activity before obtaining the final license.   
 

The following violations shall be deemed serious violations. The Health Authority may, as the case may be, issue a decision on the revocation of the pharmacy’s license in case of performing any of the following actions:
1. Manipulation in the records of controlled or semi-controlled drugs and circulation of the same in a manner contrary to the legislation in force in the State;
2. Repetition of manipulation of the expiry date of the medical products with the precedent of temporary closure if the establishment because of that;
3. Continuation of the practice of the activity after the expiry of the time limit for renewal of the license as determined by the legislation in force in this regard;
4. Transfer of ownership of the pharmacy, subject of the license, to another person without obtaining the approval of the Health Authority, as the case may be; or
5. Failure to implement the directives of the Health Authority, as the case may be, to correct the violations related to the health and technical requirements, because of which the pharmacy has been temporarily closed.
 

In case of absenteeism of the pharmacist who is in charge of the management of the pharmacy, the pharmacy owner shall assign its management and supervision over it to another pharmacist licensed to practice the pharmacy profession to act as another pharmacist existing in the same pharmacy or another licensed pharmacy within the same emirate. The owner may also assign the same to a visiting pharmacist, provided that a pharmacy technician exists in the pharmacy. In all cases, the period of absenteeism shall not exceed three months, whether consecutive or non-consecutive, over the year.    

A license may be issued for starting up more than one Pharmacy in accordance with the pharmacy chain system, provided that the following requirements are satisfied:
1. The number of pharmacies within the chain shall be within the limits permitted by the Health Authority, as the case may be.
2. The pharmacies within the chain shall be owned by one natural or legal person.
3. All pharmacies within the chain shall obtain a separate license for the establishment and shall satisfy the health and technical requirements and the required controls.
4. In case of adding one or more pharmacy owned by another person(s) to the pharmacy chain, the necessary actions shall be taken with the competent authorities in the State to transfer their ownership to the owner of the chain before licensing the addition thereto.
 

1. Without prejudice to the provision of Article (10) of this Resolution, a pharmacy may not be used as a medical clinic or for any other purpose and its work shall be restricted to the following activities:
a. Storage, display, dispensing and sale of medical products, including food and milk for infants and young children; and
b. Composition or preparation of medical products in accordance with the legislation in force in this regard.
2. In addition to the activities set forth in Clause (1) of this Article, the pharmacy may perform the following sub-activities:
    a. Storage, display, dispensing and sale of medical supplies for personal use;
    b. Measurement of weight, height, blood pressure or temperature or conducting a finger-prick blood sugar test or any other tests decided by the Health Authority, as the case may be, for the purpose of providing advice and guidance to the patient, without diagnosing the health condition;
    c. Provision of pharmaceutical education services to the person who inquires about the method of use of medical products;
    d. Storage, display, dispensing and sale of dietary supplements;
    e. Storage, display, dispensing and sale of household insecticide products;
    f. Sale of cosmetics and perfume; and
    g. Any other activities determined by a resolution of the Minister.
 

The Health Authority may, as the case may be, may issue a license for starting up private pharmacies affiliated to a governmental non-healthcare body, a public establishment or associations or organizations of public welfare, or the private hospitals and medical centers, provided that the following requirements are satisfied:
1. A license application shall be submitted to the Health Authority, as the case may be.
2. The pharmacy shall be managed by a licensed pharmacist.
3. The pharmacy shall satisfy the technical and health requirements necessary for the operation thereof, with the possible exception of any of such requirements as determined by the Health Authority, as the case may be.
4. The pharmacy shall not provide its services to the public and its area of activity shall be limited to the employees of the body to which the pharmacy is affiliated or the beneficiaries of the services of such body.
The body to which the pharmacy is affiliated shall set the work rules of the pharmacy, provided that such rules are not contrary to the provisions of the Law and the present Resolution.
 

The medical warehouse shall satisfy the technical and health requirements set out in Annex No. (2) attached to the present Resolution.

The following violations shall be deemed serious violations. The Licensing Authority may, within its scope of competence, issue a resolution either to close the Medical Warehouse on precautionary grounds or to suspend its license temporarily in case of performing any of the following actions:
1. Practice of the activity before obtaining the license;
2. Circulation of counterfeit, falsified or defective products;
3. Failure to comply with the decisions on recall or suspension of circulation of some medical products;
4. Circulation of medical products purchased from non-licensed bodies without obtaining the approval of the Ministry;
5. Absenteeism of the pharmacist in charge of the warehouse and practice of the pharmacy profession by non-licensed persons;
6. Failure to comply with the rules and controls related to the circulation of controlled and semi-controlled substances and products or precursor chemicals or those related to the relevant records;
7. Circulation of medical products from companies not registered with the body in charge of registration in the State without obtaining a permission from the Ministry;
8. Breach of the technical and health requirements for starting up a medical warehouse;
9. Failure to implement the recommendations related to the violations committed by the warehouse; and
10.Manipulation in the documents or data written on the package of the medical product, such as the expiry date, etc.
 

The following violations shall be deemed serious violations. The Licensing Authority may, within its scope of competence, issue a resolution to revoke the license of the Medical Warehouse in case of performing any of the following actions:
1. Manipulation in the records of controlled and semi-controlled drugs and precursor chemicals;
2. Repetition of manipulation of the expiry date of the medical products with the precedent of previous notice and temporary closure for the same reason; 
3. Continuation of the practice of the activity after the expiry of the time limit for renewal of the license as determined by the legislation in force in this regard; or
4. Repetition of any of the violations set forth in Paragraphs (b), (c) and (d) of Clause (1) of Article (70) of the Law for more than two times in a year.
 

Pharmaceutical consulting firms shall be competent to:
1. Provide strategic guidance to pharmaceutical establishments;
2. Provide good management advice in the pharmaceutical field;
3. Provide professional training and development in the pharmaceutical field;
4. Provide consultations in the development of medical products;
5. Provide consultations in the field of studies, researches and management of pharmaceutical projects;
6. Provide consultations related to pharmacovigilance and the safety of pharmaceutical products; 
7. Provide consultations related to the quality of the services of the pharmaceutical establishments and pharmaceutical products;
8. Provide consultations regarding the satisfaction of the licensing conditions and the applications for the licenses necessary for the pharmaceutical establishments;
9. Provide advice regarding the Good Manufacturing Practice for factories and assist them to obtain the required approval certificates; and
10. Provide consultations in the following fields:
    a. Marketing and circulation of pharmaceutical products;
    b. Studies related to the prices and costs of medical products;
    c. Satisfaction of the conditions and procedures for marketing approval of medical products; and
    d. Any other studies and advice necessary for the smooth operation in pharmaceutical establishments.   
 

The person in charge of the pharmaceutical laboratory or research center shall be qualified, available on a full-time basis for technical supervision and licensed in accordance with the following conditions:
1. He shall hold an academic qualification from one of the universities or centers recognized in the State in any of the following specializations: pharmacy, one of the specializations of chemistry, microbiology or other relevant disciplines.
2. He shall have at least five years of experience in the area of specialization. 
 

The following violations shall be deemed serious violations. The Ministry may, on its own and in coordination with the Competent Bodies or based on the recommendation of the Competent Bodies, issue a resolution either to close the factory on precautionary grounds or to suspend its license temporarily in case of performing any of the following actions:
1. Establishment of repetition of the factory’s failure to apply the basis of Good Manufacturing Practice in a manner that affects the quality and safety of the medical product and the public health although a notice is served thereupon;
2. Establishment of non-safety of the products of the factory;
3. Repetition of non-conformity of the product to the approved quality standards upon conducting the laboratory examinations to be performed at the accredited laboratories in the State although a notice is served thereupon;
4. Concealing any information related to the quality of its products and failure to notify the Ministry immediately upon being aware of the same;
5. Failure to comply with the rules and controls related to the circulation of controlled and semi-controlled substances and products or precursor chemicals or those related to the relevant records; or
6. Establishment of failure to observe the waste disposal best practice, posing a risk to the public health.
 

The licensed physician (anesthesiologist or surgeon) may possess controlled substances and products to be used for the purposes of his/her professional duties within the following quantities:
First: Health Facilities with no internal pharmacy: 
1. For Narcotic Substances: Based on the standard quota approved by the Health Authority in accordance with number of patients receiving treatment and dosages recognized, provided that the quantity shall not exceed the threshold needed to cover the needs of use for a maximum period of two months.
2. The standard stock of narcotic drugs may be replenished more than once within a single month from the medical warehouses, provided that there is a proportion between the standard stock and expected monthly usage (one to three times per month). The standard quota shall be reviewed and amended on a case-by-case basis for each establishment whenever required, based on two former quarterly consumption reports for each establishment.
3. For Psychotropic Substances: In accordance with the quantity used based on the number of patients treated with the controlled drug, provided that the quantity shall not exceed the threshold required to cover the needs of use for a maximum period of two months.
4. In all cases, the physician shall abide by the applicable laws and resolutions on storage of controlled substances and products and shall record the same in the official register, subject to the provisions of Article (15) of this Resolution.
Second: Health Facilities having an internal pharmacy:
The physician of such facilities may not possess controlled substances and products.
 

The following requirements shall apply as a prerequisite for completing the customs clearance procedures for any import shipment containing controlled substances and products or raw materials involved in the manufacturing of controlled substances and products:
1. An import license and import permission shall be issued by the Ministry for private facilities. For government entities, however, only an import license issued the ministry shall be sufficient.
2. A document shall be submitted to prove that the substances imported are conforming to the documents of shipment and labels placed thereon. 
3. The approval of the Ministry’s inspector at the border crossing points shall be obtained for importing controlled substances or products contained in the shipment after ensuring that they satisfy the conditions applicable in this regard and are conforming to the shipment documents.
4. The pharmacist in charge of the entity applying for import shall be present for receiving the shipment, while the Ministry’s inspector shall also be present.
5. A duly authorized representative shall be present in case the import application is submitted directly by the government entities, as well as a representative of Clearance Company. In case the import application is submitted by licensed medical warehouses, the pharmacist in charge of controlled substances and products at the warehouse as well as the Ministry’s inspector shall both be present.
 

In case the holder of a license for possession of controlled substances and products ceases to operate or where the person in charge of its custody gives up the same for whatever reason, the license holder shall take appropriate actions for conducting an inventory count on such controlled substances and products and initiating the handover procedures of the same as follows:  
1. In case the holder of a license for possession of controlled substances and products ceases to operate, the license issuer shall be duly notified. In case such controlled substances and products are narcotic substances, the Ministry as well as the license issuer shall both be notified. In addition, an inventory count shall be conducted on the controlled substances and products and their quantities shall be counted by the custody officer in order to be delivered back to the medical warehouse concerned with such controlled substances and products. However, the possession of psychotropic substances may be transferred to any other branch of the same establishment and the license issuer shall be notified of the same.
2. In the event that the custody officer of controlled substances or products gives up the same, a deed of clearance shall be furnished together with a letter from the employer establishment to the license issuer. If such controlled substances and products are narcotics, the Ministry as well as the license issuer shall both be notified. The notice shall include the date of clearance and shall be signed by the owner or manager of the establishment and stamped with the seal of the establishment, and shall be accompanied by a record of handover of the custody the a new custody officer licensed to possess controlled substances or products, along with a detailed statement of the remaining quantities of such controlled substances or products at the establishment.
3. In the event that the custody officer of controlled substances or products gives up the same in the absence of a substitute officer, the manager of the establishment shall lay hold of and shall not permit the controlled substances or products to be used, and shall notify both the Ministry and relevant Health Authority within two business days in order to approve their delivery back to the medical warehouses concerned with such controlled substances or products. In addition, the psychotropic substances may be transferred to any branch of the same establishment.   
4. The Ministry and / or relevant Health Authority shall review the custody of controlled substances or products in order to approve their handover to the new custody officer or their return to medical warehouses or domestic agents. In all cases, the Ministry shall be notified.
 

1. The Ministry shall, in coordination with the relevant Health Authority, create and periodically update a list of products of strategic medical stock, in order to ensure that the necessary medical products are made available to meet the society’s needs on a permanent basis.
2. Pharmaceutical establishments shall make the products included in the strategic medical stock list available, in order to ensure permanent availability of basic or necessary drugs at medical warehouses and pharmacies of public and private hospitals in quantities that are proportional to the patients’ needs. The Health Authority shall monitor the balances of products included in the strategic medical stock according to appropriate mechanisms.
3. The holder of marketing right, or its representative in the State, shall, on a permanent basis, provide the drugs that have the marketing priority in the State, particular life-saving drugs, whether brand-name or generic drugs, through both maintaining a sufficient stock of them at the medical warehouses in the State and distributing the necessary quantities to the licensed pharmacies in all emirates of the State based on their respective orders.
4. The holder of marketing right, or its representative in the State, shall make available the pharmaceutical products and medical supplies that fall within the scope of its business, under an undertaking to be enclosed with each application for product marketing approval and also upon submitting each marketing renewal application.            
5. The holder of marketing right, or its representative in the State, shall take all necessary precautionary measures in order to ensure permanent availability of the medical products referred to in this State within the State.
6. If a particular medical product cannot be imported for any reason beyond the reasonable control of the holder of marketing right or its representative in the State, either of them shall forthwith notify the Ministry and take the necessary actions for managing the stock at its warehouses in the State in the best manner that is beneficial to the largest number of patients, and shall also take necessary actions for making the underlying product available in the State as soon as possible once the reasons impeding its important cease to exist.
7. If the representative of marketing right holder fails to make the products referred to in this Article available, the same shall notify the Ministry of the same. In which case, the Ministry may permit any other licensed medical warehouse or government entity to have the same product imported through any other licensed importer, provided that the underlying product shall be sold to the public at the same market price or at a fixed price under a mechanism to be established by the Ministry, or to provide a substitute product. 
8. The ministry may permit that the drugs having the marketing approval be imported by any medical warehouse to satisfy the requirements of drug security in the State.
9. The Ministry shall, in coordination with the Ministry of Economy, reserve the right to revoke the marketing approval of the medical products referred to in this Article, if such products are not available in the State without necessary justifications, in respect of the medical products carrying exclusive agencies issued by Ministry of Economy.

The donation of medical products shall be subject to the following controls and conditions:
1. Donation shall take place for the benefit of charities, government entities, public institutions or public welfare organizations or directly to persons whose medical condition requires such products and who have a valid medical prescription yet are falling short of the funds needed to acquire them. 
2. A relevant permit shall be obtained from the Health Authority.
3. The donation shall satisfy the requirements and criteria established to ensure quality and validity of the medical product throughout all circulation phases, starting from its release by the donor until it reaches the hands of the donee.
4. If the donee does not belong to the persons to whom the drug is to be prescribed as an end consumer, the same shall satisfy the storage and safekeeping requirements that ensure validity of the medical product until it is released to the end consumer.
5. If the donation process involves controlled substances or products, the Ministry’s approval shall be obtained beforehand.
6. The medical products donated shall both be valid for use and have a future expiry date of not less than six (6) months.
7. Donations made by individuals shall only be permitted after the underlying drugs are duly evaluated by the competent department or the competent entity, as the case may be.
8. Drugs that are opened or partly used may not be accepted for donation.
9. The medical products permitted to be accepted from individual donors shall be holding a marketing approval in the State, and the batch required to be donated shall be imported under an official permission from the Ministry, shall be stored under the temperatures recommended on their outer packages and may not belong to the controlled substances or products category.
10. If the medical products are intended to be donated for the benefit of charities or public welfare organizations, the storage conditions at the latter shall be verified beforehand, in order to ensure quality and validity of the product donated.
11. Any other controls to be determined under a resolution of the Minister in coordination with the competent entities.

In the course of carrying out maintenance for a pharmacy, the following conditions and controls shall be observed to ensure quality and validity of the medical products:
1. The medical products may not be vulnerable to any factors that might adversely affect their quality and safe use. Failing which, the medical products available at the pharmacy shall be relocated to any other place that satisfies the requirements of ensuring their quality and validity, provided that the Health Authority shall, as the case may be, approve the relocation mechanism and storage location before the relocation actions start. Should the pharmacy contain controlled substances or products, the Health Authority shall, as the case may be, shall be notified of the same. In addition, such products may be delivered back to the relevant medical warehouse subject to prior approval of the Ministry.
2. Once the maintenance work is completed, the Health Authority shall, as the case may be, shall be notified. However, the medical products may only be placed at the pharmacy following their maintenance after the pharmacy is inspected in order to ensure satisfaction of re-operation requirements.
3. Any other controls to be determined based on a resolution of the Minister.
 

Under a resolution of the Minister and subject to coordination with the remaining health authorities, the provisions of Annex No. (1) and Annex No. (2) attached to this Resolution may be amended.

All bodies governed by the provisions of this Resolution shall adjust their respective affairs in conformity with the provisions hereof, not later than six (6) months of its issuance date.  

The Minister shall issue any other resolutions deemed necessary for implementing the provisions of this Resolution.

Any other provision that goes against or conflicts with the provisions of this Resolution shall be repealed.

This resolution shall be published in the Official Gazette and shall enter into force of the day following its publication date.