Marketing, Manufacturing, Packaging & Labeling, Advertising
All legal aspects surrounding marketing, manufacturing, packaging & labeling, and advertising in Egypt. Prepared in association with Youssry Saleh Law Firm, a leading global law firm, this is an extract from The Pharma Legal Handbook: Egypt, available to purchase here for GBP 75.
1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over the-counter medications, and other medicinal products?
The authorization process of marketing new drugs and any medicinal products are as follows:
An application for obtaining a marketing authorization for pharmaceuticals is submitted to CAPA.
The Pharmacy Law No. 127 of the year 1955 provides that a marketing authorization for pharmaceuticals is limited to local manufacturing facilities, foreign manufacturing facilities, agents for foreign manufacturing facilities and individual medical professionals.
An application can only be accepted if there is availability in the relevant box of pharmaceuticals with similar specifications. Ministry of Health Decree 425 of the year 2015 stipulates that the maximum number of pharmaceuticals with similar active ingredients and specifications is 12, including the original (innovative) pharmaceutical. In general, only one imported product is allowed for each box. The number of imported products increases to five for pharmaceuticals requiring complex technology not commonly available in Egypt. Pharmaceuticals are registered in the country of origin or any of the recognized reference countries. In case of the non-recognized reference country, such a registration will be more complex and lengthier.
The applicant must submit an inquiry to CAPA on the availability of a place in the box of similar pharmaceuticals. If there is no space in this box, the request is registered on a waiting list. On confirming that there is a place in the box, the applicant must submit the required documents for determining the commercial name of the pharmaceutical and its price. After then, the application is reviewed by the different technical committees at CAPA.
The applicant must manufacture a pilot batch for testing purposes in respect of locally manufactured pharmaceuticals. For imported pharmaceuticals, random samples are tested by CAPA. CAPA can choose to inspect the local or foreign manufacturing facility before issuing the marketing authorization.
The standard timeframe for obtaining a marketing authorization is about two years. CAPA recently introduced a fast-track registration process.
The marketing authorization holder must notify CAPA with the names of its distributors and confirmation that the distributors apply good supply practices and good manufacturing practices rules. The marketing authorization holder must complete stability studies for the first three production batches in respect of locally manufactured products. The marketing authorization will be cancelled if the holder fails to start production or importing within 18 months from the date of issue of the marketing authorization. The marketing authorization will also be cancelled if the holder fails to produce or import the relevant pharmaceuticals for a continuous period of two years.
The authorization process of the biological products in accordance to Decree No. 297 of the year 2009 shall be as follows:
The applicant must submit a query application about the product concerning the group of alternative drugs to the CAPA. The query application shall include active ingredient, concentration, indications, dosage form & manufacturing company. This application will be recorded according to the date and the hour of presentation. The query applicant is notified with the product situation within fifteen working days of application receipt. After approving the query application, the requested documents will be declared for the pricing determination and will be submitted to the CAPA within thirty working days from the date of reply on the query application or else the query entry number is considered cancelled. The product will be priced – whether local or imported – in a period of maximum sixty working days from the date of receipt of the completion of the pricing file.
After pricing, the preparation is directed to scientific committees in the following cases:
- If it contains a new active ingredient, a new formulation or doesn’t have scientific reference;
- If it has a new indication, a new concentration or a new dosage form; or
- If any international warnings were declared concerning the formula presented for registration.
In the above-mentioned cases the registration applicant is notified to present the scientific studies of the product within thirty working days from the pricing date. Submission is made to the scientific committees within sixty working days from the date of receipt of complete scientific file.
The procedures of product registrations are to be continued in case of approval from the scientific aspect. However, in the case of disapproval, submission is made to the technical committee of drug control to take the appropriate decision.
2. What is the authorization process for the marketing of generic versions of these products?
The authorization of Pharmaceuticals in Egypt follows the “Box” system whereby the box shall not exceed 12 products classified as 1 brand or innovator product and 11 generic products. If there is no space in the box, the request shall be registered on a waiting list.
Concerning products that need high manufacturing technology not available in Egyptian factories, the number of products included in the Box is 12 products including the brand or innovator product and 5 generic products.
After the confirmation of the Box, the applicant must submit the required documents for determining the trade name of the pharmaceutical and its price. Then the application will be reviewed by the Technical Committees at the CAPA. The imported pharmaceutical products (generic) random samples will be tested by the CAPA. The CAPA can choose the inspection of the local manufacture or the foreign before issuing the marketing authorizations.
The average timeframe for the marketing is two years. CAPA introduced recently a fast-track registration process.
The marketing authorization holder must submit to the CAPA the name of the distributors and a confirmation that the distributors apply the GMP rules.
3. What are the typical fees for marketing approval?
The typical fees for marketing approval that does not exceed 10,000 EGP upon each advertisement according to decree no 26 of the year 2009.
4. What is the period of authorization and the renewal process?
The period of authorization is 10 years and then it must be renewed at the CAPA within the last year of the 10 years.
Human pharmaceutical preparations shall be re-registered every ten years upon a request from the owner of the preparation to the General Directorate of Registration in the last year of the validity of the registration notice, provided that the re-registration applicant shall submit a preliminary file for re-registration containing the documents approved by the General Directorate for registration.
Meeting the requirements of the Egyptian Pharmacovigilance Center EPVC, and to fulfill all the requirements of the final file for re-registration, all within a period not exceeding three and a half years from:
- The expiry date of the registration notification or the date of issuance of the approval of the procedure for re-registration or the date of the approval of the Technical Committee for Drug Control, whichever is newer, in the case of preparations that have a scientific reference.
- The date of the approval of scientific committees or the technical committee for Drug Control on the product, whichever is newer, in the case of preparations that do not have a scientific reference. It is permitted to produce, import and trade the product with a temporary license from the General Administration for registration until the end of the three and a half years. At the end of this period and failure to meet the requirements of the final file for re-registration, the product shall be given an additional six months to complete the re-registration process. In addition, if the requirements of the final file for re-registration are not met during the additional six months, the registration of the product is canceled. The provisions of the preceding paragraph shall apply to the preparations already made or to be submitted for re-registration. The product shall be referred to the scientific committees. In the case of non-approval, the technical committee for drug control shall take the decision it deems appropriate, the re-registration procedures shall be completed, the internal publications shall be updated, and the stability study of the product shall be evaluated within 60 working days from the date of submission of the full stability study. Evaluations of availability, bioequivalence and melting rate studies shall be conducted within 30 working days from the date of submission of the completed study. In accordance with the rules and procedures governing the studies of bioavailability, bioequivalence and melting rate studies. The General Directorate of Pharmaceutical Inspection shall withdraw samples in the case of a bioequivalence study. The technical committee for drug control shall present it within 60 working days from the date of completing the re-registration file. In the case of approval, the registration shall be re-registered for a period of ten years with the same registration number in the event of no change of the active substances or of any kind. In case the company changed the activity substances whether in quantity or kind, then all kinds of measures are taken to register as a new product. If the registration period of the product has expired without submitting the re-registration file within the last year of the validity of the registration notice, the registration of the product will be expired.
5. What are the requirements, if any, for post-approval pharmacovigilance?
The marketing authorization holder must have a pharmacovigilance system in order to impose analysis and monitor the effects of medical drugs which have been licensed for human use, and the marketing authorization holder must inform CAPA of any adverse effect of their licensed drugs not later than 15 days from becoming aware of them.
6. Are foreign marketing authorizations recognized?
A separate marketing authorization is obtained from CAPA. The Ministry of Health recognizes foreign marketing authorizations issued by foreign competent authorities such as the European Medicines Agency, the US Food and Drug Administration, the Australian Therapeutic Goods Administration and the Japanese Ministry of Health, Labor and Welfare.
7. Are parallel imports of medicines or devices allowed?
Parallel import is not allowed in Egypt. An importer of any pharmaceutical must be registered in a special importers’ ledger at the Ministry of Health. Registration requires an appointment letter from the market authorization holder. This requirement grants marketing authorization holders control over parallel imports.
However, there is unauthorized parallel importation of pharmaceuticals into Egypt, especially from Gulf countries.
8. What are the restrictions on marketing practices such as gifts, sponsorships, consultancy agreements, travel and entertainment, or other incentives for healthcare organizations and individual medical practitioners?
According to the Ministry of Health Decree No. 238 of the year 2003 stipulating Medical Profession Ethics prohibits medical professionals, it is impermissible to trade in the samples of the medicines and in the pharmaceutical preparations, made ready for publicity purposes, or put them down for sale. The possession thereof is also impermissible for any organizations other than pharmaceutical organizations, which are authorized to import or manufacture them. It is impermissible for the middlemen to keep the medicines samples in any place other than the depot where they have been authorized. Moreover, it is a must to have printed on the internet and external labels of the sample in a clear manner the phrase ‘free medical sample’.
Moreover, the Egyptian Penal Code criminalizes bribery, including facilitation payments. There is no legislation similar to the US Foreign Corrupt Practices Act or the UK Bribery Act, which covers auditing of corporation accounts, self-reporting and self-investigation anti-bribery obligations, nevertheless, the Egyptian Law regulated the bribery in limited cases such as penalizing public officials who committed or engaged in bribery acts committed in Egypt. However, the Egyptian Penal Code provided an exemption from punishment privilege for those who admits the bribery act before the issuance of the judgement, as it is considered a cooperation with the Administrative Prosecution for facilitating the conviction of the relevant public official.
9. How is the manufacturing of medicines and devices regulated and by which agencies?
The manufacturer must obtain a general manufacturing operational license from the Industrial Development Authority and the manufacturing facility must be registered in the industrial register. Then, the company must obtain a license from CAPA at the Ministry of Health.
Conditions of the CAPA license:
- Due registration of the company with the competent Egyptian authority;
- Valid possession of a manufacturing facility;
- Valid operational license for the manufacturing facility from the Industrial Development Authority; and
- Compliance of the manufacturing facility’s design with CAPA technical requirements.
Required documents to be submitted before the obtainment of the license:
- Statement about the machinery to be used;
- Statement about the laboratory equipment;
- Staffing structure; and
- Site master file.
10. Are local manufacturing requirements compatible with Good Manufacturing Practices (GMPs) as defined by the U.S. Food & Drug Administration and/or the European Medicines Agency?
Yes, as Egypt applies the GMP guidelines issued by the World Health Organization “WHO” as per Article 1 of the MOH Ministerial Decree No. 539 of the year 2007. In case of the non-compliance of the WHO’s GMP, a grace period will be provided to the Company in order to reinstitute in accordance with the guidelines. In case the Company did not reinstitute, the Technical Committee will review the issue in order to take all the requisite procedures. However, in case of severe non-compliance in accordance to the non-compliance mentioned in the guidelines, the production will be suspended and cannot be resumed unless the Company complies with the GMP guidelines and the approval of the Technical Committee. In case of reoccurrence of the violation, the Technical Committee can cancel the production license.
11. What is the inspection regime for manufacturing facilities?
There is a department called manufacturing site inspection, which is responsible for ensuring that manufacturing companies are following regulations, legislations and GMP guidelines on their processes for manufacturing of medicines for human and veterinary use. The department ensures that all pharmaceutical products that are introduced to the Egyptian markets are safe, effective and have the best quality.
12. Are manufacturing facilities open for inspection by foreign inspectors or third-party inspectors as authorized by the FDA/EMA?
No, as per the internal regulations of the Central Administration of Pharmaceutical Affairs (CAPA) department at the Ministry of Health, such department forms a committee to inspect and evaluate the Manufacture in accordance to the GMP.
13. What are the requirements for storage, packaging, and handling of medicines and devices and their constituent components?
Storage of the Medicines and Devices:
In order to license the establishment of pharmaceutical institution, each of the following requirements shall be fulfilled:
- The premises shall be established from modern nonflammable construction materials that comply with the Egyptian Standard Specifications, provided that the net height between the ground of the pharmaceutical institution and the bottom of the soffit shall not be less than 2.6 meters.
- The premises ground shall be in the same level of its neighboring land with an exception to undertaking the sufficient necessary precautions to prevent water leakage to the pharmaceutical institution, including providing sewage network, on condition that it shall not violate the patient’s safety during entering and exiting from the pharmacy. In all circumstances, the pharmaceutical institution shall not be established in the basement.
- Walls shall be covered with materials easy to be cleaned to prevent bacterial growth.
- The pharmaceutical institution shall be supplied with a public clean water resource so that water can be withdrawn from upside through a tap that is installed inside the premises above the basin via filter.
- The warehouse where the pharmaceutical products are stored shall fulfill the good storage practices in terms of:
a. Maintaining the temperature and humidity imposed by the specifications of drugs and pharmaceuticals in addition to installing indicators in a visible location in the institution to measure both of them and record the measurements on fixed periods during the working hours, on condition that temperature degrees shall not exceed 30 °C and the pharmacist shall record the measurement regularly.
b. Providing the warehouse with a refrigerator provided with freezer and a thermometer in order to maintain the pharmaceuticals that need a temperature lower than the room temperature in addition to recording the measurement regularly.
c. Allocating a safe and airtight place for psychotropic and narcotic drugs.
d. Allocating a separate place for storing the expired medical products away from the other utilized medical products until the elimination of such products or returning such products back to the producing company by virtue of approved documents taking into consideration the coordination with the competent health authority, provided that a sign, clearly indicating that such products are expired drugs that shall not be used, shall be put on such place.
e. Disposing of pharmaceutical waste in a safe and sound manner that does not constitute any danger to the environment or endanger society’s health.
- Allocating a suitable place in the pharmacy to discuss secretly with the patient the matters related to the pharmacotherapy prescribed to the patient, in addition to making sure that the patient is fully aware of the sufficient information concerning the best use of the drug as well as the method of storing it, the side effects of the drug, and the safest way to dispose of the drug in case the patient did not complete the treatment schedule.
- Providing an access to the internet and the usage of a special program on the computer to keep the records, prescriptions, and all the data of the pharmaceutical institution in order to obtain any of such information when requested, also to keep the receipts and documents evidencing the ingoing and outgoing drugs for five years at least.
- Providing a permanent electricity current at the premises.
- Hanging a fixed banner on the front of the pharmaceutical institution indicating the name of the pharmaceutical institution and the name of its owner.
- Disposing of waste in public sewage according to the engineering drawing approved by the competent health authority, so if there is no public sewerage on 30 meters then the drainage shall be carried out in a separate tank that is built in a vacant land that belongs to the owner and outside the buildings pursuant to the approved engineering drawing.
Manholes and septic tanks shall be covered with tight iron lids, yet they shall be ventilated through a four-inch pipe that is at least two meters high from the surrounding and the corresponding surfaces, and its upper opening shall be covered with a narrow-weaved wire to prevent the entrance of insects.
Tanks shall have separate entrances so that scavenging a tank shall not necessitate passing through any of the rooms of the pharmaceutical establishment. They shall also be as far as two meters at least from the walls, unless the tank is not impervious, in such a case, the above-stated requirement of the distance between the tanks and the walls may be waived.
If the public sewer is approaching 30 meters or less from the pharmaceutical institution, the sewerage must be connected to it and the existing tanks should be filled and crushed.
The basins on gully trap and it should be drained over the public sewer and gullytrap and the inspection rooms should be located in a space outside the pharmaceutical establishment.
It is not permissible to find any tank or inspection room or a telescope under the eye’s surface, and no sewer dispensers, drains, or toilets can be found inside the storage, and drainage dispensers may be passed under the eye’s surface in cases of emergency approved by the competent health authority. In this case, all the safety procedures must be taken.
- In case of establishing toilets, toilets must be established in a separate place and have a door that does not open onto places dealing with the public or the storage of the pharmaceutical products, it must have a window open on a street or a skylight, ventilation should be used and the toilet must be disposed on a private inspection room operated on public sewage.
- No part of the property shall be rented to another person or used for any other purpose for which it is licensed.
- Materials or tools other than the materials and tools necessary for the work licensed by the Pharmaceutical institutions shall not be found.
- No animals or birds shall be present at the pharmaceutical institution.
- Ensure that the pharmaceutical institution complies with the latest engineering chart approved by the competent authorities, and no modification is allowed before obtaining written approval from the competent health authority.
- The space of public, private, governmental or commercial pharmacies and their proceeds shall not be less than 40 square meters (For warehouses or warehouses of pharmaceutical intermediaries must not be less than 500 square meters and may be divided on two levels and they shall be separated from any other activity, and pharmaceutical factories need to allocate sufficient space to meet the manufacturing requirements of the World Health Organization (WHO).
- The original license and the copy of the approved engineering drawing and the register of the licensed workers must be kept at the institution including the license of practice the profession of the Egyptian director in charge and the Egyptian constitution of the medicines to be submitted if requested.
- The warehouses of intermediaries, warehouses and shops of trafficking in medicinal plants and their proceeds shall be exempted from the requirements of the water supplier and drainage method stating that there are no watercourses inside.
- Regarding the requirements conditions of pharmaceutical factories, Ministerial Decision No. 265 of 1981 is applicable regarding the conditions and technical requirements to be met in the pharmaceutical factories and Ministerial Decision No. 539 of 2007 regarding the adoption of the Egyptian Code for good manufacturing practice “GMP” methods for pharmaceuticals.
Packaging and Labelling of Medicines and Devices:
The Medicines must be sold from the storage in their own original packaging. If portioned, they shall have to be inside airtight packages, bearing thereupon labels in the name of the storage, its address, name of the manager, name of the substances, its strength and pharmacopeia by means of which they were prepared, amount thereof, factory from which they were imported or in which they were made as well as the expiry dates, if any. If they are prepared for veterinary use, that must be indicated on the card, as per Article 49 of the Pharmaceutical Profession Law No. 127 of the year 1955.
Moreover, Article 63 of the same law states that the special and pharmacopeial pharmaceutical preparations must be sold duly wrapped inside their original wrappings, with the exception of the ampoules or injections in case the name of the medicine, its quantity, and the name of the preparing factory will be printed thereupon in a fixed substance difficult to be removed. The information and details stated on the labels of the pharmaceutical preparations and in the pamphlets and advertisements related thereto must comply with the actual contents of those preparations in terms of substances, and with their therapeutically characteristics. They must avoid containing phrases which would conflict with public ethics, or which would misguide the public. It is necessary to obtain the approval of the technical committee for Medicine Control at the Ministry of Public Health as to the context of those items of information, or pamphlets or advertisements and their means prior to the publications.
Moreover, Ministry of Health Decree 425/2015 and the Guidelines for Outer Label of Pharmaceutical Products issued by CAPA regulates packaging and labelling. The competent regulatory authority is the naming committee at CAPA. Ministry of Health Decree no. 26/2016 requires all medicinal products to have the barcode for the Global Trade Item Number.
14. What information must be included in medicine and device labeling?
In case of medicines: Ministry of Health Decree 425 of the year 2015 and the Guidelines for Outer Label of Pharmaceutical Products issued by CAPA regulates packaging and labelling. The competent regulatory authority is the naming committee at CAPA. According to the regulations of the Ministry of Health, require all medicinal products to have the barcode for the Global Trade Item Number.
The outer label must contain the following information:
- Trade name as approved by CAPA;
- Active ingredients under the trade name and on the side of the package;
- Pharmaceutical form under the active ingredients;
- Number of units per pack;
- Route of administration;
- Any other ingredients if they are not mentioned in the leaflet;
- Storage conditions;
- Special precautions;
- Information on the manufacturer (name, address, city, country, phone, fax, website) and license holder (logo or trade mark);
- Barcode of the product;
- Batch number;
- Production and expiry dates;
- The dosage form or the product if it relates to a specific group (infant, children, adults, men, and women);
- The approved price for each unit and the whole package;
- All drugs must state “keep out of the reach of children”; and
- Other contents in the package must be mentioned on the outer label (if any, for example, measuring cup, applicator, dropper, syringe, calibrating dropper, and so on).
All information on the outer label must be written in both Arabic and English. Further, the design and color of the outer label must differ from that of competitor products.
In case of dietary supplements, a ribbon (15% of the package size) must encircle the package. In this ribbon, the words “Dietary Supplement” must be written, in both English and Arabic.
In case of Medical devices:
All medical devices must be labelled in accordance with the requirements of the legislation and related standards, e.g. ISO- 15223-1-2007: medical devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General requirements. While the packaging should contain the CE, which means that the device satisfies the relevant essential requirements and is fit for its intended purpose as specified by the manufacturer. All medical devices, (except custom-made devices and those intended for clinical investigations) must bear a CE mark.
15. What additional information may be included in labeling and packaging?
According to Decree No. 76 of the year 2000, the information included in the packaging, labeling shall be clear and precise with no ambiguous words and can be easily recognized, and the information shall be kept at MOH in Arabic language and does not contradict with the information listed in the reference country.
16. What items may not be included in labeling and packaging?
Any information included in labelling, packaging or even marketing/advertising must not contain any phrase, which would conflict with the public ethics or which would misguide the consumers as per Article 63 of the Pharmaceutical Profession Law No. 127 of the year 1955.
17. What are the restrictions and requirements for the marketing and advertising of medicines and devices?
Advertising of medicinal products is regulated under Law no.206/2017 regulating the advertising of health products and services. The competent regulatory authority to review and approve advertising materials is a higher committee to be formed by the Prime Minister. This committee will issue advertising permits.
Advertising prescription pharmaceuticals is limited to licensed medical professionals. Addressing marketing or advertising of prescription pharmaceuticals to patients is not allowed. The technical committee at the Ministry of Health must approve the content of the advert or any marketing materials before its use.
While, in order to get a marketing authorization, the following shall be as follows:
A request for obtaining the marketing authorization shall be submitted to the CAPA according to the form, in addition to the annexes, documents, materials and samples. The application in question shall be delivered in return for a receipt acknowledging the quality of the attachments from the information provided in the documents and samples.
Further on, the request, its components and attachments will be reviewed by the Head of the CAPA, who refers the request to the competent entity that deals with it in all the stages necessary to complete the examination, evaluation and testing. It is not permitted for the non-employees to be present in various work sites, it is not permitted as well for them to trade, transfer, deliver the request or any of its contents, attachments or samples accompanying it to any of the competent authorities or any of its employees.
The Examination Committee shall be responsible of scrutinizing the application, attachments, and annexes thereto as well as the accompanying samples in order to ensure the availability of the basic requirements necessary for the validity of trading the pharmaceutical in the market. In the regard of evaluating the situation, the Committee uses the information available to it and the supportive information, data and studies provided by the concerned person on the pharmaceutical and the active ingredient thereof in terms of: medical classification, biological efficiency, drug/medical usage, indications and contraindications, the warnings that accompany usage, pharmaceutical’s known interactions (or the active ingredient thereof) with the other medicines (or with food), the potential side effects that accompany the normal usage and upon exceeding the defined dosage, acute and chronic toxicity, pharmaceuticals dosage forms, the strength (or concentration) of the active ingredient in the dosage, the dose recommended to be used in the different health conditions (or illness conditions), and the other characteristics of the pharmaceutical product (or the active ingredient thereof) in addition to determining the level of safety of use upon the normal usage of the pharmaceutical as well as mentioning the studies conducted for evidencing all of the aforementioned.
During presenting the aforementioned data and information, the applicant shall submit the supporting studies and reports, the applicant shall also determine whether such studies and reports as well as the data and information included therein are published in specialized scientific journals and shall determine its references, or published in general media platforms such as the internet, media and promotional leaflets and publications together with the data of bio-equivalence that the applicant wishes to submit.
The applicant shall as well submit the data of the pharmaceutical’s exclusivity in the field marketing (along with mentioning the dates) in the country of origin and the other countries as well as the official authorities that tested such pharmaceutical and licensed it in such countries, and the pharmaceutical dosage forms that have been already tested and traded within such markets.
The applicant shall also submit information concerning the cost and elements thereof required for evaluating the price of selling to consumer in Egypt as well as information concerning the price of selling to consumer (regarding the pharmaceutical dosage forms and its different concentrations) in the country of origin and the countries where the pharmaceutical is traded.
In carrying out its duties and evaluating the situation, the Examination Committee is further assisted with the Assistive Technical Bodies through the Drug Policy and Planning Center, including the Pharmacology Committee, the Specialized Scientific Advisers Group, and the Drug Pricing Committee.
According to what is decided by the Examination Committee, the concerned person shall, through the aforementioned office at the Central Administration for Pharmaceutical Affairs, submit the additional information and data in relation to the works carried out by the National Organization for Drug Control and Research and to submit as well the reference samples of the active ingredient and the other elements of the pharmaceutical product.
The Chairman of the CAPA may ask the applicant to submit the information relevant to the methods of analysis of the active ingredients and other ingredients of the pharmaceutical products if the National Organization for Control and Drug Research requests so. In the event that such information and additional data are undisclosed information pursuant to the definitions stated in Article No. (56) of Law No. 82 of the year 2002, hence, such information shall not be disclosed to any third party nor shall be used for any unfair commercial purposes.
The National Organization for Control and Drug Research;
The said organization shall be responsible for the examination and testing procedures as well as the qualitative and quantitative analyses of the pharmaceuticals’ active ingredients and other ingredients, additives, flavors, fillers, colorants, flavorings and odorant agents.
Pursuant to the studies and the works carried out at the laboratories of the NOCDR the organization may give a notice of the pharmaceuticals’ fulfillment/ non-fulfillment of the necessary requirements.
In addition, the organization may decide on its need for further information, data, samples or reference materials to resume its studies. In such a case, it shall notify the Chairman of the Central Administration for Pharmaceutical Affairs of its need, and then the latter informs the applicant thereof, through the afore-mentioned office in order to provide the specified requirements within a definite period. In the event that the NOCDR issues its decision of the non-conformity of the pharmaceutical with the Authority’s specifications, the said organization shall as well prepare its report including the Organization’s justifications so that the applicant shall be informed thereof through the afore-mentioned office. A liaison officer appointed by the organization shall be responsible for moving the application and the decisions issued thereon, between the National Organization for Control and Drug Research and the Central Administration for Pharmaceutical Affairs.
Moreover, the Drug Pricing Committee practices its work to reach a reasonable evaluation for the pharmaceutical’s price to be incurred by the customer. The said committee works through negotiation with the applicant; and relying on the correct information that is available concerning the cost elements. It may also bear into consideration the sale price to the customer that is used in other countries for the same pharmaceutical with the same concentration.
The Technical Committee for Drug Control:
The said committee takes the final decision based upon all the information given by the Examination Committee together with the issued decisions and the views reached by other concerned bodies. If the final decision approves of the trading of a pharmaceutical in the Egyptian market, the Technical Committee for Drug Control consequently approves issuing a registration number for the said pharmaceutical, which marks a sign of marketing approval together with a determination of the sale price for the customer. In case the final decision does not approve of the pharmaceutical, the applicant shall be informed thereof, through the afore-mentioned office, together with a statement of the reasons and justifications for the decision.
18. Where can medicines and devices be sold or delivered? Can medicines and devices be sold or delivered via post?
Medicines are sold from distributors and wholesale stores that are licensed and approved by the Ministry of Health or from the producing companies to licensed pharmacies, which sells the products to the patients. There is no Law or Regulation that mentions selling medical products online; however, Law prohibits the sale of prescription pharmaceuticals without a valid prescription by a licensed physician.
19. What are the restrictions and requirements for electronic marketing and advertising via email, by Internet, social media, and other channels?
Internet advertising is not regulated by Ministry of Health decrees. A few companies have obtained CAPA consent to run internet webpages including marketing materials, without requiring the pre-approval of the technical committee. The position of CAPA on this matter is not consistent.
Pharmaceutical companies are currently required to obtain pre-approval of any marketing or advertising materials before publishing them on a webpage.
The authors expect CAPA to issue guidelines to address this subject in more detail.
20. May medicines and devices be advertised or sold directly to consumers?
Yes, medicines and devices can be advertised directly to the consumers according to the Code No. FM-PMA-01 issued by the Marketing materials and media monitoring. Promotional materials directed to the public must include:
- The active ingredient(s) name(s).
- The trade name.
- Major indications for use.
- Major precautions, contra indications & warnings, side effects (incidence> 1%).
- Name and address of manufacturer or distributor.
- Price information must be honest and accurate.
- References to scientific literature as appropriate.
- CAPA approval number and invalidation date of the promotional material.
Regarding selling medicines directly to the consumers, medicines cannot be sold directly to the consumers, as drugs cannot be sold unless by licensed pharmacies, which buys the medical products and devices from distributors and wholesale stores that are licensed and approved by the MOH or from any producing companies.
21. How is compliance monitored?
CAPA has an inspection department, which ensures the compliance of the factories with the WHO Guidelines on Good Manufacturing and local regulations.
22. What are the potential penalties for noncompliance?
In case the inspection department found the non-compliance of the factories with the GMP and local regulations, thereof the license will be cancelled or suspended.